Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines.
The company’s Affordable Medicines segment includes retail generics, injectables, and biosimilars. In its Specialty segment, the company offers a portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the company is a distributor of pharmaceuticals and ot...
Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company that develops, manufactures, markets, and distributes a diverse portfolio of essential medicines.
The company’s Affordable Medicines segment includes retail generics, injectables, and biosimilars. In its Specialty segment, the company offers a portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. The company operates principally in the United States (U.S.), India, and Ireland.
Alliance and Collaboration
Collaboration to Develop and Supply Medicines for Obesity and Metabolic Diseases
On September 30, 2024, the company entered into a collaboration agreement to develop and supply a new portfolio of weight loss medicines globally with Metsera, Inc. (‘Metsera’), a clinical stage biopharmaceutical company (the ‘Metsera Agreement’). The company will serve as Metsera’s preferred supply partner for developed markets, including the United States and Europe. In addition, the company has been granted an exclusive license to commercialize Metsera products covered under the agreement in selected emerging markets, including India and certain countries in Southeast Asia, Africa, and the Middle East.
Under the terms of the Metsera Agreement, the company will be responsible for performing certain development activities on behalf of Metsera. Upon Metsera obtaining regulatory approval for any or all the weight loss medicines referred to above, the company will manufacture commercial products on behalf of Metsera.
The company plans to construct two new greenfield manufacturing facilities in India; one for peptide synthesis and one for sterile fill-finish manufacturing.
The initial term of the Metsera Agreement is seven years from the first commercial sale. Metsera has the sole right to renew the agreement for an additional five-year period.
License Agreement with Zambon Biotech
On February 23, 2024, the company entered a license, distribution and supply agreement with Zambon Biotech S.A. (‘Zambon’) granting Zambon the exclusive rights to seek regulatory approval and commercialize IPX203 in Europe (the ‘Zambon License Agreement’). The term for the Zambon License Agreement is 15 years commencing from the commercial launch of the product, which can automatically renew for successive two-year periods unless either party provides notice declining such renewal at least one year in advance. Zambon will be responsible for the performance of all R&D activities, regulatory approval, commercialization, and marketing activities for the territories in the agreement to be conducted to obtain regulatory approval for each product. Upon achieving regulatory approval for products, the company will be responsible for manufacturing and supplying products to Zambon.
As of December 31, 2024, IPX203 had not been approved for sale outside of the United States, where it is marketed as CREXONT. CREXONT (combination of carbidopa and levodopa extended-release capsules) is indicated in the United States for the treatment of Parkinson’s disease.
Knight Therapeutics International S.A. License Agreement
On January 24, 2024, the company entered a 15-year license, distribution and supply agreement with Knight Therapeutics International S.A. (‘Knight’) granting Knight the exclusive rights to seek regulatory approval and commercialize IPX203 in Canada and Latin America (the ‘Knight License Agreement’). The Knight License Agreement will automatically renew for successive two-year periods unless either party provides notice declining such renewal at least one year in advance.
Knight will be responsible for the performance of all R&D activities, regulatory approval, commercialization, and marketing activities for the territories in the agreement to be conducted to obtain regulatory approval for each product. Upon achieving regulatory approval for products, Amneal will be responsible for manufacturing and supplying products to Knight.
As of December 31, 2024, IPX203 had not been approved for sale outside of the United States, where it is marketed as CREXONT.
ONGENTYS License and Supply Agreement
On December 5, 2023, the company entered into a license agreement with BIAL-Portela & Ca., S.A. (‘BIAL’) for the exclusive rights to market and distribute ONGENTYS (opicapone) in the U.S. starting on December 18, 2023, and ending at such time when generic opicapone sales reach certain predetermined thresholds (the ‘BIAL Agreement’). ONGENTYS is BIAL’s proprietary, once-daily, peripherally acting, highly selective catechol-O-methyltransferase inhibitor approved by the U.S. Food and Drug Administration (the ‘FDA’) in 2020 as an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing ‘off’ episodes. Under the BIAL Agreement, the company is responsible for commercialization and marketing of ONGENTYS in the U.S. and BIAL is responsible for manufacturing and supply. The company commenced the distribution of ONGENTYS in early 2024.
Orion Corporation License Agreement
On December 28, 2022, the company signed a long-term license agreement with Orion Corporation (‘Orion’), a globally operating Finnish pharmaceutical company, to commercialize a number of its complex generic products in most parts of Europe, Australia and New Zealand (the ‘Orion Agreement’). The initial term of the Orion Agreement commences upon commercial launch of the products and will continue for eight years. The Orion Agreement will automatically renew for successive two-year terms unless either party declines such renewal in writing at least one year in advance. As of December 31, 2024, the initial term has not commenced.
Licensing and Supply Agreement with mAbxience S.L.
On May 7, 2018, the company entered into a licensing and supply agreement with mAbxience S.L. (‘mAbxience’), for its biosimilar candidate for Avastin (bevacizumab). The company is the exclusive partner in the U.S. market. On April 13, 2022, the FDA approved its biologics license application for bevacizumab-maly, a biosimilar referencing Avastin.
License and Supply Agreement with Kashiv Biosciences LLC
In December 2022, the company entered into a development and supply agreement specific to four generic product candidates with Kashiv Biosciences LLC (‘Kashiv’). Pursuant to the development supply agreement, the company maintained a right of first offer and negotiation to the licensing of each generic product candidate. In March 2024, the company entered into a license and supply agreement with Kashiv for the development and commercialization of a long-acting injectable (the ‘Injectable License and Supply Agreement’). The existing development supply agreement remains effective for the remaining three generic product candidates.
Subject to the terms of the Injectable License and Supply Agreement, the company is responsible for development, regulatory approval, and commercialization of the product candidate in the U.S., whereas Kashiv is responsible for development and regulatory approval of the product candidate for all other territories outside the U.S. Contingent upon Kashiv obtaining regulatory approval outside the U.S., it shall manufacture the commercial supply for Kashiv at a stated price.
Acquisition
Baclofen Franchise
On December 30, 2021, the company entered into an asset purchase agreement with certain entities affiliated with Saol International Limited (collectively, ‘Saol’), a private specialty pharmaceutical company, pursuant to which it agreed to acquire Saol’s baclofen franchise, including Lioresal, LYVISPAH, and a pipeline product under development (the ‘Saol Acquisition’). The Saol Acquisition expanded the company’s commercial institutional and specialty portfolio in neurology and added commercial infrastructure in advance of its entry into the biosimilar institutional market during October 2022. The transaction closed on February 9, 2022.
Segments
The company operates through three segments: Affordable Medicines (formerly known as Generics), Specialty, and AvKARE.
Affordable Medicines
Prescription pharmaceutical products are sold either as branded or generic products. Generic pharmaceutical products have the same active product ingredient (‘API’), dosage form, strength, route of administration, and conditions of use as patented branded pharmaceutical products, are bioequivalent to the brand it copies, and are usually marketed under their chemical (generic) names rather than brand names. Generic pharmaceutical products are intended to provide a cost-effective alternative for consumers while maintaining the safety, efficacy, quality and stability of the branded product, and as such are generally sold at prices below their branded equivalents. Typically, a generic pharmaceutical may not be marketed until the expiration of applicable patent(s) on the corresponding branded product, unless the resolution of patent litigation results in an earlier opportunity to enter the market. Generic manufacturers are required to file and receive approval for an Abbreviated New Drug Application (‘ANDA’) to market a generic pharmaceutical product. Manufacturers of biosimilars are required to file a Biologics License Application (‘BLA’) to introduce, or deliver for introduction, a biologic product into interstate commerce and market the product for one or more indications.
The company’s Affordable Medicines segment includes approximately 270 product families covering an extensive range of dosage forms and delivery systems, including both immediate and extended-release oral solids, powders, liquids, sterile injectables, nasal sprays, inhalation and respiratory products, biosimilar products, ophthalmics, films, transdermal patches and topicals. The company’s focus on developing products that has substantial barriers-to-entry due to complex drug formulations or manufacturing, or legal or regulatory challenges. Focusing on these products allows it the opportunity to offer first-to-file (‘FTF’), first-to-market (‘FTM’) and other high-value products to customers. A generic pharmaceutical product is considered an FTF product if the ANDA filed with respect to such product is the first to be filed for such product. Pursuant to the Hatch-Waxman Amendments, FTF products may receive a statutory 180-day exclusivity period, subject to certain conditions. A generic product that does not qualify as an FTF may still be an FTM product. A generic product is considered an FTM product if it is the first marketed generic version of a branded pharmaceutical. FTF, FTM and high-value products tend to be more profitable and often has longer life cycles than other generic pharmaceuticals.
As of December 31, 2024, the company’s Affordable Medicines segment had 76 products with a pending ANDA and another 56 products in various stages of development in its pipeline, 74% of which are non-oral solid products. The company has an integrated, team-based approach to product development that combines its formulation, regulatory, legal, manufacturing and commercial capabilities. The company’s Affordable Medicines segment has a growing portfolio of institutional injectable products primarily for the U.S. hospital market. The company’s R&D pipeline has prioritized new product innovations in injectables, such as drug/device combinations, peptides, long acting injectables and large volume parenteral bags. The company has expanded its manufacturing capabilities and infrastructure to support the needs of this expanding business with a focus on development, commercialization and scaling a differentiated injectables portfolio. During 2023, the company launched 39 new products, of which 14 were injectables. In May 2023, the FDA approved for manufacturing the company’s fourth and largest injectable site. During 2024, the company launched 22 new products, of which 12 were injectables.
In 2022, the company began to commercialize an initial portfolio of oncology biosimilars in the U.S. Alymsys, a biosimilar referencing Avastin, launched in October 2022, followed by Releuko, a biosimilar referencing Neupogen, in November 2022 and Flynetra, a biosimilar referencing Neulasta, in May 2023. On October 12, 2023, the company announced the addition of two denosumab biosimilars referencing both Prolia and XGEVA to its biosimilar pipeline. The two denosumab products are being developed by mAbxience S.L., a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. To further grow the company’s oncology biosimilars sales, it is focused on serving oncology clinics, integrated health systems and specialty pharmacies. The company is focused on expanding its oncology and biosimilar portfolio with additional molecules, and the company seeks to vertically integrate by expanding its biosimilar capabilities.
In March 2024, the company amended the Kashiv Biosimilar Agreement (as defined in Note 23. Related Party Transactions) to include two additional in-development products, a pre-filled auto-injector delivery system for peg-filgrastim and a pre-filled on-body injector (OBI) delivery system for peg-filgrastim. In July 2024, the company entered into an exclusive license and commercialization agreement with Kashiv Biosciences LLC to distribute and sell Omalizumab, a biosimilar to XOLAIR, in the U.S. and India.
Specialty
The company’s Specialty segment is engaged in the development, promotion, sale and distribution of proprietary branded pharmaceutical products, with a focus on products addressing central nervous system (‘CNS’) disorders, including Parkinson’s disease, and endocrine disorders. The company’s portfolio of products includes CREXONT (combination of carbidopa and levodopa extended-release capsules), RYTARY (extended-release oral capsule formulation of carbidopa-levodopa), UNITHROID (levothyroxine sodium), and ONGENTYS (opicapone). On August 7, 2024, the FDA approved the company’s new drug application (‘NDA’) for CREXONT, previously referred to as IPX203. In September 2024, the company began selling CREXONT, which is indicated for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults. RYTARY is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. ONGENTYS is an add-on treatment to carbidopa/levodopa in patients with Parkinson’s disease experiencing ‘off’ episodes, which the company commenced selling in early 2024 under a license agreement with BIAL-Portela & Ca., S.A. UNITHROID, indicated for the treatment of hypothyroidism, is sold under a license and distribution agreement with Jerome Stevens Pharmaceuticals, Inc.
The company Specialty products are marketed through skilled specialty sales and marketing teams, who call on neurologists, movement disorder specialists, endocrinologists and primary care physicians throughout the U.S. its Specialty segment also has other product candidates that are in varying stages of development.
For Specialty products, the majority of such products’ commercial value is usually realized during the period in which the product has market exclusivity. In the U.S., when market exclusivity expires and generic versions of a product are approved and marketed, there can often be substantial and rapid declines in the branded product’s sales. In 2025, the company expects to lose exclusivity for RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson’s disease.
AvKARE
The company’s AvKARE segment provides pharmaceuticals, medical and surgical products, and services primarily to governmental agencies, predominantly focused on serving the U.S. Department of Defense and the U.S. Department of Veterans Affairs. AvKARE is also a re-packager of bottle and unit dose pharmaceuticals and vitamins under the registered names of AvKARE and AvPAK. AvKARE is also a wholesale distributor of pharmaceuticals, over the counter drugs and medical supplies to its retail and institutional customers that are located throughout the U.S. focused primarily on entities that provide care to low-income and uninsured patients.
Geographic Areas
The company operates in the U.S., India, and Ireland.
Sales & Marketing and Customers
In the U.S. and the Commonwealth of Puerto Rico, the company markets its Affordable Medicines and Specialty products primarily through major wholesalers and distributors, retail pharmacies, mail-order pharmacies, and directly into hospitals and institutions. Most of the company’s Affordable Medicines pharmaceutical products are marketed to large group purchasing organizations (‘GPOs’) and sold through wholesalers, directly to large chain retailers or to mail order customers. The company’s sterile injectable products and biosimilars utilize a dedicated field-based sales force and are generally marketed to GPOs and specialty distributors, and sold through wholesalers, and occasionally directly to large hospitals and institutions. All the company’s wholesalers purchase products and warehouse them for retail drug stores, independent pharmacies and managed care organizations, such as hospitals, nursing homes, health maintenance organizations (‘HMOs’), clinics, pharmacy benefit management companies and mail-order customers. The company’s Specialty segment, which promotes branded pharmaceutical products, employs a team of dedicated field-based sales representatives to engage in the direct marketing and promotion of its branded products to physicians and healthcare providers.
For the year ended December 31, 2024, on a consolidated basis, the company’s four largest customers, Cencora, Inc., McKesson Drug Co., Cardinal Health, Inc., and CVS Health Corporation, accounted for approximately 70% of its net revenue. In total, the company has approximately 1,300 customers (including over 1,100 customers specific to its AvKARE segment), some of which are part of large purchasing groups.
Competition
The company’s principal competitors in the generic/biosimilar pharmaceutical products market include Teva Pharmaceutical Industries Ltd., Viatris Inc., Sandoz Group, Pfizer Inc., Fresenius Kabi KGaA, Hikma Pharmaceuticals PLC, Dr. Reddy's Laboratories Ltd., Amphastar Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., Lupin Pharmaceuticals, Inc., Zydus Pharmaceuticals USA Inc., and Aurobindo Pharma Limited.
The company’s principal competitors in the specialty pharmaceutical products market include Supernus Pharmaceuticals, Inc., Jazz Pharmaceuticals PLC, AbbVie Inc., and Alkermes PLC.
The company’s competitors are other wholesalers, including Cardinal Health, Inc., Cencora, Inc., McKesson Drug Co., and manufacturers / re-packagers, such as Golden State Medical Supply.
Research and Development (R&D)
For the year ended December 31, 2024, the company’s R&D expense was $190.7 million.
Seasonality
Consistent with the U.S. pharmaceutical industry trends, the first quarter of each year is typically the company’s lowest revenue quarter in the year. Certain products within the company’s portfolio are specifically affected by seasonality (year ended December 2024). For example, sales of Adrenaclick (epinephrine injection, USP auto-injector) correlate with allergy seasonality.
Government Regulation
The FDCA, the Public Health Service Act (the ‘PHSA’), the Controlled Substances Act, the regulations that implement these laws and other statutes and regulations govern the development, testing, manufacture, packaging, use, distribution, safety, effectiveness, labeling, storage, record keeping, approval, marketing, sale, and promotion of the company’s products, as well as post-marketing requirements for safety surveillance and reporting.
Various pharmaceutical pedigree laws, such as the Drug Supply Chain Security Act enacted in 2014, require the tracking of all transactions involving prescription pharmaceutical products from the manufacturer to the dispensary (e.g., pharmacy). Compliance with such laws requires extensive tracking systems and tight coordination with customers and manufacturers. The company complies with these laws.
The company’s marketing practices are subject to state laws, as well as federal laws, such as the Anti-Kickback Statute and False Claims Act, intended to prevent fraud and abuse in the healthcare industry.
The company is subject to the Maximum Allowable Cost Regulations, which limit reimbursements for certain generic prescription drugs under Medicare, Medicaid, and other programs to the lowest price at which these drugs are generally available.
Furthermore, the company relies on global supply chains and production and manufacturing processes that are complex and subject to increasing regulatory scrutiny and enforcement, including the Trade Agreements Act and Buy American Act.
The company must meet the requirements of controlled substances laws, such as the Controlled Substances Act, as amended, DEA regulations for certain of its products and activities, and related state requirements. These laws and regulations relate to the manufacture, shipment, storage, security, inventory, recordkeeping, distribution, sale, dispensing, and use of controlled substances. The DEA and other regulatory agencies limit the availability of the controlled substances used in certain of the company’s products and products in development. The company must annually, as well as quarterly, apply to the DEA and similar governmental and regulatory authorities for procurement quotas in order to obtain these substances.
History
The company was founded in 2002. It was formerly known as Atlas Holdings, Inc. and changed its name to Amneal Pharmaceuticals, Inc. in 2018.
