Organon & Co. (‘Organon’), a global healthcare company, primarily focuses on improving the health of women throughout their lives.
The company develops and delivers innovative health solutions through a portfolio of prescription therapies and medical devices within women’s health, biosimilars, and established brands. The company has a portfolio of more than 70 medicines and products across a range of therapeutic areas. It sells these products through various channels, including drug wholesalers...
Organon & Co. (‘Organon’), a global healthcare company, primarily focuses on improving the health of women throughout their lives.
The company develops and delivers innovative health solutions through a portfolio of prescription therapies and medical devices within women’s health, biosimilars, and established brands. The company has a portfolio of more than 70 medicines and products across a range of therapeutic areas. It sells these products through various channels, including drug wholesalers and retailers, hospitals, government agencies, and managed health care providers, such as health maintenance organizations, pharmacy benefit managers, and other institutions. The company operates six manufacturing facilities, which are located in Belgium, Brazil, Indonesia, Mexico, the Netherlands, and the United Kingdom.
The company also manufactures a range of products for third parties, including Merck & Co., Inc. (‘Merck’) products at each of the company’s six manufacturing sites pursuant to third-party contract manufacturing agreements.
The company’s operations include the following product portfolios:
Women’s Health: The company’s women’s health portfolio of products is sold by prescription primarily in two therapeutic areas: contraception, with key brands, such as Nexplanon (etonogestrel implant) (sold as Implanon NXT in some countries outside the United States), and NuvaRing (etonogestrel / ethinyl estradiol vaginal ring), and fertility, with key brands, such as Follistim AQ (follitropin beta injection) (marketed in most countries outside the United States as Puregon). Nexplanon is a long-acting reversible contraceptive, and is in a class of contraceptives that is recognized as one of the most effective types of hormonal contraception available to patients, with a low long-term average cost. The company’s other women’s health products include the Jada System, which is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, and a license from Daré Biosciences for the global commercial rights to Xaciato (clindamycin phosphate vaginal gel, 2%), an FDA-approved medication for the treatment of bacterial vaginosis (‘BV’) in females 12 years of age and older.
Biosimilars: The company’s biosimilars portfolio spans across immunology and oncology treatments. The company’s oncology biosimilars, Ontruzant (trastuzumab-dttb) and Aybintio (bevacizumab), have been launched in more than 20 countries, and its immunology biosimilars, Brenzys (etanercept), Renflexis (infliximab-abda), and Hadlima (adalimumab-bwwd), have been launched in five countries. All five biosimilars in the company’s portfolio have launched in Canada, and three biosimilars, Ontruzant, Renflexis, and Hadlima, have launched in the United States.
Established Brands: The company has a portfolio of established brands, which includes leading brands in cardiovascular, respiratory, dermatology, and non-opioid pain management. Most brands in the company’s established brands portfolio (with the exception of Emgality (galcanezumab-gnlm), Rayvow (lasmiditan), and Vtama (tapinarof)) lost exclusivity years ago and have faced generic competition for some time.
Led by the women’s health portfolio, coupled with an expanding biosimilars business and a stable franchise of established brand medicines, the company’s products produce sufficient cash flows to support investments in innovation and future growth opportunities in women’s health. In addition, the company is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging the company’s scale and presence.
In 2024, the company expanded its product portfolios through the following acquisitions and licenses:
In October 2024, the company acquired Dermavant Sciences Ltd. (‘Dermavant’), a company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s novel product, Vtama 1%, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults, was approved by the U.S. Food and Drug Administration (‘FDA’) in May 2022. In December 2024, the FDA approved Vtama for an additional indication of topical treatment of atopic dermatitis, also known as eczema, in adults and children two years of age and older.
In September 2024, the company entered into license and supply agreements with Suzhou Centergene Pharmaceuticals (‘Centergene’), acquiring the exclusive commercialization rights to Centergene’s investigational asset, SJ02, in China. SJ02 is a long-acting recombinant human follicle-stimulating hormone carboxyl-terminal peptide fusion protein (FSH-CTP) designed for controlled ovarian stimulation (‘COS’) in combination with a gonadotropin-releasing hormone (‘GnRH’) antagonist. It is used to facilitate the development of multiple follicles in women undergoing assisted reproductive technology (‘ART’) programs.
In August of 2024, the company expanded its agreement with Eli Lilly (‘Lilly’) to become the sole distributor and promoter for Emgality in the following additional markets: Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey, and the United Arab Emirates. The company’s original agreement with Lilly provided it with sole distribution rights only in Europe. Emgality, a humanized monoclonal antibody calcitonin gene-related peptide (‘CGRP’) antagonist, is indicated for the preventive treatment of migraine in adults, and in some markets, the indication specifies prophylaxis for those with at least four migraine days per month. Emgality is also indicated in some markets for the treatment of episodic cluster headache in adults.
Products
The company is engaged in both developing and delivering innovative health solutions through a diverse portfolio of products. These products serve patient needs across multiple therapeutic areas and product categories of women’s health, biosimilars, and established brands.
The company operates on a global scale through a global network that enables it to distribute products to patients in more than 140 countries and territories, with approximately 75% of its 2024 revenues generated outside the United States.
Women’s Health Portfolio
In 2024, the company’s women’s health portfolio accounted for approximately 28% of its total revenues, with $846 million, or approximately 48%, generated outside the United States. The company’s women’s health products are sold by prescription primarily in two therapeutic areas: contraception (which includes key brands, such as Nexplanon and NuvaRing), and fertility (which includes key brands, such as Follistim AQ and Elonva (corifolitropina alfa)). Additionally, the company continues to assess commercialization opportunities in conditions that are either unique to women, disproportionately affect women, or impact women differently than men. The company’s women’s health products are sold in over 90 markets worldwide, including the United States, China, Canada, Australia, Brazil, and Mexico, as well as many other countries in the European Union (the ‘EU’), South America, Asia, and Africa.
Contraception
The company’s contraception portfolio currently consists of the following products, which work to prevent pregnancy primarily by suppressing ovulation:
Nexplanon is a prescription medication for the prevention of pregnancy in women. It consists of a small, thin, and flexible arm implant that is placed discreetly under the skin of the inner, upper non-dominant arm by a health care provider. It is a progestin-only, radiopaque, removable implant, containing 68 mg of etonogestrel that is pre-loaded into an applicator. It is typically prescribed to women who are not looking to become pregnant in the near future and do not want to take a daily contraceptive. The product is currently indicated for a period of up to three years of use (at which point the insertion must be removed). It is also reversible, meaning that a woman can have it removed at any time after insertion. An application for a five-year duration period of use was submitted to the FDA in December 2024 and is currently undergoing regulatory review. Subject to such review, the company currently expects that any U.S. approval could occur as early as 2025. If approved, the company could receive an additional three years of market exclusivity for Nexplanon in the United States. The company plans to make a similar application for review by EU regulators in 2025. Subject to such review, the company currently expects that any potential EU approval could occur as early as 2026.
NuvaRing is a monthly vaginal contraceptive ring with a combination of progestin and estrogen used to prevent pregnancy in women. NuvaRing is typically prescribed for women that want a monthly contraceptive option.
Cerazette (desogestrel) is a progestin-only, daily pill used to prevent pregnancy in women. Progestin-only products, like Cerazette, are typically used by women who want hormonal contraception but for whom estrogen-containing contraceptives may not be medically appropriate. Cerazette is not approved or marketed in the United States but is available in certain countries outside the United States.
Marvelon (desogestrel and ethinyl estradiol pill) and Mercilon (desogestrel and ethinyl estradiol pill) are both combinations of progestin and estrogen that are used as daily pills to prevent pregnancy. Marvelon contains a higher daily dose of estrogen than Mercilon. These medicines are not approved or marketed in the United States but are available in certain countries outside the United States. Mercilon is being evaluated for the treatment of dysmenorrhea (lower abdominal pain immediately prior to or during menstruation), and the company expects to make a regulatory submission for the same indication to Japan’s Pharmaceutical and Medical Device Agency (the ‘PMDA’) in 2025. Subject to such review, the company currently expects that any potential Japanese PMDA approval could occur as early as 2026; however, there can be no assurance that such approval will be granted.
Fertility
The company’s fertility brands include the following products, which are primarily used for medically-assisted reproduction (‘MAR’) and/or in vitro fertilization (‘IVF’) treatment cycles:
Follistim AQ, which is marketed as Puregon in most countries outside the United States, contains human follicle-stimulating hormone (‘FSH’) and is used to promote the development of multiple ovarian follicles in MAR procedures. Such procedures include IVF, intracytoplasmic sperm injection, and embryo transfer. Follistim AQ belongs to the group of gonadotropic hormones used by women trying to conceive using IVF.
Elonva (which is not available in the United States) is a sustained follicle stimulant with the same mechanism of action as recombinant FSH. Due to its ability to initiate and sustain the growth of multiple ovarian follicles for an entire week, a single subcutaneous injection of the recommended dose of Elonva may replace the first seven injections of any daily gonadotropin preparation in an ovarian stimulation treatment cycle. Elonva belongs to the group of gonadotropic hormones used by women trying to conceive using MAR and/or IVF.
Ganirelix acetate injection (marketed in certain countries outside the United States as Orgalutran) is an injectable GnRH antagonist used to prevent luteinizing hormone surges. Ganirelix acetate injection is used in fertility treatments in combination with FSH.
Postpartum Hemorrhage
Jada is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. Jada uses a low-level vacuum to encourage the physiologic contraction of the uterus to control bleeding. Jada is available in the United States at a majority of hospitals that offer labor and delivery services and is also available in several markets outside of the United States. The company is considering options for future market expansion in additional markets globally.
Bacterial Vaginosis
Xaciato is an FDA-approved medication for the treatment of BV in females 12 years of age and older, which is licensed through an agreement with Daré Biosciences.
Xaciato is available in the United States; however, the company plans to assess opportunities to seek potential further marketing authorizations for countries outside the United States.
Biosimilars Portfolio
A biosimilar is a biological medicine that is highly similar to another biological medicine that has already been approved by the FDA. In 2024, the company’s biosimilars portfolio accounted for approximately 10% of its total revenues, or approximately 47%, generated outside the United States. The assets in its biosimilars portfolio, coupled with its commercial experience in biosimilars, provide an opportunity to benefit from future growth anticipated in this area.
Biosimilars Products
The company’s biosimilars portfolio consists of therapies in immunology and oncology for which it has worldwide commercialization rights with certain geographic exceptions specified on a product-by-product basis. Such exceptions are governed by agreements that the company entered into with Samsung Bioepis and Shanghai Henlius Biotech, Inc. (‘Henlius’). The marketed portfolio consists of three immunology products, Hadlima (Originator brand name: Humira; generic name: adalimumab), Brenzys (Originator brand name: Enbrel; generic name: etanercept), and Renflexis (Originator brand name: Remicade; generic name: infliximab). The marketed portfolio also consists of two oncology products, Ontruzant (Originator brand name: Herceptin; generic name: trastuzumab) and Aybintio (Originator brand name: Avastin; generic name: bevacizumab).
Hadlima (SB5)
Hadlima (adalimumab-bwwd) is a tumor necrosis factor (‘TNF’) antagonist biosimilar to AbbVie’s Humira (adalimumab) product, approved for use in certain patients for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, plaque psoriasis, suppurativa, and uveitis. The company has worldwide commercialization rights to Hadlima in countries outside the EU, Korea, China, Turkey, and Russia. Samsung Bioepis reached a global settlement with AbbVie permitting the company to launch Hadlima outside of the United States starting in 2021 and in the United States in July 2023. Hadlima is approved in the United States, Australia, Canada, Brazil, Ukraine, New Zealand, Qatar, Israel, and Saudi Arabia, and marketed in the United States, Australia, Canada, Puerto Rico, Brazil, and Saudi Arabia. Hadlima was approved by the FDA in July 2019 as a low-concentration (50mg/ml) formulation. In August 2022, the FDA approved the citrate-free, high-concentration (100 mg/mL) formulation of Hadlima. In November 2023, the FDA accepted for review the Supplemental Biologics License Application (sBLA) for the interchangeability designation for Hadlima.
Brenzys (SB4)
Brenzys (etanercept) is a TNF antagonist biosimilar to Amgen/Pfizer’s Enbrel (etanercept) product. It is approved for use in certain patients for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. The company has commercialization rights to Brenzys in countries outside the EU, Korea, China, Japan, and the United States, and Brenzys is currently approved in Australia, Canada, Brazil, Israel, Ukraine, New Zealand, the United Arab Emirates, Qatar, and Kuwait. It is also commercialized in Australia, Canada, Brazil, and Israel.
Renflexis (SB2)
Renflexis (infliximab-abda) is a TNF blocker biosimilar to Johnson & Johnson’s Remicade (infliximab) product. It is approved for use in certain patients for the treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The company has worldwide commercialization rights to Renflexis in countries outside the EU, Korea, China, Turkey, and Russia. It is approved for commercialization in the United States, Australia, Canada, Ukraine, Saudi Arabia, New Zealand, the United Arab Emirates, Qatar, and Kuwait, and commercialized in the United States, Puerto Rico, Australia, Canada, and Brazil.
Aybintio (SB8)
Aybintio (bevacizumab) is a vascular endothelial growth factor inhibitor biosimilar to Roche’s Avastin (bevacizumab) product. Aybintio is currently approved and commercialized in the EU and Canada for use in certain patients with metastatic carcinoma of the colon or rectum, metastatic non-squamous, non-small cell lung cancer, metastatic renal cell carcinoma, metastatic cervical cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer, and metastatic breast cancer. The company has commercialization rights to Aybintio in the United States, Canada, Germany, Italy, France, the UK, and Spain.
Ontruzant (SB3)
Ontruzant (trastuzumab-dttb) is an HER2/neu receptor antagonist biosimilar to Roche’s Herceptin (trastuzumab) product for the treatment of HER2 overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma consistent with Herceptin. The company has worldwide commercialization rights to Ontruzant in countries outside of Korea and China. Ontruzant is approved in the United States, Canada, Australia, New Zealand, EU countries, the United Kingdom, Brazil, Ukraine, Saudi Arabia, Qatar, and Kuwait, and marketed in the United States, Puerto Rico, Canada, EU countries, Ukraine, and Brazil.
Established Brands Portfolio
The company’s established brands portfolio includes leading brands in cardiovascular, respiratory, dermatology, and non-opioid pain management. Most brands in the company’s established brands portfolio (with the exception of Emgality, Rayvow, and Vtama) lost exclusivity years ago and have faced generic competition for some time. In 2024, the company’s established brands portfolio contributed approximately 92% generated outside the United States. Generic competition varies significantly across geographies.
Cardiovascular
In 2024, the company’s cardiovascular portfolio accounted for approximately 21% of its total revenues, nearly all of which were generated outside the United States.
The company’s cardiovascular portfolio consists of several cholesterol-modifying medicines, including: Zetia (ezetimibe), which is marketed as Ezetrol in most countries outside the United States; Vytorin (ezetimibe / simvastatin), which is marketed as Inegy outside the United States; Atozet (ezetimibe and atorvastatin), which is marketed in certain countries outside the United States; Rosuzet (ezetimibe and rosuvastatin), which is also marketed in certain countries outside the United States; and Zocor (simvastatin), which is also available in certain countries outside the United States, including China. The company’s cardiovascular portfolio also includes Cozaar (losartan) and Hyzaar (losartan / hydrochlorothiazide), which are cardiovascular drugs for the treatment of hypertension.
Respiratory
In 2024, the company’s respiratory portfolio accounted for approximately 16% of its total revenues, with approximately 79% generated outside the United States.
The company’s respiratory portfolio consists of several treatments used to control and prevent asthma-induced symptoms, including: Singulair (montelukast sodium), Dulera (formoterol/fumarate dihydrate), which is also marketed as Zenhale in certain markets outside the United States, and Asmanex (mometasone furoate).
The company’s established brands portfolio also includes several products that treat seasonal allergic rhinitis, including: Singulair, Nasonex (mometasone), and Clarinex (desloratadine), which is marketed as Aerius outside of the United States. The company owns prescription rights for Clarinex in the United States and Aerius in markets around the world.
Dermatology, Bone Health, and Non-Opioid Pain Management
In 2024, the company’s dermatology, bone health, and non-opioid pain management portfolios accounted for approximately 14% of its total revenues, nearly all of which were generated outside the United States.
The company’s dermatology portfolio currently consists of three core products, including: Vtama, a topical treatment for mild, moderate, and severe plaque psoriasis in adults and atopic dermatitis, also known as eczema, in adults and children two years of age and older, which was acquired through its acquisition of Dermavant in October 2024; Diprosone (betamethasone cream), a corticosteroid approved for treatment in relief of skin conditions; and Elocon (mometasone cream), a topical prescription medicine approved for treatment in relief of inflammation and other symptoms caused by certain skin conditions.
The company’s bone health portfolio includes Fosamax (alendronate sodium), a bisphosphonate medicine used for the treatment and prevention of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.
The company’s non-opioid pain management portfolio consists of three core products, including: Arcoxia (etoricoxib), a selective cyclooxygenase-2 inhibitor used for acute and chronic treatment of conditions, such as acute pain, osteoarthritis, and rheumatoid arthritis; Diprospan (betamethasone), an injectable glucocorticoid drug approved for the treatment of conditions, such as bursitis, dermatological disorders, and inflammatory conditions; and Celestone (betamethasone injectable suspension), a sterile aqueous suspension approved for the treatment of inflammation and conditions, such as endocrine disorders and gastrointestinal diseases.
Other Established Brands
In 2024, this category accounted for approximately 10% of its total revenues, nearly all of which were generated outside the United States. This category includes the company’s mature products across various therapeutic areas, which remain significant to its product portfolio.
The company is party to a distribution agreement with Lilly for Emgality in Canada, Colombia, Europe, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey, and the United Arab Emirates.
Additionally, this category covers other mature products, such as: Proscar (finasteride), used for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate, and Propecia (finasteride), used for the treatment of male pattern hair loss.
Research and Development
As part of the company’s growth strategy, it seeks to continue to identify scientific collaborations and acquisitions to further build and maintain an industry-leading pipeline across women’s health with both early- and late-stage assets that enable scientific and commercial leadership and continue to solidify its position as a women’s health partner of choice.
The company’s science spans the full research and development lifecycle, from discovery through Phase IV studies, and is driven by seasoned researchers, scientists, regulatory, pharmacovigilance, and medical affairs experts. OB/GYNs, PhDs, nurses, and pharmacists are invaluable parts of its team, helping it to better understand women’s needs from the perspectives of clinicians, physicians, and patients.
As of December 31, 2024, the company had licenses to commercialize the following development stage products:
Regulatory Development:
HLX14, a biosimilar candidate to Amgen's Prolia/Xgeva (denosumab), is a recombinant anti-RANKL human monoclonal antibody. Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. The company has worldwide commercialization rights to HLX14 in countries except for China (including Hong Kong, Macau, and Taiwan). Henlius is responsible for the development of this product and, if approved, will supply the products to the company.
HLX11, a biosimilar candidate to Roche's Perjeta (pertuzumab), is an anti-HER2 domain II humanized monoclonal antibody. Pertuzumab, in combinations with trastuzumab and chemotherapy, is used for the treatment of certain patients with HER2+ breast cancer. The company has worldwide commercialization rights to HLX11 in countries except for China (including Hong Kong, Macau, and Taiwan). Henlius is responsible for the development and, if approved, will supply the products to the company.
SJ02 is a long-acting recombinant human follicle-stimulating hormone carboxyl-terminal peptide FSH-CTP. SJ02 is designed for COS in combination with a GnRH antagonist to facilitate the development of multiple follicles in women undergoing ART programs. SJ02 is designed to initiate and maintain follicular growth in the ovaries for one week. If approved, a single-dose injection of SJ02 has the potential to offer an alternative to the current treatment regimen. The company has exclusive commercialization rights in China. Centergene is responsible for the development of this product and, if approved, will supply the product to the company.
Clinical Pharmaceutical Development:
OG-6219, a HSD17ß1 inhibitor, is an investigational agent being evaluated as a potential treatment for endometriosis. Endometriosis is a common and chronic condition that affects up to one in 10 women of reproductive age, causes abdominal pain, and is associated with infertility. Approximately 10% of premenopausal women are diagnosed with endometriosis, and diagnosis occurs an average of seven years after the development of symptoms. Therapies are predominantly hormonal treatments, which are not generally suitable for long-term use, and frequent surgical interventions may be required. OG-6219 is a non-hormonal treatment with a novel mechanism of action. As there are currently limited treatment options for women with endometriosis, this represents a priority disease area for the company.
OG-7191, a HSD17ß5 inhibitor, is a preclinical program targeting polycystic ovarian syndrome (‘PCOS’), one of the most common women's health conditions often associated with metabolic disorders, hyperandrogenism, and infertility. PCOS is a lifelong chronic disorder and is associated with infertility as a result of menstrual cycle disruption. Approximately 10-13% of women worldwide suffer from PCOS. The company’s OG-7191 program aims to directly target the root cause of PCOS and the underlying pathophysiology of this condition. As there are currently no approved therapies for PCOS, this represents another priority disease area for the company.
OG-9489 is an investigational non-hormonal, on-demand contraceptive candidate. In the United States, approximately 65% of women aged 15–49 use some form of contraception, with a growing proportion of these women seeking non-hormonal reliable contraception. The company has entered into a research collaboration and exclusive license agreement with Cirqle Biomedical (‘Cirqle’) for this novel investigational candidate. Under the terms of the agreement, Cirqle is responsible for conducting preclinical studies according to the mutually agreed research plan, and if successful, the company will have exclusive worldwide rights to develop and commercialize the product.
MedTech Development:
The Claria System is an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy. In 2023, the company made a strategic investment in Claria Medical, Inc. (‘Claria’). Under the terms of that agreement, Claria is responsible for conducting clinical studies according to the mutually agreed research plan. With approximately 600,000 hysterectomies performed annually in the United States alone, hysterectomy is one of the most performed surgeries for women. Claria’s investigational device uses a uterine containment and extraction system that aims to improve the hysterectomy procedure for both patients and physicians by providing a faster, simpler, and safer procedure. This technology has been granted Safer Technology designation by the FDA. The Safer Technologies designation does not confer FDA marketing clearance or approval but is given to devices that are, among other things, reasonably expected to significantly improve the safety of available treatments or diagnostics that target an underlying disease or condition. The company’s agreement with Claria also gives it the option to acquire Claria.
Sales, Marketing, and Distribution Capabilities
Sales and Marketing
The company has approximately 4,000 employees worldwide focused on commercialization activities, such as marketing, direct sales, digital and omni-channel, and insight generation, data stewardship, data analytics, and data science. The company has a global team of experienced marketers, pricing and access professionals, and data scientists.
The company has a trade channel strategy that provides a robust capability framework for its activities, including the selection of channel partners, commercial terms, and supportive health care services that promote the efficient, safe, and cost-effective delivery of its products. The company has significant insight into the use of newer technologies and the use of valuable patient services, such as patient adherence programs, that can further drive value in collaboration with its trade partners.
Distribution
The company’s global network enables it to distribute products directly and indirectly to patients in more than 140 countries and territories, including through its regional distribution centers. The company sells its pharmaceutical products primarily to drug wholesalers and retailers, hospitals, clinics, government agencies, pharmacies, and managed health care providers, such as health maintenance organizations, pharmacy benefit managers, and other institutions. The company also sells its pharmaceutical products through third-party distributors and agents for smaller markets. The company’s professional representatives communicate the effectiveness, safety, and value of its pharmaceutical products to health care professionals in private practice, group practices, hospitals, and managed care organizations.
Intellectual Property
The company has been granted a license from Merck for Nexplanon / Implanon NXT that permits the use of the underlying technology solely as a contraceptive implant containing only the active pharmaceutical ingredient used in the product. The company is also party to a separate licensing agreement with Merck that provides a limited expansion of the fields for which it may use the underlying technology of Nexplanon / Implanon NXT beyond contraception in exchange for milestone payments.
The company considers the patents that cover Nexplanon to be material to its business. The relevant Nexplanon rod patents will expire in 2027 in the United States and in 2025 in other countries around the world. Key aspects of the Nexplanon applicator are patented until 2030 in the United States and 2026 in certain other countries. There are no material contested proceedings or third-party claims that involve the patents that cover Nexplanon. An application for a five-year duration period of use was submitted to the FDA in December 2024, and is undergoing regulatory review, and if approved, the company could receive an additional three years of market exclusivity for Nexplanon in the United States. The company plans to make a similar application for review by EU regulators in 2025.
Primary patent exclusivity for Vtama is provided by patents on topical formulations of tapinarof. These patents expire in May 2036 in the United States and other countries around the world. Additional patents on other aspects of Vtama expire later, and related patent applications are pending.
Privacy and Data Protection
The company is subject to a significant number of privacy and data protection laws and regulations globally, many of which place restrictions on the company’s ability to transfer, access, and use personal data across its business, including healthcare provider information and clinical trial data. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there are privacy and data protection frameworks with the potential to directly affect the company’s business. These include, for instance, the EU General Data Protection Regulation (‘GDPR’), which imposes penalties of up to 4% of global revenue, and China's Personal Information Protection Law (‘PIPL’) and U.S. state privacy laws.
Third-Party Collaboration
The company is party to an agreement with Samsung Bioepis (the ‘Samsung Bioepis Agreement’) that grants it an exclusive license to commercialize the following pre-specified biosimilars products (with reference products in parentheses) developed by Samsung Bioepis: adalimumab (Humira), bevacizumab (Avastin), infliximab (Remicade), trastuzumab (Herceptin), and etanercept (Enbrel).
Under the Samsung Bioepis Agreement, Samsung Bioepis is responsible for pre-clinical and clinical development, process development and manufacturing, clinical trials, and registration of product candidates. The company’s access rights to each product under the Samsung Bioepis Agreement last for ten years from each such product’s launch date on a market-by-market basis. Unless the parties agree to extend the term, the agreement expires upon the expiration of the last such ten-year period.
The Samsung Bioepis Agreement provides that gross profits are shared equally in all markets except for certain markets in Brazil, where gross profits are shared 65% to Samsung Bioepis and 35% to the company. The Samsung Bioepis Agreement also provides for payment of certain milestone license fees associated with pre-specified clinical and regulatory milestones to Samsung Bioepis, payment of the supply price for each product to Samsung Bioepis, and an upfront payment to Samsung Bioepis that was completed by Merck at the commencement of the agreement.
History
Organon & Co. was founded in 1923. The company, a Delaware corporation, was incorporated in 2020.
