Innovator Pozen (announced in a press release here) and generic player Teva settled patent litigation w.r.t generic version of the migraine treatment Sumatriptan and Naproxen (Treximet) 85 mg+500 mg Tablets.
Innovator Pozen has strong patent portfolio on this formulation. The listed patent has claims on method of use, formulation and pharmacokinetic properties of the combination
Both parties were in litigation at U.S. District Court for the Eastern District of Texas w.r.t following patents:
US6,060,499 (Expiry: Aug 14, 2017) : Which covers a method for treating a migraine patient by administering a 5-HT agonist, the improvement which comprises: concomitantly administering to said patient a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID) in an amount that, together with said 5-HT agonist, is effective to reduce migraine relapse or produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence
US6,586,458 (Expiry: Aug 14, 2017): Which covers a method of treating a patient for migraine headache, comprising: (a) administering a 5-HT agonist to said patient, wherein said 5-HT agonist is a triptan; and (b) administering a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID) to said patient, wherein said LA-NSAID has a pharmacokinetic half-life of at least 4 hours and a duration of action of at least 6 hours; wherein: (i) said 5-HT agonist and said LA-NSAID are concomitantly administered in unit dosage form; and (ii) the respective amounts of said 5-HT agonist and said LA-NSAID administered to said patient are sufficient to produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID or the administration of said LA-NSAID in the absence of said 5-HT agonist.
US7,332,183 (Expiry: Aug 14, 2017): Which covers a multilayer pharmaceutical tablet comprising naproxen and a triptan and, wherein: a) substantially all of said triptan is in a first layer of said tablet and substantially all of said naproxen is in a second, separate layer; and b) said first layer and said second layer are in a side by side arrangement such that the dissolution of said naproxen occurs independently of said triptan.
Under the terms of the Settlement Agreement, litigation against Teva will be dismissed without prejudice from the consolidated litigation currently pending in the United States District Court for the Eastern District of Texas against Teva, Par Pharmaceutical, Inc., Alphapharm Pty Ltd., and Dr. Reddy's Laboratories, Inc., but will agree to be bound by the outcome of such litigation or any resulting settlements with third parties.
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