According to a Bloomberg article, Mylan Inc. has been granted a temporary order prohibiting Apotex Inc. from selling a generic form of Paxil CR. Presided over by U.S. District Judge Joe Pisano and given by a Federal Court in Trenton, New Jersey, the order blocks Apotex from using, offering to sell, selling, shipping and launching generic Paxil CR.
Mylan’s lawsuit in the case of Mylan Inc. v. Smithkline Beecham Corp. claims that Glaxo was allowing Apotex to sell the Paxil CR under the name paroxetine hydrochloride. This violated an exclusive licensing agreement that Mylan had with GlaxoSmithKline to sell copy of Paxil CR. Pisano set the hearing in the case for October 18, 2010, but not before granting the temporary order against Apotex.
Mylan currently is the largest U.S.-based generic drug company. Its lawsuit claims that Glaxo vowed that Mylan would be the only company selling copies of the drug Paxil CR in its controlled-release form as a result of a settlement agreement that was reached in 2007. This agreement was the result of a lawsuit that was filed against Mylan that wanted to block the sales of generic Paxil CR. The agreement also had provisos that would let other versions of the drug out on the market before the patent expires — a term of the agreement that Glaxo violated, Mylan stated. Mylan also claims that they were the first generic drug maker that went after regulatory approval for the 12.5 mg and 25 mg forms of Paxil CR since the regular forms of the drug already have many copies out on the market.
Mylan says the authorized generic version of Paxil CR would undercut sales and cause an “irretrievable loss in market shares and customers.”
Sarah Alspach, a spokesperson for Glaxo, has stated that “Glaxo did not breach any contractual duties owed to Mylan and intends to defend these allegations vehemently.”