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Business News/ News / World/  FDA ruling blocking celebrex generics reversed in Mylan win
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FDA ruling blocking celebrex generics reversed in Mylan win

The law governing versions of Celebrex is 'unambiguous' in favor of generics, a US appeals court said

Mylan Pharmaceuticals filed a suit in April, challenging FDA rulings on eligibility to market generics. Photo: BloombergPremium
Mylan Pharmaceuticals filed a suit in April, challenging FDA rulings on eligibility to market generics. Photo: Bloomberg

Wilmington: A US appeals court reversed a Food and Drug Administration (FDA) ruling that effectively blocked until June Mylan Pharmaceuticals Inc., Watson Laboratories Inc. and Lupin Pharmaceuticals Inc. from selling generic versions of the arthritis drug Celebrex, paving the way for low-cost alternatives.

The law governing versions of Celebrex, which generates $3 billion in sales annually for Pfizer Inc., is “unambiguous" in favor of generics, the US court of appeals in Richmond, Virginia, said in a ruling on Wednesday.

The generic drugmakers “sought to prevent the FDA from granting any other company a 180-day exclusivity period" to sell generics. The district court sided with the FDA. Today in the reversal, a three-judge panel said that under one patent, the exclusivity period expired on 9 November 2008, according to court papers. Celebrex was introduced in 1999.

Mylan filed the original suit in April, challenging FDA rulings on eligibility to market generics. Teva Pharmaceutical Industries Ltd, the world’s largest generic drugmaker, settled litigation with Pfizer in April. Reversal of the FDA decision bars Teva from selling the drug until June, according to Bloomberg Intelligence, because it’s no longer included in the first group of filers.

Joan Campion, a spokeswoman for New York-based Pfizer, and Nina Devlin, a spokeswoman for Canonsburg, Pennsylvania-based Mylan, didn’t immediately respond to voice-mail messages seeking comment on the ruling. Charlie Mayr, a spokesman for Parsippany, New Jersey-based Actavis Plc, which owns Watson Laboratories, wasn’t immediately available to comment.

Generic supply

“The decision would not have any bearing on Lupin’s supply of the authorized generic," Shamsher Gorawara, a Lupin spokesman, said in an e-mailed statement.

Under the Food, Drug, and Cosmetic Act, Congress sought to make low-cost generic medicines more available by creating an approval process that includes a 180-day exclusive right for the first company bringing a generic drug to market.

Mylan and Watson have also settled claims with Pfizer over Celebrex, the appeals court said.

The case is Mylan v. FDA, 14-1522, US court of appeals for the Fourth Circuit (Richmond). Bloomberg

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Published: 17 Dec 2014, 09:58 AM IST
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