Company Overview of Par Pharmaceutical Companies Inc.
Par Pharmaceutical Companies, Inc. develops, licenses, manufactures, markets, and distributes generic drugs in the United States. It operates through two segments, Par Pharmaceutical and Par Specialty Pharmaceuticals. The Par Pharmaceutical segment markets generic products under Par Pharmaceutical brand name and sterile products under the Par Sterile brand. This segment also offers dosage forms and delivery systems, including oral solids and alternate dosage forms, such as oral solids, injectables, topicals, nasal sprays, ophthalmics, films, and transdermal patches. In addition, this segment markets pharmaceutical products, including Exforge, Lovaza, Precedex, Lamictal XR, Luvox CR, and Foca...
One Ram Ridge Road
Chestnut Ridge, NY 10977
Founded in 1978
Key Executives for Par Pharmaceutical Companies Inc.
Chief Executive Officer and Director
Chief Financial Officer, Executive Vice President, Treasurer and Director
Senior Vice President and General Counsel of Generics
Compensation as of Fiscal Year 2015.
Par Pharmaceutical Companies Inc. Key Developments
Supernus Announces Settlement with Par Pharmaceutical Companies and Par Pharmaceutical on Trokendi XR Patent Litigation
Oct 15 15
Supernus Pharmaceuticals, Inc. announced that it has entered into a settlement agreement with Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. involving the ongoing patent litigation regarding Par's filing of an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Supernus' Trokendi XR® (extended-release topiramate) capsules. The settlement permits Par to begin selling a generic version of Trokendi XR® on April 1, 2025, or earlier under certain circumstances. The agreement is subject to entry of a consent judgment by the U.S. District Court for the District of New Jersey. In the consent judgment, Par acknowledges that the Orange Book-listed patents for Trokendi XR® owned by Supernus, namely United States Patent Nos. 8,298,576, 8,298,580, 8,663,683, 8,877,248, 8,889,191, and 8,992,989, are valid and enforceable with respect to Par's ANDA product, and would be infringed by Par's ANDA product. The agreement will be submitted to the applicable governmental agencies. The patent litigation continues against Actavis and Zydus, the other two ANDA filers. Patent protection for Trokendi XR® expires no earlier than 2027 and Supernus intends to continue its vigorous enforcement of its patent rights.
Par Pharmaceutical Begins Shipment of Generic Androgel® 1%
Sep 2 15
Par Pharmaceutical announced that it has begun shipping testosterone gel 1%. The U.S. Food and Drug Administration previously approved Par's Abbreviated New Drug Application for the product. Testosterone gel 1% is the generic version of AbbVie's AndroGel® 1% and is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Par previously entered into a settlement and license agreement and consent decree that permit Par to launch the product at this time, which is five years earlier than the expiration of the relevant patent. Testosterone gel 1% is available in 2.5 g and 5 g aluminum foil packets containing 25 mg or 50 mg testosterone, respectively. According to IMS Health data, annual U.S. sales of testosterone gel 1% packets are approximately $206 million. Testosterone gel 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testosterone gel 1% is contraindicated in women who are or may become pregnant, or who are breast feeding. Testosterone gel 1% may cause fetal harm when administered to a pregnant woman. Testosterone gel 1% may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with testosterone gel 1%. If a pregnant woman is exposed to testosterone gel 1%, she should be apprised of the potential hazard to the fetus. A black box warning for secondary exposure to testosterone is associated with this product.
Par Pharmaceutical Begins Shipment of Generic Sodium Edecrin
Aug 4 15
Par Pharmaceutical announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ethacrynate sodium for injection USP, equivalent to ethacrynic acid 50 mg. Ethacrynate sodium is the generic version of Aton Pharma's Sodium Edecrin® and is used in the treatment of edema. Par's ethacrynate sodium for injection USP, 50 mg is the first and only generic available. Par has begun shipping ethacrynate sodium for injection USP, which is packaged in cartons of one 50 mg single-dose vial. According to IMS Health data, annual U.S. sales of Sodium EdecrinÂ® are approximately $40 million.
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