Mylan Inc. and Pfizer Inc. informed that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Teva that will resolve pending patent litigation related to its abbreviated new drug application (ANDA) for a generic epinephrine auto-injector.
According to the terms of the settlement, Teva may launch a generic epinephrine auto-injector covered by its ANDA on June 22, 2015 or earlier under certain circumstances, subject to receipt of approval from the US Food and Drug Administration (FDA). Teva currently does not have tentative approval from the FDA for its epinephrine auto-injector product.
Meridian manufactures EpiPen Auto-Injector and Mylan Specialty markets and distributes the product in the United States.
Additional terms of the agreement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.
Pfizer strives to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. The diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products.