Takeda Pharmaceutical Company Limited (Takeda) operates as a patient-focused, values-based, research and development (R&D)-driven global biopharmaceutical company with a diverse portfolio, engaged primarily in the research, development, production and global commercialization of biopharmaceutical products.
The company’s intent is to translate science into highly innovative, life-transforming medicines. The company has built an R&D engine focused on three core therapeutic areas, leveraging inter...
Takeda Pharmaceutical Company Limited (Takeda) operates as a patient-focused, values-based, research and development (R&D)-driven global biopharmaceutical company with a diverse portfolio, engaged primarily in the research, development, production and global commercialization of biopharmaceutical products.
The company’s intent is to translate science into highly innovative, life-transforming medicines. The company has built an R&D engine focused on three core therapeutic areas, leveraging internal research and external partners in order to have access to different modalities, such as biologics or small molecules. The company has a geographically diversified global business base, and its prescription drugs are marketed worldwide.
Takeda's business is grouped into six key business areas: Gastroenterology (‘GI’), Rare Diseases, Plasma-Derived Therapies (‘PDT’), Oncology, Vaccines, and Neuroscience. The company’s R&D efforts focus on three core therapeutic areas: Gastrointestinal and Inflammation, Neuroscience, and Oncology. The company also makes targeted R&D investments in PDT. The company focuses on developing innovative medicines that make a difference in people’s lives by advancing the frontier of new treatment options and leveraging its collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. The company focuses on high unmet medical needs, both in rare and more prevalent conditions, to deliver high-quality medicines to patients and communities as quickly as possible. The company has a presence in approximately 80 countries and regions, a network of manufacturing sites around the world, primarily in the United States, Europe, Japan, and Singapore, and major research centers in Japan and the United States. Commercially, the company has a very significant presence in the United States, Japan, and Europe, as well as a fast-growing business in China.
As of March 31, 2025, the following Growth & Launch Products were the company’s growth driver products in its key business areas: ENTYVIO, EOHILIA, TAKHZYRO, LIVTENCITY, ADZYNMA, Immunoglobulin products (including GAMMAGARD LIQUID/KIOVIG, HYQVIA, and CUVITRU), Albumin products (including HUMAN ALBUMIN/FLEXBUMIN), FRUZAQLA, ALUNBRIG, and QDENGA.
The company’s R&D engine is focused on translating science into highly innovative, life-transforming medicines that make a critical difference to patients. Takeda supports dedicated R&D efforts across three areas: Innovative Biopharma, Plasma-Derived Therapies (PDT), and Vaccines. The R&D engine for Innovative Biopharma is the largest component of its R&D investment and has produced exciting new molecular entities (‘NMEs’) that represent potential best-in-class and/or first-in-class medicines in areas of high unmet medical need, both in rare and more prevalent conditions, across its core therapeutic areas (gastrointestinal and inflammation, neuroscience, and oncology). Takeda is committed to both rare and more prevalent diseases, and many of the life-transforming medicines it is pursuing will treat rare diseases in its core therapeutic areas, as well as in PDT. The company is working to harness the potential of cell therapies by investing in new capabilities and next-generation platforms internally and through a network of partnerships. The company is embracing data and digital technologies with the aim of improving the quality of innovation and accelerating execution.
The company is also focused on its goals of optimizing its financial strength, delivering competitive margins, and generating cash flows to invest in the business, to maintain a solid investment-grade credit rating, and to return cash to shareholders. In addition to these improvements, the company also seeks to improve operational efficiency across its organization through implementing transformational initiatives. On May 9, 2024, the company announced a multi-year, enterprise-wide efficiency program aimed at promoting business growth and improving its profitability. This program includes increasing the agility and simplicity of its business organization, investing in digital, data, and technology to enhance productivity and efficiency across the organization, and implementing cost reductions and process improvements in supply chain and vendor management.
The following is a summary of the company’s principal products by business area.
In GI, the company’s principal products include:
ENTYVIO (vedolizumab), a treatment for moderate to severe ulcerative colitis and Crohn’s disease. Sales of ENTYVIO have grown strongly since its launch in the U.S. and Europe in 2014, and it was its top-selling product in the fiscal year ended March 31, 2025. ENTYVIO is now approved in more than 70 countries worldwide, with a subcutaneously administered formulation approved in the U.S., Europe, and Japan. The company strives to maximize its potential by seeking approval in additional countries, examining use in further indications.
EOHILIA (budesonide oral suspension), a therapy for eosinophilic esophagitis (EoE). EOHILIA is a corticosteroid, and the first and only FDA-approved oral therapy indicated for 12 weeks of treatment in patients 11 years and older with EoE. EOHILIA was approved by the U.S. FDA in February of 2024 and subsequently launched.
TAKECAB/VOCINTI (vonoprazan fumarate), a treatment for acid-related diseases. TAKECAB was launched in Japan in 2015 and has achieved significant growth driven by its efficacy in reflux esophagitis and the prevention of recurrence of gastric and duodenal ulcers during low-dose aspirin administration. TAKECAB (Chinese brand name: VOCINTI) was approved for reflux esophagitis in 2019 in China.
GATTEX/REVESTIVE (teduglutide [rDNA origin]), a treatment for patients with short bowel syndrome (SBS) who are dependent on parenteral support. GATTEX/REVESTIVE has been launched in the U.S., Europe, and Japan with adult and pediatric indications.
In Rare Diseases, the company’s principal products are:
TAKHZYRO (lanadelumab-flyo), for the prevention of hereditary angioedema (HAE) attacks. TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein, an enzyme that is chronically uncontrolled in people with HAE. TAKHZYRO was approved for patients 12 years and older in both the U.S. and Europe in 2018, in China in 2020, and in Japan in 2022, and the company is working to expand into further geographic areas. In 2023, TAKHZYRO was also approved by the FDA and the European Commission in patients aged 2 years and older, and in February 2025, an additional 2 mL pre-filled pen option for the product was approved by the European Medicines Agency (EMA) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with hereditary angioedema.
LIVTENCITY (maribavir), a treatment for adults and pediatric patients (12 years and older and weighing at least 35 kg) for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, foscarnet, or cidofovir. LIVTENCITY launched in the U.S. in December 2021, and was approved in Europe in November 2022, and China in December 2023. LIVTENCITY continues to show strong launch performance driven by fast uptake, rapid geographic expansion, and positive market access trends indicating high unmet medical needs.
ADZYNMA (ADAMTS13, recombinant-krhn), a prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). ADZYNMA is the first and only FDA-approved recombinant ADAMTS13 (rADAMTS13) designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme. ADZYNMA (apadamtase alfa/cinaxadamtase alfa) has now also been approved in Japan for the treatment of cTTP for individuals 12 years and older, and in Europe (EMA markets) for individuals of all ages.
ELAPRASE (idursulfase), an enzyme replacement therapy for the treatment of Hunter syndrome (also known as Mucopolysaccharidosis Type II or MPS II).
REPLAGAL (agalsidase alfa), an enzyme replacement therapy for the treatment of Fabry disease, marketed outside of the U.S., and also approved in China in 2020. Additionally, Takeda has acquired the manufacturing and marketing approval and the marketing rights of REPLAGAL in Japan from Sumitomo Dainippon Pharma as of February 2022. Fabry disease is a rare, inherited genetic disorder resulting from a deficiency in the activity of the lysosomal enzyme alpha-galactosidase A, which is involved in the breakdown of fats.
ADVATE (antihemophilic factor (recombinant)), a treatment for hemophilia A (congenital factor VIII deficiency) for control and prevention of bleeding episodes, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ADYNOVATE/ADYNOVI (antihemophilic factor (recombinant) [PEGylated]), an extended half-life recombinant factor VIII treatment for hemophilia A. ADYNOVATE/ADYNOVI uses the same manufacturing process as the standard half-life recombinant factor VIII therapy ADVATE and adds a proven technology, PEGylation (a chemical process that prolongs the amount of time a compound remains in circulation, potentially allowing for fewer injections), which the company exclusively licensed from Nektar Therapeutics.
VPRIV (velaglucerase alfa), is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.
In Plasma-Derived Therapies (PDT), the company’s principal products are:
GAMMAGARD LIQUID/KIOVIG (Immune Globulin Intravenous (Human) 10%), a liquid formulation of the antibody replacement therapy immunoglobulin (IG), for the treatment of adult and pediatric patients two years and older with primary immunodeficiencies (PID) (administered either intravenously or subcutaneously), and adult patients with multifocal motor neuropathy (MMN) (administered intravenously). GAMMAGARD LIQUID was approved for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S. in January 2024. KIOVIG is the brand name used for GAMMAGARD LIQUID in many countries outside of the U.S.; KIOVIG is approved in Europe for multiple indications, including CIDP.
HYQVIA (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), a product consisting of human normal IG and recombinant human hyaluronidase (licensed from Halozyme). HYQVIA is the only subcutaneous IG treatment for PID patients with a dosing regimen that requires only one infusion up to once per month and one injection site per infusion to deliver a full therapeutic dose of IG. HYQVIA is approved in the U.S. for adults with PID, in Europe for patients with PID syndromes and myeloma or CLL with severe secondary hypogammaglobulinemia and recurrent infections, and in Japan for patients with PID or secondary immunodeficiency (SID) with agammaglobulinemia or hypogammaglobulinemia. In January 2024, HYQVIA was approved for maintenance treatment in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S. and CIDP patients of all ages in Europe.
CUVITRU (Immune Globulin Subcutaneous (Human), 20% Solution), indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years and older. CUVITRU is also indicated in Europe for the treatment of certain secondary immunodeficiencies. CUVITRU is the only 20% subcutaneous IG treatment option without proline and with the ability to infuse up to 60 mL (12 grams) per site and 60 mL per hour, per site as tolerated, resulting in fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments.
In the fiscal year ended March 31, 2025, the total revenue from the company’s PDT immunology portfolio, including GAMMAGARD LIQUID/KIOVIG, HYQVIA, and CUVITRU, was JPY 757.8 billion.
FLEXBUMIN (Human Albumin in a bag) and Human Albumin (glass), available as 5% and 25% solutions, indicated for hypovolemia, hypoalbuminemia due to general causes and burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime. FLEXBUMIN 25% is also indicated for hypoalbuminemia associated with adult respiratory distress syndrome (ARDS) and nephrosis, and hemolytic disease of the newborn (HDN).
In Oncology, the company’s principal products include:
ALUNBRIG (brigatinib), an orally administered small molecule anaplastic lymphoma kinase (‘ALK’) inhibitor used to treat ALK-positive non-small cell lung cancer (NSCLC), was granted accelerated approval for patients who have progressed on or are intolerant to crizotinib in the U.S. in 2017, and marketing authorization for patients previously treated with crizotinib in the EU in 2018. The indication of ALUNBRIG was expanded to include newly diagnosed ALK-positive NSCLC patients in both the U.S. and the EU in 2020. ALUNBRIG was approved as a first and second-line therapy in Japan in January 2021. ALUNBRIG was also approved in China in March 2022.
FRUZAQLA (fruquintinib), a treatment for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is approved in the U.S., EU, Japan, and a number of other countries around the world as a selective oral inhibitor of all three VEGF receptors. The company has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau. Fruquintinib is developed and marketed in China by HUTCHMED.
LEUPLIN/ENANTONE (leuprorelin), a treatment for hormone-responsive cancers, such as prostate cancer or breast cancer in women, as well as children with central precocious puberty, women with endometriosis and infertility, and to improve anemia in women with uterine leiomyomata (fibroids). While leuprorelin is no longer protected by patent, there is limited generic competition due to manufacturing considerations.
NINLARO (ixazomib), the first oral proteasome inhibitor for the treatment of multiple myeloma (MM), was approved in the U.S. in 2015 for relapsed/refractory MM and was approved in Europe in 2016, in Japan in 2017, and in China in 2018. In Japan, NINLARO is also approved as a maintenance treatment for MM.
ADCETRIS (brentuximab vedotin), an anti-cancer agent used to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), has received marketing authorization in more than 70 countries worldwide and was approved in China in May 2020. Takeda jointly developed ADCETRIS with Seagen Inc., now a wholly owned subsidiary of Pfizer Inc. (‘Pfizer’), and has commercialization rights in countries outside the U.S. and Canada.
ICLUSIG (ponatinib), a tyrosine kinase inhibitor targeting BCR::ABL1 with indications across chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), received full approval in the U.S. in 2016 and subsequent U.S. approvals in expanded indications in 2020 and 2024. The company has commercialization rights in the U.S. and Australia. Outside of the U.S. and Australia, ICLUSIG is marketed in over 60 markets by five authorized partners from whom Takeda receives varying levels of supply, royalty, and milestone payments.
In Neuroscience, the company’s principal products are:
VYVANSE/ELVANSE (lisdexamfetamine dimesylate), a stimulant medication indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients six years and older and for the treatment of moderate to severe binge eating disorder in adults. Sales declined in the U.S. since 2023, following the entry of generic competition.
TRINTELLIX (vortioxetine), an antidepressant indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX was co-developed with H. Lundbeck A/S, and Takeda has commercialization rights in the U.S., where it was launched in 2014, and in Japan, where it was launched in 2019.
In Vaccines, the company’s principal product is:
QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]), a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic ‘backbone’ for all four dengue virus serotypes and is designed to protect against any of these serotypes. QDENGA is available in 29 countries, including endemic countries and travel markets.
Research and Development
The company’s research and development expenses for the fiscal year ended March 31, 2025, were JPY 730.2 billion.
Gastrointestinal and Inflammation
In Gastrointestinal and Inflammation, Takeda focuses on delivering innovative, life-changing therapeutics for patients with gastrointestinal diseases (including those of the liver), as well as immune-mediated inflammatory diseases. The company is maximizing the potential of its inflammatory bowel disease (IBD) franchise around ENTYVIO, including the introduction of a subcutaneous formulation and running real-world evidence generation studies that demonstrate ENTYVIO’s place as a backbone therapy in the IBD treatment paradigm and further its understanding of how to improve outcomes for patients. Zasocitinib (TAK-279) is a next-generation oral tyrosine kinase 2 (TYK2) inhibitor with potential to treat multiple immune-mediated inflammatory diseases. Fazirsiran (TAK-999) is a potential first-in-class RNAi treatment for alpha-1 antitrypsin deficiency associated liver disease in late-stage development. Mezagitamab (TAK-079) is a potential best-in-class anti-CD38 antibody with disease-modifying potential for multiple immune-mediated diseases, such as ITP and IgA Nephropathy. Furthermore, Takeda is making progress on its pipeline built through in-house discovery, partnerships, and business development, which explores opportunities in inflammatory diseases (specifically in gastric, dermatological, and rheumatic disorders, along with select rare hematological and renal disorders (ADZYNMA, mezagitamab (TAK-079)), liver diseases, and neurogastric disorders.
Neuroscience
In Neuroscience, the company is focusing its R&D investments on potentially transformative treatments for neurological and neuromuscular diseases of high unmet need, and building its innovative pipeline by leveraging internal expertise and external collaborations. Takeda Neuroscience’s core focus is orexin biology, rare neurology, and neurodegeneration diseases. The company is advancing a portfolio of tailored therapies designed to unlock the full power of orexin (i.e., oveporexton (TAK-861), TAK-360) to redefine the standard of care for people living with rare sleep-wake disorders and other conditions where orexin biology is implicated. Across the company’s portfolio, it is harnessing advances in disease biology understanding, translational tools, innovative modalities, and digital innovation to accelerate development and patient access.
Oncology
In oncology, the company is committed to ensuring that patients globally can benefit from and access its portfolio of medicines, while also making progress on a pipeline of potential treatments for the future. The company’s research and development efforts are focused on three disease areas and four modalities. The company is advancing medicines for thoracic, gastrointestinal, and hematologic cancers. Within hematologic cancers, it is growing a portfolio of medicines for myeloid cancers, including rusfertide (TAK-121) and elritercept (TAK-226). The company’s core modalities include antibody drug conjugates (ADCs), complex biologics, small molecules, and gamma delta T cell therapies.
Other Rare Diseases programs
Takeda’s R&D engine is focused on areas of high unmet medical need, both in rare and more prevalent conditions, across three core therapeutic areas (gastrointestinal and inflammation, neuroscience, and oncology). In other Rare Diseases programs, the company focuses on several areas of high unmet medical need, on top of marketed products, such as TAKHZYRO in hereditary angioedema. In rare hematology, Takeda focuses on addressing today’s needs in the treatment of bleeding disorders, including through ADVATE and ADYNOVATE/ADYNOVI. In addition, the company aims to redefine the management of post-transplant cytomegalovirus (CMV) infection/disease with LIVTENCITY. Takeda commits to fulfilling the company’s vision to deliver life-transforming medicines to patients with rare diseases.
Plasma-Derived Therapies (PDT)
Takeda has created a dedicated PDT business unit with a focus on managing the business end-to-end, from plasma donation to manufacturing, R&D, and commercialization. In PDT, the company aspires to develop life-saving plasma-derived therapies, which are essential for patients with a variety of rare and complex chronic diseases. The dedicated R&D organization within PDT is charged with maximizing the value of existing therapies, identifying new targeted therapies, and optimizing efficiencies across the PDT value chain, from plasma donation to product manufacturing. Near-term, the company’s priority is focused on delivering value from its broad immunoglobulin portfolio (HYQVIA, CUVITRU, GAMMAGARD LIQUID, and GAMMAGARD S/D) through the pursuit of new indications, geographic expansions, and enhanced patient experience through integrated healthcare technologies. Additionally, the company is developing next-generation immunoglobulin products with 20% facilitated SCIG (TAK-881) and liquid low IgA IG (TAK-880), and is pursuing other early-stage opportunities (e.g., hypersialylated Immunoglobulin (hsIgG)) that would add to its diversified commercial portfolio of more than 20 therapeutic products distributed worldwide.
Vaccines
In Vaccines, Takeda is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue (QDENGA) and COVID-19 (NUVAXOVID). To support the expansion of the company’s pipeline and the development of its programs, it has entered into partnerships with government organizations in Japan and leading global institutions, including WHO (World Health Organization), PAHO (Pan American Health Organization), and Gavi (Global Alliance for Vaccines and Immunization), among others.
Manufacturing
The manufacturing of the company’s products is highly regulated by governmental health authorities around the world, including the U.S. FDA, EMA, Japan’s Pharmaceuticals and Medical Devices Agency (‘PMDA’), and NMPA.
Sales and Marketing
The company’s primary sales and marketing activities are organized around regional business units and select therapeutic area business units focused on the U.S., Japan, Europe and Canada, China, and Growth and Emerging Markets. These business units make focused investments that support the growth potential of its portfolios in each market.
The U.S. is the largest pharmaceutical market in the world and is also Takeda’s largest region by revenue. The United States Business Unit (‘USBU’) is focused on the successful launch of a subcutaneous administration of ENTYVIO (ENTYVIO Pen), approved for ulcerative colitis in September 2023 and Crohn’s disease in April 2024, EOHILIA, approved in February 2024, and the expanded indications for HYQVIA and GAMMAGARD LIQUID in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) approved in January 2024. In addition, core promoted products, such as TRINTELLIX, GATTEX, and TAKHZYRO will contribute to the growth, as being supported by significant investment in the marketing and sales force promotion.
The Japan Pharma Business Unit (‘JPBU’) is focused on retaining Takeda’s position as one of the leading pharmaceutical companies in the company’s home market of Japan. Although the company continues to promote its strong primary care portfolio, with the Japanese government driving stricter control of drug prices and promoting the penetration of generics, its strategy is to shift focus more towards the uptake of its highly innovative and differentiated specialty medicines, such as ENTYVIO, GATTEX/REVESTIVE, TAKECAB, TRINTELLIX, and TAKHZYRO. Furthermore, four new products—ADZYNMA, OBIZUR, LIVTENCITY, and CEPROTIN—were launched in FY2024, along with the introduction of a new 2-dose vial of NUVAXOVID for Omicron JN.1, to further drive revenue growth.
The Global Portfolio Division (‘GPD’) is focused on accelerating the company’s growth through a global footprint, as well as a diverse portfolio and pipeline of transformational medicines and vaccines. The GPD comprises the China, EUCAN, GEM, and Global Vaccine Business Units, and the Global Medical and Global Product & Launch Strategy (‘GPLS’) functions.
The Europe and Canada (‘EUCAN’) business unit focuses on a specialized approach in the European and Canadian markets, where public insurance has set a high bar for the reimbursement of medicines, requiring innovation and clear differentiation in order for products to be reimbursed. The EUCAN business unit is focused on continuing to grow core products, such as ENTYVIO, TAKHZYRO, ELVANSE/VYVANSE, and the company’s immunoglobulin products, and recently approved products such as LIVTENCITY.
The China Business Unit (‘China BU’) focuses on unleashing the growth potential in the world’s second-largest pharmaceutical market. The China BU continues to maximize the value of brands, such as ENTYVIO, ADCETRIS, TAKHZYRO, REPLAGAL, ALUNBRIG, LIVTENCITY, and HUMAN ALBUMIN/FLEXBUMIN, while also aiming to bring more new medicines and treatment options to China in the future from the therapeutic areas of Gastrointestinal and Inflammation, Neuroscience, Oncology, and Rare Genetics and Hematology.
The Growth and Emerging Markets (‘GEM’) Business Unit is focused on delivering highly innovative medicines to patients in GEM countries living with complex and rare diseases in the company’s six key business areas of GI, Rare Diseases, PDT, Oncology, Vaccines, and Neuroscience.
The Oncology Business Unit (‘OBU’) is focused on the development and marketing of oncology medicines in the U.S., Japan, Europe, and Canada. The company’s promoted oncology portfolio consists of three global brands (ALUNBRIG, NINLARO, and FRUZAQLA), as well as products that it markets on a regional basis, including ICLUSIG in the U.S., ADCETRIS in markets outside of the U.S. and Canada, and VECTIBIX, ZEJULA, and CABOMETYX in Japan.
The PDT Business Unit is focused on transforming the lives of patients from the collection of plasma to the production and delivery of life-saving medicines worldwide. The company offers a broad portfolio of greater than twenty therapies, four of which represent Global Brands for Takeda, HYQVIA and CUVITRU, subcutaneous immunoglobulin, KIOVIG/GAMMAGARD LIQUID, intravenous immunoglobulin, and FLEXBUMIN, the company’s differentiated bag Albumin product.
The Global Vaccine Business Unit (‘GVBU’) is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue (QDENGA), pandemic influenza, and COVID-19 through a partnered program in Japan with Novavax, Inc.
Licensing and Collaboration
ADCETRIS: The company entered into a Collaboration Agreement with Pfizer Inc. (‘Pfizer’) (as successor in interest to Seagen, Inc., which was acquired by Pfizer in December 2023) in 2009 for the global co-development of ADCETRIS and its commercialization around the world (other than the U.S. and Canada, where ADCETRIS is commercialized by Pfizer).
FRUZAQLA: The company entered into a License Agreement with HUTCHMED Limited (‘HUTCHMED’) in 2023 for the global development, commercialization, and manufacture of fruquintinib outside of mainland China, Hong Kong, and Macau. FRUZAQLA is now approved in the U.S., EU, Japan, and a number of other countries in the company’s licensed territory.
TRINTELLIX: The company entered into a License, Development, Supply, and Commercialization Agreement with H. Lundbeck A/S in 2007 for the exclusive co-development and co-commercialization in the U.S. and Japan of several compounds in Lundbeck’s pipeline for the treatment of mood and anxiety disorders. In July 2024, Lundbeck announced the company’s agreement to amend the collaboration to provide for royalty payments by Takeda to Lundbeck based on net sales of TRINTELLIX in the U.S. in lieu of Lundbeck’s co-promotion and co-funding responsibilities, which have concluded.
Competition
The following shows the principal sources of competition for the company’s main products:
GI:
DEXILANT, PANTOPRAZOLE (Protonix): Pfizer, AstraZeneca, and Procter and Gamble.
ENTYVIO: Janssen Biotech, AbbVie, Pfizer, Eli Lilly and Company, Amgen, Organon, BMS, Alphasigma/Galapagos, EA Pharma, Celltrion, UCB, and Johnson & Johnson.
EOHILIA: Regeneron / Sanofi, and Dr. Falk Pharma.
GATTEX/REVESTIVE
TAKECAB: AstraZeneca.
ADVATE and ADYNOVATE: Pfizer, Sobi, Bayer, Sanofi, Novo Nordisk, Octapharma, CSL, Bayer, Roche, Biomarin, and Grifols.
ADZYNMA: Octapharma, Kedrion, and Bio Products Laboratory.
ELAPRASE: Korean Green Cross, and JCR Pharmaceuticals.
FEIBA: Roche, Novo Nordisk, and Sanofi.
LIVTENCITY: Merck/MSD.
REPLAGAL: Sanofi Genzyme, Amicus, Isu Abxis, and Chiesi.
TAKHZYRO: Pharming, BioCryst, and CSL.
VPRIV: Sanofi Genzyme, Pfizer/Protalix, Actelion [Janssen], Sanofi Genzyme, and Isu Abxis.
PDT Immunology
FLEXBUMIN and HUMAN ALBUMIN: CSL, Grifols, Octapharma, and Kedrion.
GAMMAGARD LIQUID, HYQVIA, CUVITRU: CSL, Grifols, Octapharma, Argenx, ADMA, Kedrion, and BPL.
Oncology
ADCETRIS: Merck/MSD, and Bristol-Myers Squibb.
ALUNBRIG: Pfizer, Novartis, Roche, and Xcovery.
FRUZAQLA: Taiho Pharmaceutical Co., and Bayer.
ICLUSIG: Novartis, Bristol-Myers Squibb, and Pfizer.
LEUPRORELIN (LEUPLIN): AstraZeneca, Recordati, Ferring, Sumitomo, Accord Healthcare, and Accord BioPharma.
NINLARO: Bristol-Myers Squibb, Amgen, Janssen Biotech, Karyopharm, Sanofi, GSK, Janssen, and Pfizer.
Neuroscience
ADDERALL XR: Tris Pharma, Corium, Janssen Pharmaceuticals, Ironshore Pharmaceuticals, and Purdue Pharma.
INTUNIV: Eli Lilly and Company, and Supernus.
TRINTELLIX: AbbVie, and Axsome.
VYVANSE: Tris Pharma, Corium, Janssen Pharmaceuticals, Ironshore Pharmaceuticals, Purdue Pharma, Tris Pharma, Eli Lilly and Company, Shionogi, and Supernus.
Vaccines
QDENGA: Sanofi Pasteur.
Regulation
Takeda must pay rebates on purchases of the company’s products under the Medicaid Drug Rebate Program.
Takeda must also calculate and report specific prices to government agencies, including the ASP used by the Medicare Part B program.
Takeda must offer discounted pricing for purchases by certain designated health care entities and federal agencies under certain federal programs, including the Public Health Service (the ‘PHS’) pharmaceutical pricing program (‘340B’) and the Federal Supply Schedule (the ‘FSS’).
History
Takeda Pharmaceutical Company Limited was founded in 1781. The company was incorporated in Japan under the Companies Act of Japan in 1925.
