Teva Pharmaceutical Industries Limited (Teva) develops, manufactures, markets, and distributes generics, innovative medicines and biopharmaceutical products in the United States and Europe.
Business Segments
The company operates through three segments: United States (previously referred to as the North America segment), Europe, and International Markets. Each business segment manages its entire product portfolio in its region, including generics, which includes biosimilars and over-the-counter...
Teva Pharmaceutical Industries Limited (Teva) develops, manufactures, markets, and distributes generics, innovative medicines and biopharmaceutical products in the United States and Europe.
Business Segments
The company operates through three segments: United States (previously referred to as the North America segment), Europe, and International Markets. Each business segment manages its entire product portfolio in its region, including generics, which includes biosimilars and over-the-counter (OTC) products, as well as innovative medicines. In addition to these three segments, the company has other activities, primarily the sale of active pharmaceutical ingredients (API) to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis.
United States
Canada is reported as part of the company's International Markets segment.
The company is one of the leading generic pharmaceutical companies in the United States. It markets approximately 500 generic prescription products in more than 1,400 dosage strengths, packaging sizes and forms, including oral solid dosage forms, injectable products, inhaled products, liquids, transdermal patches, ointments and creams. Most of its generic sales in the United States are made to retail drug chains, mail order distributors and wholesalers.
The company's innovative medicines portfolio in the United States includes its core therapeutic area of central nervous system (CNS), with a strong emphasis on neurodegenerative disorders, neuropsychiatry, movement disorders, migraine, and multiple sclerosis (MS). It also has innovative medicines in respiratory, oncology, and selected other areas.
The company's CNS portfolio includes AUSTEDO (deutetrabenazine) tablets for the treatment of neurodegenerative and movement disorders - chorea associated with Huntington's disease and tardive dyskinesia, AJOVY (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults, UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults, and COPAXONE (glatiramer acetate) injection for the treatment of relapsing forms of MS.
The company maintains a presence in oncology, including innovative, generic and biosimilar medicines, such as Truxima (rituximab-abbs) injection for intravenous use, its first oncology biosimilar product in the United States for the treatment of Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), and BENDEKA (bendamustine HCl), which is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride for the treatment of CLL and indolent B-cell NHL, that it licensed from Eagle Pharmaceuticals, Inc. (Eagle).
The company maintains a presence in the respiratory business by delivering a range of medicines for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
Anda, the company's distribution business in the United States, distributes generic, biosimilar and innovative medicines, and OTC pharmaceutical products from Teva and various third-party manufacturers, to independent retail pharmacies, pharmacy retail chains, hospitals, and physician offices in the United States. Anda is able to compete in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.
Europe
The company's Europe segment includes the European Union, the United Kingdom and certain other European countries.
The company is one of the leading generic pharmaceutical companies in Europe. It is among the top three generic pharmaceutical companies in a number of European markets, including some of the largest markets in Europe.
The company is one of a few generic pharmaceutical companies with a pan-European footprint, while most of its competitors focus on a limited number of selected markets or business lines.
The company's OTC portfolio in Europe includes global brands, such as SUDOCREM, as well as local and regional brands, such as NasenDuo, DICLOX FORTE, OLFEN Max, and FLEGAMINA.
The company's innovative medicines portfolio in Europe focuses on three main areas: CNS (including migraine), respiratory and oncology. Its leading products in Europe are AJOVY and COPAXONE. AJOVY was granted EU marketing authorization in 2019 and, as of December 31, 2024, the company has launched AJOVY in most European countries. COPAXONE continues to be among the primary products for the treatment of MS, although alternative therapies and competing glatiramer acetate products have been introduced to various markets in Europe. In line with its Pivot to Growth strategy, the company is constantly evaluating and optimizing its products portfolio, including through the sale of certain product rights in its Europe segment.
International Markets
The company's International Markets segment includes all countries in which it operates other than those in its United States and Europe segments. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada is reported under its International Markets segment.
The countries in the company's International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, branded generics-oriented markets, such as Russia and certain Latin America markets, and hybrid markets, such as Japan. The company's integrated sales force enables it to extract synergies across its branded generic, OTC, biosimilars and innovative medicines product offerings and across various channels (e.g., retail, institutional).
In Japan, one of the company's key markets within its International Markets segment, it operates its generics business through a business venture with Takeda Pharmaceutical Companies Limited (Takeda), in which it owns a 51% stake and Takeda owns the remaining 49%.
The company's innovative medicines portfolio in its International Markets segment focuses on three main areas: CNS (including migraine), respiratory and oncology. By the end of 2024, it launched AJOVY in certain countries within its International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil, and others. AUSTEDO was launched in China and Israel during 2021 and in Brazil in 2022.
Pivot to Growth Strategy
In 2024, the company continued to execute on the four key pillars of its 'Pivot to Growth' strategy, which it announced in May 2023.
On the first pillar, delivering on the company's growth engines, it continued to show strong performance of its key innovative products, mainly AUSTEDO, AJOVY, and UZEDY, as well as on its late-stage pipeline of biosimilars, with the launches of SIMLANDI (adalimumab-ryvk) injection and the expected launch of SELARSDI (ustekinumab-aekn) injection, and the progress it made on its proposed biosimilars to Prolia, Simponi, and Simponi Aria which were submitted for regulatory review in the U.S. and the EU;
On the second pillar, stepping up innovation through delivering on its late-stage innovative pipeline, it has been accelerating the development of certain key pipeline assets, including the recent positive Phase 2b results for duvakitug (anti-TL1A), and expect a number of milestones and data points for olanzapine LAI and DARI (Dual-action Asthma Rescue Inhaler, ICS/SABA) in the near future;
On the third pillar, sustaining its generic medicines powerhouse with a global commercial footprint, focused portfolio, pipeline and manufacturing footprint, it continued to optimize its generics business and build a strong pipeline of biosimilars, with several successful launches of high-value complex generics in 2024; and
Lastly, on the company's fourth pillar, focusing its business by optimizing its portfolio and global manufacturing footprint.
Product Portfolio and Business Offering
The company's product and service portfolio, including generic medicines, biosimilar medicines, innovative medicines, OTC products, a distribution business, API and contract manufacturing. Each region manages the entire range of products and services offered in its area, and its generics, biosimilars, OTC and innovative franchise units optimize its pipeline and product lifecycle across therapeutic areas. In most markets in which the company operates, it uses an integrated and comprehensive marketing model, offering a broad portfolio of products, including innovative medicines, generic products, biosimilars and OTC products. As part of its Pivot to Growth strategy, the company intends to divest its API business, in order to focus on its core business strengths.
Generic Medicines
Generic medicines are the chemical and therapeutic equivalents of originator medicines and are typically more affordable in comparison to the originator's products. Generic medicines are required to meet similar governmental requirements as their brand-name equivalents, such as those relating to current Good Manufacturing Practices (cGMP), manufacturing processes and health authorities' inspections, and must receive regulatory approval prior to their sale in any given country. Generic medicines may be manufactured and marketed if relevant patents on their brand-name equivalents (and any additional government-mandated market exclusivity periods) have expired or have been challenged or otherwise circumvented.
The company develops, manufactures, and sells generic medicines in a variety of dosage forms, including tablets, capsules, injectables, inhalants, liquids, transdermal patches, ointments, and creams. It offers a broad range of basic chemical entities, as well as specialized product families, such as sterile products, hormones, high-potency drugs and cytotoxic substances, in both parenteral and solid dosage forms. It also offers generic products with medical devices and combination products.
The company's generics business has a wide-reaching commercial presence. It has a top three leadership position in many countries, including the United States and some key European markets. The company has a robust product portfolio, comprehensive R&D capabilities and product pipeline, and a global operational network, which enables it to execute key generic launches to further expand its product pipeline and diversify its revenue stream.
In recent years, the company launched the following biosimilar medicines: Truxima (rituximab-abbs) (U.S.: 2019; Canada: 2020), Herzuma (trastuzumab-pkrb) (U.S./Canada: 2020) and Ranivisio (ranibizumab) (EU/UK: 2022; Canada: 2023).
On February 24, 2024, Teva and Alvotech announced that the FDA approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. On May 21, 2024, Teva and Alvotech announced the availability of SIMLANDI in the U.S.
On April 16, 2024, Teva and Alvotech announced that the FDA approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older.
On January 10, 2025, the company announced that it entered into a strategic partnership with Samsung Bioepis for the commercialization of EPYSQLI (eculizumab), Samsung Bioepis' biosimilar to Soliris (eculizumab-aagh) in the U.S., for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG). Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration, manufacture and supply of the product, and Teva will be responsible for commercialization of the product in the U.S.
On January 13, 2025, the company announced that it entered into a collaboration agreement with Formycon for the commercialization of FYB203, Formycon's biosimilar candidate to Eylea (aflibercept) in Europe (excluding Italy), the United Kingdom, Switzerland and in Israel, for the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name AHZANTIVE, subject to regulatory approval.
Innovative Medicines
The company's innovative medicines business focuses on delivering innovative solutions to patients and providers via medicines, devices and services in key regions and markets around the world and includes its core therapeutic areas of CNS, with a strong emphasis on neurodegenerative disorders, neuropsychiatry, movement disorders, migraine, and MS. The company also has innovative medicines in respiratory, oncology, and selected other areas.
The company deploys medical and sales and marketing professionals within specific therapeutic areas who seek to address the needs of patients and healthcare professionals. It tailors its patient support, payer relations and medical affairs activities to the distinct characteristics of each therapeutic area and medicine.
The U.S. market is the most significant market in the company's innovative medicines business. In Europe and International Markets, it leverages existing synergies between its innovative medicines business and its generics and OTC businesses. The company's innovative medicines presence in International Markets is mainly built on its CNS, respiratory and oncology medicines.
The company has built specialized 'Patient Support Programs' to help patients adhere to their treatments, improve patient outcomes and, in certain markets, ensure timely delivery of medicines and assist in securing reimbursement. These programs reflect the importance the company places on supporting patients and ensuring better medical outcomes for them. Patient Support Programs are operated in many countries around the world in multiple therapeutic areas.
Below is a description of the company's key innovative medicines:
CNS (including Movement Disorders and Migraine)
The company's CNS portfolio includes AUSTEDO for the treatment of tardive dyskinesia and chorea associated with Huntington's disease, AJOVY for the preventive treatment of migraine, UZEDY for the treatment of schizophrenia, and COPAXONE for the treatment of relapsing forms of MS.
AUSTEDO
AUSTEDO (deutetrabenazine) tablets are a deuterated form of a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain. All regulatory exclusivities for AUSTEDO are expired.
AUSTEDO was launched in the U.S. in 2017. It is indicated for the treatment of chorea associated with Huntington's disease and for the treatment of tardive dyskinesia in adults, which is a debilitating, often irreversible movement disorder caused by certain medications used to treat mental health or gastrointestinal conditions. It is one of only two products approved for tardive dyskinesia in the U.S.
AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022. It continues with additional submissions in various other countries around the world.
AUSTEDO is protected in the United States by 14 Orange Book patents expiring between 2031 and 2038. The company received notice letters from two ANDA filers regarding the filing of their ANDAs with paragraph (IV) certifications for certain of the patents listed in the Orange Book for AUSTEDO. On April 29, 2022, and June 8, 2022, it reached agreements with Lupin and Aurobindo, respectively, to sell their generic products beginning in April 2033, or earlier under certain circumstances. In addition, Apotex filed a petition for inter partes review (IPR) by the Patent and Trial Appeal Board (PTAB) of the patent covering the deutetrabenazine compound that expires in 2031. On March 9, 2022, the U.S. Patent and Trademark Office denied Apotex's petition and declined to institute a review of the deutetrabenazine patent. In China, invalidity proceedings were initiated against the deutetrabenazine compound patent by a local Chinese pharmaceutical company and were discontinued following a settlement between the parties.
AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023, in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in 18 mg in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington's disease, which is additional to the marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.
AJOVY
AJOVY (fremanezumab-vfrm) injection is a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and is indicated for the preventive treatment of migraine in adults. AJOVY was launched in the U.S. in 2018.
During 2019, AJOVY was granted a marketing authorization in the European Union by the European Medicines Agency (EMA) in a centralized process and began receiving marketing authorizations in various countries in its International Markets segment. By the end of 2023, the company launched AJOVY in most European countries and in certain countries within its International Markets segment, such as Canada, Japan, Australia, Israel, South Korea, Brazil and others. It is moving forward with plans to launch in other countries around the world.
The company's auto-injector device for AJOVY became commercially available in the European Union in March 2020, in the U.S. in April 2020 and in Canada in April 2021. AJOVY is the only anti-CGRP subcutaneous product indicated for quarterly treatment. AJOVY faces competition from multiple other products.
AJOVY is protected worldwide by patents expiring in 2026 at the earliest; extensions have been granted in several countries, including the United States and in Europe, until 2031. Additional patents relating to the use of AJOVY in the treatment of migraine have also been issued in the United States and will expire between 2035 and 2039. Such patents are also pending in other countries. AJOVY will also be protected by regulatory exclusivity for 12 years from marketing approval in the United States (obtained in September 2018) and 10 years from marketing approval in Europe (obtained in April 2019).
In October 2017, the company filed a lawsuit in the U.S. District Court for the District of Massachusetts alleging that Eli Lilly & Co.'s (Lilly) marketing and sale of its galcanezumab product for the treatment of migraine infringes nine Teva patents, including three method of treatment patents and six composition of matter patents. Lilly then submitted IPR petitions to the PTAB, challenging the validity of the nine Teva patents. The PTAB issued decisions upholding the three method of treatment patents but finding the six composition of matter patents invalid, which decisions were affirmed by the Court of Appeals for the Federal Circuit on August 16, 2021. A jury trial regarding the three method of treatment patents resulted in a verdict in Teva's favor on November 9, 2022, in which the three method of treatment patents were determined to be valid and infringed by Lilly, and Teva was awarded damages. On September 26, 2023, the U.S. District Court for the District of Massachusetts issued a decision that reversed the jury's verdict and damages award, finding Teva's method of treatment patents to be invalid. Teva appealed this ruling on October 24, 2023, and the matter is fully briefed.
In addition, in 2018 the company entered into separate agreements with Alder Biopharmaceuticals, Inc. and Lilly resolving the European Patent Office oppositions that they filed against its AJOVY patents. The settlement agreement with Lilly also resolved Lilly's action to revoke the patent protecting AJOVY in the United Kingdom.
UZEDY
UZEDY (risperidone) extended-release injectable suspension was approved by the FDA on April 28, 2023 for the treatment of schizophrenia in adults, and was launched in the U.S. in May 2023. UZEDY is a subcutaneous, long-acting formulation of risperidone that controls the steady release of risperidone. UZEDY is protected by four Orange Book patents expiring between 2027 and 2040. UZEDY is protected by regulatory exclusivity until April 28, 2026. The company is moving forward with plans to launch UZEDY in other countries around the world. UZEDY faces competition from multiple other products.
COPAXONE
COPAXONE (glatiramer acetate injection) continues to play an important role in the treatment of MS in the United States (according to IQVIA data as of late 2023) and in Europe. COPAXONE is indicated for the treatment of patients with relapsing forms of MS (RMS), including the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis (RRMS), including in patients who have experienced a first clinical episode and have MRI features consistent with MS.
COPAXONE is believed to have a unique mechanism of action that works with the immune system, unlike many therapies that are believed to rely on general immune suppression or cell sequestration to exert their effect. COPAXONE provides a proven mix of efficacy, safety and tolerability.
In certain European countries, Teva remains in litigation against generic companies regarding COPAXONE.
The market for MS treatments continues to develop, particularly with the approval of generic versions of COPAXONE. Oral branded and generic treatments for MS, such as Tecfidera (generic: Dimethyl) and Gilenya (generic: Fingolimod) continue to significant and increasing competition. COPAXONE also continues to face competition from existing injectable products, as well as from monoclonal antibodies, such as Ocrevus, Kesimpta, and Tysabri.
Oncology
The company's innovative oncology medicines portfolio mainly includes BENDEKA and TREANDA in the United States.
BENDEKA and TREANDA
BENDEKA (bendamustine hydrochloride) injection and TREANDA (bendamustine hydrochloride) injection are approved in the United States for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) and patients with indolent B-cell Non-Hodgkin's Lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The company launched BENDEKA in the United States in January 2016. It is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride that it licensed from Eagle.
BENDEKA faces direct competition from Belrapzo (a ready-to-dilute bendamustine hydrochloride product from Eagle) and from Vivimusta. Other competitors to BENDEKA include combination therapies, such as R-CHOP (a combination of cyclophosphamide, vincristine, doxorubicin and prednisone in combination with rituximab) and CVP-R (a combination of cyclophosphamide, vincristine and prednisolone in combination with rituximab) for the treatment of NHL, as well as a combination of fludarabine, doxorubicin and rituximab for the treatment of CLL and newer targeted oral therapies, such as ibrutinib, idelilisib and venetoclax. The orphan drug exclusivity that had attached to bendamustine products expired in December 2022.
In April 2019, the company signed an amendment to the license agreement with Eagle extending the royalty term applicable to the United States to the full period for which it sells BENDEKA and increased the royalty rate. In consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses.
There are 18 patents listed in the U.S. Orange Book for BENDEKA with expiration dates in 2026 and 2031. In August 2021, the Court of Appeals for the Federal Circuit affirmed the district court's decision upholding the validity of all the asserted patents and finding infringement by two remaining ANDA filers. Teva also settled with two ANDA filers.
Teva also settled litigation against three 505(b)(2) applicants, Hospira, Inc. (Hospira), Dr. Reddy's Laboratories (DRL) and Accord Healthcare (Accord). Based on these settlement agreements, Hospira, Accord and DRL can launch their products on November 17, 2027, or earlier under certain circumstances. In 2023, Teva and Eagle also filed suit against BendaRx Corp. in the U.S. District Court for the District of Delaware, following its filing of a 505(b)(2) NDA for a bendamustine product, and that litigation is still pending.
In addition to the settlement with Eagle regarding its bendamustine 505(b)(2) NDA, between 2015 and 2020, the company reached final settlements with 22 ANDA filers for generic versions of the lyophilized form of TREANDA and one 505(b)-(2) NDA filer for a generic version of the liquid form of TREANDA, providing for the launch of generic versions of TREANDA prior to patent expiration. There are multiple generic TREANDA products on the market.
Respiratory
The company's respiratory portfolio includes rescue and maintenance inhalers in treatment classes that are most commonly used for patients with asthma and COPD. The list of products includes ProAir RespiClick, QVAR Redihaler, BRALTUS, CINQAIR/CINQAERO, DuoResp Spiromax, and AirDuo RespiClick.
QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a BAI, is indicated for the maintenance treatment of asthma as a prophylactic therapy in patients four years of age and older. In January 2024, Teva received notice of a Paragraph IV challenge to the QVAR RediHaler patents from an ANDA filer for the 40mcg/inhalation strength. In September 2024, Teva received notice of a Paragraph IV challenge to the QVAR RediHaler patents from an ANDA filer for the 80mcg/inhalation strength. Teva filed suits against the ANDA filer in the U.S. District Court for the District of New Jersey and these litigations are pending.
BRALTUS (tiotropium bromide) is a long-acting muscarinic antagonist, indicated for adult patients with COPD, delivered via the Zonda inhaler. It was launched in Europe in August 2016.
CINQAIR/CINQAERO (reslizumab) injection is a humanized interleukin-5 antagonist monoclonal antibody for add-on maintenance treatment of adult patients with severe asthma and with an eosinophilic phenotype. This biologic treatment was launched in the U.S. and in certain European countries in 2016 and in Canada in 2017.
The company's portfolio of inhalers utilizing innovative multi-dose dry powder inhaler (MDPI) platform includes ProAir Respiclick (albuterol sulfate) inhalation powder and AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) in the U.S., as well as DuoResp Spiromax (budesonide and formoterol) in Europe.
Other Activities
The company has other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis.
The company produces approximately 350 APIs for its own use and for sale to third parties in many therapeutic areas. APIs used in pharmaceutical products are subject to regulatory oversight by health authorities. It utilizes a variety of production technologies, including chemical synthesis, semi-synthetic fermentation, enzymatic synthesis, high potency manufacturing, plant extract technology, peptide synthesis, vitamin D derivatives synthesis and steroids. The company's advanced technology and expertise in the field of solid state particle technology enable it to meet specifications for particle size distribution, bulk density, specific surface area and polymorphism, as well as other characteristics.
The company provides contract manufacturing services related to products divested in connection with the sale of certain business lines, as well as other miscellaneous items. Its other activities are not included in the United States, Europe and International Markets segments described above.
Biosimilar Products Pipeline
The company has additional biosimilar products in development internally and with its partners that are in various stages of clinical trials and regulatory review worldwide, including confirmatory clinical trials for biosimilars to Xgeva (denosumab), which was submitted for regulatory review in Europe, Xolair (omalizumab), the biosimilars to Eylea (aflibercept) and Entyvio (vedolizymab), which are in collaboration with Alvotech for the U.S. market, and a biosimilar in collaboration with mAbxience. Its proposed biosimilar to Prolia (denosumab) was submitted for regulatory review in the U.S. and Europe. The company's proposed biosimilars to Simponi and Simponi Aria (golimumab), which are in collaboration with Alvotech, were submitted for regulatory review in the U.S.
Pharmaceutical Production
The company operates 34 finished dosage and packaging pharmaceutical plants in 27 countries. These plants manufacture solid dosage forms, sterile injectables, liquids, semi-solids, inhalers, transdermal patches and other medicinal products. In 2024, it produced approximately 72 billion tablets and capsules, and approximately 547 million sterile units.
Research and Development
The company's net R&D expenses were $998 million for 2024.
Regulation
The company is committed to complying with global quality requirements and guidance by developing and manufacturing its products in accordance with Current Good Clinical Practices (CGCP), Current Good Laboratory Practices (CGLP), and Current Good Manufacturing Practices (CGMP), thereby leveraging quality as a competitive advantage.
All pharmaceutical manufacturers selling products in the United States are subject to extensive regulation by the United States federal government, principally by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA), and, to a lesser extent, by state and local governments. The Federal Food, Drug, and Cosmetic Act (FCDA), the Controlled Substances Act (CSA) and other federal and state statutes and regulations govern or influence the development, manufacture, testing, safety, efficacy, labeling, approval, storage, distribution, recordkeeping, advertising, promotion, sale, import and export of the company's products.
In the United States, the company's operations are subject to regulation by various federal, state and local authorities in addition to the FDA, including CMS, other divisions of the HHS, (e.g., the Office of Inspector General (OIG), Office for Civil Rights (OCR) and the Health Resources and Service Administration (HRSA)), the DOJ, and individual U.S. Attorney offices within the DOJ, and state and local governments.
The company's API facilities are required to comply with applicable cGMP requirements under U.S., European, Japanese and other applicable quality standards. Its API plants are regularly inspected by the FDA, European agencies and other authorities, as applicable.
History
Teva Pharmaceutical Industries Limited was founded in 1901. The company was incorporated in Israel in 1944.
