Innovator Pozen and GlaxoSmithKline (GSK) has filed a lawsuit after they received a Para IV letter from Terva Pharma on April, 2009 w.r.t antimigraine medication Treximet (Sumatriptan 85 mg+Naproxen sodium 500 mg). Teva's letter advised POZEN and GSK that it intended to market a generic version of Treximet tablets before the expiration of following Orange Book listed patents:
US5037845: (Expiry: Aug 6, 2008): Expired patent, which covered sumatriptan as product
US6060499 (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 of said LA-NSAID.
US6586458 (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.
US7332183 (Expiry: Oct 2, 2025): 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
Innovator has sued generic player Teva for the infringement of ‘0499 and ‘458 patents in US district court of Eastern Texas.
Also, innovator has earlier sued generic players like Par, Mylan and Alphapharm in Novemebr, 2008 for filing ANDA with Para IV certification in US district court of Eastern Texas.
Earlier, innovator got approval on this combination on Apr 15, 2008. The New combination exclusivity on this product will expire on Apr 15, 2011.
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