Mylan granted US restraining order over sales of paroxetine

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Generics’ giant Mylan Laboratories was granted a US court order in September 2010 prohibiting Apotex, a Canadian pharma company, from selling paroxetine. The order also prohibits GlaxoSmithKline (GSK) from supplying Paxil CR (paroxetine extended-release tablets) to Apotex. Mylan has an exclusive agreement to sell a copy of GSK’s Paxil CR. If GSK were to authorise additional sales of generic paroxetine this would undercut sales and cause an “irretrievable loss of market share and customers” for generic Paxil CR, a Mylan spokesman said.

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Mylan had said it received patent licenses and the right to market generic versions of all three dosage strengths of the drug under a 2007 patent lawsuit settlement with GlaxoSmithKline. The agreement had provisions to allow other generic versions of Paxil CR to enter the market before the patent expired. GSK has not followed those terms, Mylan said.

GSK “did not breach any contractual duties owed to Mylan and intends to defend these allegations vigorously,” said a spokeswoman for the company. The court has scheduled further hearings for 18 October 2010.

References

Mylan Press Release. Mylan Granted Temporary Restraining Order Against GlaxoSmithKline and Apotex Prohibiting the Supply, Sale and/or Importing of a Generic Version of Paxil CR. 21 September 2010.

Mylan had said it received patent licenses and the right to market generic versions of all three dosage strengths of the drug under a 2007 patent lawsuit settlement with GlaxoSmithKline. The agreement had provisions to allow other generic versions of Paxil CR to enter the market before the patent expired. GSK has not followed those terms, Mylan said.

GSK “did not breach any contractual duties owed to Mylan and intends to defend these allegations vigorously,” said a spokeswoman for the company. The court has scheduled further hearings for 18 October 2010.

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