Pharmaceuticals
Company Overview of Teva Pharmaceuticals USA, Inc.
Company Overview
1090 Horsham Road
North Wales, PA 19454
United States
Founded in 1945
Key Executives for Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc. Key Developments
Attorney General Chris Koster announced the joint lodging of a consent decree with EPA in federal court to resolve environmental violations at Teva Pharmaceuticals USA. Teva manufactures antibiotics at its plant outside of Mexico, Missouri, in Audrain County. In December 2008, a fluorescent green-colored discharge from Mexico's wastewater treatment plant was observed in the Salt River. The discharge discolored the Salt River for more than 22 miles, to Mark Twain Reservoir. The discharge was traced by state and federal environmental officials to Teva. Inspections of Teva's waste management practices and operations revealed violations of state and federal environmental laws designed to protect the air and water, as well as hazardous waste management violations. Under the terms of the settlement, Teva will visually observe its water discharge at least once a day, assess past violations and recommend actions to prevent a reoccurrence, make sure all hazardous-waste containers are properly labeled and stored, and implement an enhanced leak detection program. Teva will undertake mitigation projects to reduce hazardous emissions and pay a $2.25 million civil penalty. One-half of that penalty will be paid by Teva to the Audrain County School Fund. Teva further agreed to pay the state of Missouri $26,000 for damages to natural resources, $65,684 in hazardous-waste fees and taxes, $1,752 in air-emission fees, and $59,357 for the state's investigative costs.
Pfizer Inc. announced that the United States Patent & Trademark Office has granted the company a reissue patent, covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex. The reissue patent will expire on December 2, 2015, which includes six months of pediatric exclusivity. The basic patent for celecoxib expires on May 30, 2014, which also includes six months of pediatric exclusivity. Pfizer also announced it has filed suit against Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals Inc., Watson Laboratories, Inc., Lupin Pharmaceuticals, USA, Inc., Apotex Corp. and Apotex, Inc. in the United States District Court for the Eastern District of Virginia for infringement of the reissue patent. Each of those generic companies previously filed an abbreviated new drug application with the United States Food and Drug Administration seeking approval to market a generic form of celecoxib in the United States beginning in May 2014, prior to the December 2, 2015 expiration of the reissue patent.
Gilead Sciences Inc. announced that Gilead and Teva Pharmaceuticals have reached an agreement in principle to settle the ongoing patent litigation concerning the patents protecting Viread (tenofovir disoproxil fumarate), a treatment for HIV infection and chronic hepatitis B. Under the terms of the settlement, Teva will be allowed to launch a generic version of Viread on December 15, 2017. The trial in this litigation, which was scheduled to begin on February 20, 2013 in the District Court for the Southern District of New York, has been adjourned pending completion of activities necessary to finalize the settlement.
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