Glenmark Pharmaceuticals Ltd confirmed that Abbott has filed suit on December 07, 2007 in the US district court of New Jersey, seeking to prevent Glenmark from proceeding with the commercialization of its trandolapril; verapamil hydrochloride products which is currently marketed by Abbott as Tarka.
TARKA® (trandolapril/verapamil hydrochloride ER) combines a slow release formulation of a calcium channel blocker verapamil hydrochloride {benzeneacetonitrile, (alpha)[3-[ [2-(3,4- dimethoxyphenyl) ethyl] methylamino] propyl]-3, 4-dimethoxy-(alpha)-(1-methylethyl) hydrochloride}, and an immediate release formulation of an ACE inhibitor, trandolapril {(2S,3aR,7aS)-1-[(S)-N-[ (S)-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester}. The tablet strengths are trandolapril 2 mg/verapamil hydrochloride ER 180 mg, trandolapril 1 mg/verapamil hydrochloride ER 240 mg, trandolapril 2 mg/verapamil hydrochloride ER 240 mg, and trandolapril 4 mg/verapamil hydrochloride ER 240 mg. The tablets also contain the following ingredients: corn starch, dioctyl sodium sulfosuccinate, ethanol, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate.
The product had sales of approximately $100 million in the US market.
Glenmark has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking regulatory approval to market a generic version of trandolapril; verapamil hydrochloride which included a paragraph IV certification with respect to patent listed by "Abbott" in the FDA "Orange Book." Glenmark believes it is the only applicant to have filed an ANDA for this product with a paragraph IV certification. In the event that Glenmark successfully challenges Abbott's patent, Glenmark will be entitled to a 180 day exclusivity period.
With this filing, Glenmark has four first to file positions for various products e.g. ezetimibe, desloratadine, atomoxetine hydrochloride. On successful patent challenges company will have shared exclusivity for the desloratadine and atomoxetine whereas in the case of ezetimibe Glenmark will be the sole Company who will be entitled for the 180 days exclusivity.Additionally, Glenmark has an on-going shared exclusivity on trileptal (an $800 million product). Having completed two months on the market, Glenmark has garnered a substantial market share to lead the generic pack.The approval of trileptal offered Glenmark its first 180 day exclusivity in the US market and with this the company now has a portfolio of 21 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process/launch.
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