Teva Pharmaceutical Industries Stock

Teva Pharmaceutical Industries Limited (Teva) operates as a global pharmaceutical company. The company engages in the development, manufacturing, marketing, and distribution of generics, specialty medicines, and biopharmaceuticals in the United States and Europe.

Segments

The company operates through three segments: North America, Europe, and International Markets. Each business segment manages its entire product portfolio in its region, including generics, specialty, and over-the-counter (OTC) products. 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.

North America

This segment includes the United States and Canada.

The company is one of the leading generic pharmaceutical companies in the United States. It markets over 550 generic prescription products in more than 1,600 dosage strengths, packaging sizes and forms, including oral solid dosage forms, injectable products, inhaled products, transdermal patches, liquids, 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 wholesale and retail selling efforts are supported by participation in key pharmaceutical conferences, as well as focused advertising in professional journals and on leading pharmacy websites. The company continues to strengthen consumer awareness of the benefits of generic medicines through partnerships and digital marketing programs.

The company’s specialty portfolio in North America focuses on three main areas, such as central nervous system (CNS), respiratory, and oncology.

The company’s CNS portfolio includes AJOVY for the preventive treatment of migraine in adults, AUSTEDO for the treatment of neurodegenerative and movement disorders – chorea associated with Huntington’s disease and tardive dyskinesia and COPAXONE, which is still among the leading products for the treatment of multiple sclerosis (MS) in North America. In August 2021, the U.S. Food and Drug Administration (FDA) accepted the new drug application (NDA) for risperidone LAI for the treatment of schizophrenia, based on phase 3 data from two pivotal studies.

The company is committed to maintaining a leading presence in the respiratory market by delivering a range of medicines for the treatment of asthma and chronic obstructive pulmonary disease (COPD), including ProAir, QVAR, and the company’s newly launched digital inhaler portfolio.

The company maintains a meaningful presence in oncology medicines, including both specialty and generic medicines (including biosimilars). In 2019, the company launched Truxima, its first oncology biosimilar product in the United States. BENDEKA is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride that the company licensed from Eagle Pharmaceuticals, Inc. (Eagle).

Anda, Inc. (Anda), the company’s distribution business in the United States, distributes generic, specialty and OTC pharmaceutical products from 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 secondary distribution market by maintaining high inventory levels for a broad offering of products, competitive pricing and offering next day delivery throughout the United States.

Europe

This 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. The company is among the top three generic pharmaceutical companies in a number of European markets, including some of the largest markets in the European Union.

The company is one of a few generic pharmaceutical companies with a pan-European footprint, while most of its competitors focus on a select few 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 in Germany and FLEGAMINA in Poland.

The company’s specialty portfolio in Europe focuses on three main areas, such as CNS (including migraine), respiratory and oncology. Its leading product, COPAXONE, continues to be among the leading products for the treatment of MS, though new treatments are being introduced to various markets in Europe. AJOVY was granted EU marketing authorization in 2019. As of December 31, 2021, the company launched AJOVY in most European countries and it is moving forward with plans to launch in other European countries.

International Markets

This segment includes all countries in which the company operates other than those in its North America and Europe segments. The International Markets segment includes more than 35 countries, covering a substantial portion of the global pharmaceutical market.

The company’s key international markets are Japan, Russia, and Israel. In Japan, the company operates a majority of its business through a business venture with Takeda Pharmaceutical Companies Limited (Takeda), in which the company owns a 51% stake and Takeda owns the remaining 49%. In February 2021, the company completed the sale of the majority of the generic and operational assets of its business venture in Japan.

The countries in the company’s International Markets segment include highly regulated, pure generic markets, such as 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 and specialty medicines product offerings and across various channels (e.g., retail and institutional).

The company’s specialty portfolio in its International Markets segment focuses on three main areas, such as CNS, respiratory and oncology.

Product Portfolio and Business Offering

The company’s product and service portfolio includes generic medicines, biopharmaceuticals, specialty medicines, OTC products, a distribution business, API and contract manufacturing. Each region manages the entire range of products and services offered in its region and its global marketing and portfolio function optimizes the company’s pipeline and product lifecycle across therapeutic areas. In most markets in which it operates, the company uses an integrated and comprehensive marketing model, offering a broad portfolio of products, including specialty, generic and OTC products.

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. Generics 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. The company 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. The company 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.

In November 2019 and February 2020, the company launched Truxima (rituximab-abbs), a biosimilar to Rituxan (rituximab), in the United States and in Canada, respectively. It is the company’s first oncology biosimilar product in the United States and is the first rituximab biosimilar to be approved in the United States.

In January 2020 and March 2020, the company launched Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin (trastuzumab), in Canada and the United States, respectively.

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 phase 3 clinical trials for biosimilars to Prolia (denosumab), Stelara (ustekinumab) and Xolair (omalizumab); a biosimilar to Lucentis (ranibizumab) that is under European regulatory review; and a biosimilar to Humira (adalimumab) that is under the U.S. regulatory review.

Specialty Medicines

The company’s specialty medicines business, which focuses on delivering innovative solutions to patients and providers via medicines, devices and services in key regions and markets around the world, includes its core therapeutic areas of CNS (with a strong emphasis on MS, neurodegenerative disorders, neuropsychiatry, movement disorders and migraine) and respiratory medicines (with a focus on asthma and COPD). The company also has specialty products in 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. The company 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 specialty business. In Europe and International Markets, the company leverages existing synergies between its specialty business and its generics and OTC businesses. The company’s specialty presence in International Markets is mainly built on its CNS, respiratory and oncology medicines.

Below is a description of the company’s key specialty products:

CNS (including Movement Disorders and Migraine)

The company’s CNS portfolio includes AJOVY for the preventive treatment of migraine, AUSTEDO for the treatment of tardive dyskinesia and chorea associated with Huntington’s disease, and COPAXONE for the treatment of relapsing forms of MS.

AJOVY

AJOVY (fremanezumab-vfrm) injection is a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and it is indicated for the preventive treatment of migraine in adults. AJOVY was launched in the U.S. in 2018. AJOVY was approved in Canada in April 2020.

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 the company’s International Markets segment. AJOVY was launched in Japan in August 2021. By the end of 2021, the company launched AJOVY in most European countries and in certain International Markets countries. The company 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 U.S. in April 2020 and in Canada in April 2021. The company has also received approval from the EMA for AJOVY’s auto-injector submission in the European Union in October 2019. The company commenced launch in March 2020.

AJOVY is the only anti-CGRP subcutaneous product indicated for quarterly treatment.

AJOVY is protected by patents expiring in 2026 in Europe and in 2027 in the United States. Applications for patent term extensions have been submitted in various markets around the world, and certain extensions in Europe and other countries have already been granted 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 and 10 years from marketing approval in Europe.

The company has 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. Lilly then submitted inter partes review (IPR) petitions to the Patent Trial and Appeal Board (PTAB), challenging the validity of the nine patents asserted against it in the litigation. The litigation in the district court was stayed pending resolution of the IPR petitions. In February 2020, the PTAB issued decisions on the first six IPRs, finding the six composition of matter patents invalid as being obvious. In March 2020, the PTAB issued a decision upholding the three method of treatment patents. In August 2021, the Court of Appeals for the Federal Circuit affirmed all of the PTAB’s decisions. The litigation is proceeding as to the three method of treatment patents and a trial is expected in 2022. The company also filed another suit against Lilly on June 8, 2021, asserting two patents granted to Teva, related to the treatment of refractory migraine. Lilly responded to the complaint with a motion to dismiss, which Teva is opposing. 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 the company’s AJOVY patents. The settlement agreement with Lilly also resolved Lilly’s action to revoke the patent protecting AJOVY in the United Kingdom.

AUSTEDO

AUSTEDO (deutetrabenazine) is a deuterated form of a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, which is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain. The FDA granted deutetrabenazine New Chemical Entity exclusivity until April 2022 and Orphan Drug exclusivity for the treatment of chorea associated with Huntington’s disease until April 2024.

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.

AUSTEDO was launched in China for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in early 2021. In October 2021, the company received marketing approval for both indications in Brazil. The company continues with additional submissions in various other countries around the world.

AUSTEDO is protected in the United States by seven Orange Book patents expiring between 2031 and 2038 and in Europe by two patents expiring in 2029. 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. In July 2021, the company filed a complaint against Aurobindo, asserting six of the Orange Book patents, and a separate complaint against Lupin, asserting four of the Orange Book patents. The suits were filed in the U.S. District Court for the District of New Jersey. The seventh patent was issued in November 2021, and listed in the Orange Book in December 2021. In addition, Apotex has filed a petition for IPR by the PTAB of the patent covering the deutetrabenazine compound that expires in 2031. The company responded to that petition on December 15, 2021.

COPAXONE

COPAXONE (glatiramer acetate injection) continues to play a major role in the treatment of MS in the United States (according to IQVIA data as of late 2021). 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.

One European patent protecting COPAXONE 40 mg/mL was found invalid by the Board of Appeal of the European Patent Office in September 2020. Two additional patents expiring in 2030 were found invalid at the European Patent Office in December 2021. In certain countries, Teva remains in litigation against generic companies on an additional COPAXONE 40 mg/mL patent that expires in 2030.

In December 2018, Teva sued Pharmascience regarding its application to sell a generic version of COPAXONE in Canada. In December 2020, the Canadian Federal Court issued a decision finding the 2028 method of use patent invalid and the 2030 dosing regimen patent valid and infringed. In January 2022, the Canadian Federal Court of Appeals affirmed Teva’s victory against Pharmascience on the 2030 dosing regimen patent. A re-examination proceeding initiated by Pharmascience at the Canadian Patent office that had been stayed, may resume. The company previously settled its Canadian litigation with Sandoz, regarding their application for a generic version of COPAXONE in Canada. Additionally, a case against Mylan Pharmaceuticals (Mylan) with respect to its Canadian application for a generic version of COPAXONE was stayed pending the outcome of the Pharmascience appeal, and may resume. Mylan’s 24-month stay for its product will likely be extended at least until 2023.

The market for MS treatments continues to develop, particularly with generic versions of COPAXONE. Oral treatments for MS, such as Tecfidera, Gilenya, and Aubagio, continue to present significant and increasing competition. COPAXONE also continues to face competition from existing injectable products, as well as from monoclonal antibodies, such as Ocrevus.

Oncology

The company’s specialty oncology portfolio includes BENDEKA / TREANDA, GRANIX, and TRISENOX in the United States; and LONQUEX, TEVAGRASTIM/RATIOGRASTIM and TRISENOX outside the United States.

BENDEKA and TREANDA

BENDEKA (bendamustine hydrochloride) injection and TREANDA (bendamustine hydrochloride) for 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 the company licensed from Eagle.

BENDEKA faces direct competition from Belrapzo (a ready-to-dilute bendamustine hydrochloride product from Eagle). 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.

In July 2018, Eagle prevailed in its suit against the FDA to obtain seven years of orphan drug exclusivity in the United States for BENDEKA. In March 2020, this decision was upheld in the appellate court. As things stand, drug applications referencing BENDEKA, TREANDA or any other bendamustine product will not be approved by the FDA until the orphan drug exclusivity expires 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 the company sells BENDEKA and increased the royalty rate. In consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses.

There are 16 patents listed in the U.S. Orange Book for BENDEKA with expiry dates between 2026 and 2031. In September 2019, a patent infringement action against four of six ANDA filers for generic versions of BENDEKA was tried in the U.S. District Court for the District of Delaware. In April 2020, the district court upheld the validity of all of the asserted patents and found that all four ANDA filers infringe at least one of the patents. Three of the four ANDA filers appealed the district court decision. Teva settled with one of the three ANDA filers, and on August 13, 2021, the Federal Circuit issued a Rule 36 affirmance of the district court decision with respect to the other two filers. On December 14, 2021, Apotex filed a Petition for a Writ of Certiorari with the U.S. Supreme Court. Litigation against the fifth ANDA filer was dismissed after the withdrawal of its patent challenge, and the case against a sixth ANDA filer was also settled. Recent suits against two filers of 505(b)(2) NDAs referencing BENDEKA are also in initial stages of litigation.

Additionally, in July 2018, Teva and Eagle filed suit against Hospira, Inc. (Hospira) related to its 505(b)(2) NDA referencing BENDEKA in the U.S. District Court for the District of Delaware. On December 16, 2019, the district court dismissed the case against Hospira on all but one of the asserted patents, which expires in 2031. The trial on the remaining asserted patent has been postponed and is scheduled to begin on April 25, 2022.

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.

Respiratory

The company’s respiratory portfolio includes its legacy products, ProAir and QVAR, as well as the company’s new digital inhalers with built-in sensors: ProAir Digihaler, AirDuo Digihaler and ArmonAir Digihaler. The company’s portfolio also includes BRALTUS, CINQAIR/CINQAERO, DuoResp Spiromax and AirDuo RespiClick/ ArmonAir RespiClick.

The company is committed to maintaining a leading presence in the respiratory market by delivering a range of medicines for the treatment of asthma and COPD. Its portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development and commercialization of innovative delivery systems and therapies that help address unmet needs.

The key areas of focus for the company’s respiratory R&D are the development of differentiated respiratory therapies for patients using innovative delivery systems to deliver chemical and biological therapies. The company’s device strategy is intended to result in ‘device consistency’, allowing physicians to choose the device that best matches a patient’s needs both in terms of ease of use and effectiveness of delivery of the prescribed molecule, and includes three main types of devices, such as Digihaler, which captures and shares objective inhaler use data; a breath-actuated inhaler (BAI) used in QVAR RediHaler; and RespiClick (the U.S.) or Spiromax (EU), a novel inhalation-driven multi-dose dry powder inhaler (MDPI).

The company’s legacy products include ProAir and QVAR:

ProAir HFA (albuterol sulfate) is an inhalation aerosol with dose counter and is indicated for patients four years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. ProAir HFA is among the leading quick relief inhalers in the United States. In January 2019, the company launched its own ProAir authorized generic in the United States following the launch of a generic version of Ventolin HFA, another albuterol inhaler. Other generic versions of ProAir were launched in 2020.

ProAir RespiClick (albuterol sulfate) inhalation powder is a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist inhaler for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients four years of age and older.

QVAR (beclomethasone dipropionate HFA) is indicated as a maintenance treatment for asthma as a prophylactic therapy in patients five years of age or older. QVAR is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR may reduce or eliminate the need for systemic corticosteroids. Three generic manufacturers have filed ANDAs for the metered-dose inhaler (MDI) presentation of QVAR. The company is asserting its patents against two of those ANDA filers in the U.S. District Court for the District of New Jersey. In November 2021, the district court held a hearing regarding the interpretation of certain claims terms, and the decision is pending. No trial date has been set for these pending lawsuits.

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.

The company’s Digihaler portfolio consists of ProAir Digihaler, ArmonAir Digihaler and AirDuo Digihaler that capture objective inhaler use data that may help health care professionals and patients make more informed treatment decisions that may improve health outcomes:

ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder was launched in the U.S. in July 2020. It is the first and only digital rescue inhaler with built-in sensors, which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD.

ArmonAir Digihaler (fluticasone propionate MDPI U.S.) was launched in the U.S. in September 2020. It is a formulation of long acting inhaled corticosteroid (ICS) using the company’s MDPI device, indicated for maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

AirDuo Digihaler (fluticasone propionate and salmeterol inhalation powder) was launched in the U.S. in September 2020. It is the first and only digital maintenance inhaler with built-in sensors, which connect to a companion mobile application and provides inhaler use information to people with asthma.

Additional products in the company’s respiratory portfolio include:

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.

AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) (and its authorized generic) is a combination of an inhaled corticosteroid and a long acting beta-agonist bronchodilator, approved in the United States for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an ICS or whose disease severity clearly warrants the use of an ICS/long-acting beta2-adrenergic agonist combination.

During 2021, development of the following projects was discontinued: fremanezumab for fibromyalgia and for an additional indication; and deutetrabenazine for an additional indication.

Other Activities

The company produces approximately 350 APIs for its own use and for sale to third parties in many therapeutic areas. The company utilizes a variety of production technologies, including chemical synthesis, semi-synthetic fermentation, enzymatic synthesis, high potency manufacturing, plant extract technology and peptide synthesis. Its advanced technology and expertise in the field of solid state particle technology enable the company 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 its North America, Europe and International Markets segments.

Research and Development (R&D)

The company’s R&D activities span the breadth of its business, including generic medicines (finished goods and API), biosimilars, specialty medicines and OTC medicines.

The company’s specialty R&D product pipeline focuses on biologic and select small molecule products. Specialty development activities include preclinical assessment (including toxicology, pharmacokinetics, pharmacodynamics and pharmacology studies), clinical development (including pharmacology and the design, execution and analysis of global safety and efficacy trials), as well as regulatory strategy to deliver registration of its pipeline products. The company develops novel specialty products in its core therapeutic and disease focus areas. The company has neuroscience projects in areas, such as migraine, movement disorders/neurodegeneration and neuropsychiatry. The company’s immunology projects focus on respiratory medicines and include both novel compounds and delivery systems designed to address unmet patient needs.

The company’s API R&D division focuses on the development of processes and physical compound characterization for the manufacturing of APIs, including intermediates, synthetic and fermentation products, for both its generic and proprietary drugs. The company’s facilities in various locations worldwide include two large development centers focusing on synthetic products, three centers with specific expertise specializing in fermentation and semi-synthetic products, a center for oligonucleotides and peptides, and centers for high-potency APIs.

The company’s net R&D expenses were $967 million for 2021.

Regulation

All pharmaceutical manufacturers selling products in the United States are subject to extensive regulation by the United States federal government, principally by the FDA and the Drug Enforcement Administration (DEA), and to a lesser extent, by state and local governments. The Federal Food, Drug, and Cosmetic Act; 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.

The company’s facilities are periodically inspected by the FDA, which has extensive enforcement powers over the activities of pharmaceutical manufacturers.

The company’s API facilities are required to comply with applicable cGMP requirements under the 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.