Mylan Inc., the generic-drug maker with an exclusive agreement to sell a copy of GlaxoSmithKline Plc’s Paxil CR, said it won a temporary court order blocking Apotex Inc. from also selling the antidepressant medicine.
Mylan, which says it has a licensing agreement, claimed in a lawsuit yesterday that Glaxo is letting Apotex sell Paxil CR under the chemical name paroxetine hydrochloride. The order today by a federal court in Trenton, New Jersey, blocks Apotex from “using, offering to sell, selling or shipping or otherwise launching” generic Paxil CR, Mylan said in a statement.
U.S. District Judge Joel Pisano set a hearing on the case for Oct. 18. Mylan, the largest U.S.-based generic-drug company, said Glaxo pledged that it would be the only company selling copies of Paxil in controlled-release form as part of a 2007 settlement of a lawsuit over a Glaxo patent expiring in 2016.
The so-called authorized generic would undercut sales and cause an “irretrievable loss of market share and customers” for generic Paxil CR, Canonsburg, Pennsylvania-based Mylan said in its complaint. Mylan asked the court to rule that Glaxo breached the agreement and Apotex can’t sell the generic.
Glaxo “did not breach any contractual duties owed to Mylan and intends to defend these allegations vigorously,” Sarah Alspach, a spokeswoman for the company, said in an e-mail.
Toronto-based Apotex, Canada’s biggest drugmaker, and London-based Glaxo planned to sell an authorized generic version of Paxil CR in 12.5-, 25- and 37.5-milligram forms, according to the complaint. Sales were to begin yesterday.
Paxil CR generated 136 million pounds ($212 million) for Glaxo in the U.S. in 2007, the year before Mylan entered the market.
Since May 2008, Mylan’s generic version generated “hundreds of millions of dollars in sales” in the U.S., according to the complaint. Mylan reported about $5 billion in sales last year.
The 2007 agreement followed a lawsuit Glaxo filed against Mylan that sought to block sales of generic Paxil CR. The agreement had provisions to allow other generic versions of Paxil CR to enter the market before the patent expired. Glaxo hasn’t followed those terms, Mylan said.
Mylan said then it was the first generic-drug maker to seek regulatory approval for the 12.5-milligram and 25-milligram forms of Paxil CR. The regular form of Paxil has multiple copies on the market.
A spokesman for Apotex, Elie Betito, didn’t return a call and e-mail seeking comment.
The case is Mylan Inc. v. SmithKline Beecham Corp., 10-cv- 4809, U.S. District Court for the District of New Jersey (Trenton).