June 24, 2018 3:52 PM ET

Pharmaceuticals

Company Overview of Teva Pharmaceuticals USA, Inc.

Company Overview

Teva Pharmaceuticals USA, Inc. manufactures and markets generic drugs in the United States. It offers generic products for various therapeutic options, such as cardiovascular, anti-infective, central nervous system, anti-inflammatory, oncolytic, anti-diabetic, analgesic, dermatologic, respiratory, and women’s health. The company offers its products in various dosage forms, such as tablets, capsules, injectables, creams, ointments, inhalants, solutions, and suspensions. It serves patients through distributors. Teva Pharmaceuticals USA, Inc. was formerly known as Lemmon Pharmacal Company and changed its name to Teva Pharmaceuticals USA, Inc. in 1996. The company was founded in 1945 and is base...

1090 Horsham Road

North Wales, PA 19454

United States

Founded in 1945

Phone:

215-591-3000

Fax:

215-591-8600

Key Executives for Teva Pharmaceuticals USA, Inc.

Vice President of Government Affairs
Vice President of Government Affairs
Vice President of Government Affairs
Vice President of Government Affairs
Compensation as of Fiscal Year 2017.

Teva Pharmaceuticals USA, Inc. Key Developments

Amarin Corporation plc Enters into a Settlement Agreement with Teva Pharmaceuticals USA, Inc

Amarin Corporation plc entered into a settlement agreement with Teva Pharmaceuticals USA, Incthat resolves Amarin’s previously reported Vascepa® (icosapent ethyl) patent litigation as it relates to Teva’s abbreviated new drug application seeking U.S. Food and Drug Administration (FDA) approval of generic forms of Vascepa (icosapent ethyl) capsules. This patent litigation continues in the United States District Court for the District of Nevada with parties West-Ward Pharmaceuticals Corp. and Dr. Reddy’s Laboratories, Inc. and their affiliated entities. In the lawsuit, Amarin alleges that the generic forms of Vascepa adverse parties seek to market in the United States infringe upon multiple patents owned by Amarin. As part of the settlement agreement, Teva may first begin selling its generic version of Vascepa in the United States on August 9, 2029, or earlier under certain customary circumstances, including commercial launch by another generic manufacturer under certain circumstances, in which event Teva would pay Amarin royalties on its generic version of Vascepa. The agreement also provides that Amarin will pay Teva $2.0 million in recognition of the savings to Amarin in the avoidance of costs, expenditure of time and resources, disruption and burden associated with continued litigation with Teva. The agreement is subject to a required review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

Teva Pharmaceuticals Presents at ISM2018, Institute for Supply Management’s Annual Conference, May-08-2018 03:45 PM

Teva Pharmaceuticals Presents at ISM2018, Institute for Supply Management’s Annual Conference, May-08-2018 03:45 PM. Venue: Gaylord Opryland Resort & Convention Center, Nashville, Tennessee, United States. Speakers: James Akers, SVP, Global Procurement.

Egalet US, Inc. and Egalet Ltd. File Patent Infringement Lawsuit against Teva Pharmaceuticals USA, Inc

On April 4, 2018, Egalet US, Inc. and Egalet Ltd., subsidiaries of Egalet Corporation, filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals USA, Inc. The lawsuit was filed under the Hatch-Waxman Act for Teva’s infringement of one of Egalet’s patents for ARYMO ER listed in the approved drug products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book— U.S. Patents No. 9,044,402. The lawsuit was filed in response to a paragraph IV certification Egalet received from Teva on February 23, 2018, stating that Teva had submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration for a generic version of ARYMO ER (morphine sulfate) extended-release tablets. Teva, as an ANDA applicant, is required to make certain certifications to the FDA concerning any patents listed for the approved product in the Orange Book. A paragraph IV certification is a certification that the new product will not infringe an approved product’s listed patents, or that such patents are invalid. This patent for ARYMO ER was granted following review by the U.S. Patent and Trademark Office, is presumed to be valid under governing law, and can only be invalidated in federal court with clear and convincing evidence. Teva’s paragraph IV certification alleges that this U.S. patent is invalid and/or will not be infringed by Teva’s proposed product. Under the Hatch-Waxman Act, Egalet was permitted to file suit within 45 days from its receipt of the paragraph IV certification and thereby automatically stay or bar the FDA from approving Teva’s ANDA for 30 months or until a district court decision that is adverse to the asserted patents, whichever is earlier. Egalet believes the assertions in Teva’s paragraph IV certification do not have merit, and Egalet intends to vigorously enforce its intellectual property rights relating to ARYMO ER.

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