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Global drug major Takeda Pharmaceuticals has dragged two Indian drug firms — Granules India and Hetero Drugs — to court over charges of patent infringement of its drug to treat Gout and Familial Mediterranean Fever.
Granules India and Hetero Drugs, both headquartered in Hyderabad, have recently filed ANDAs (Abbreviated New Drug Application) with the US Food and Drug Administration seeking approval to sell the generic version of the drug Colcrys (Colchicine USP).
The drug is used for treating and preventing gout flares and Mediterranean fever. Takeda Pharmaceuticals, the Japanese giant, has filed a patent infringement case in the US District Court for the District of Delaware to prevent the two firms from selling the drug in the US market.
Colchicine has been around as a medication in the US, mostly used to treat gout. Originally extracted from plants, it is a toxic natural product and secondary metabolite. Takeda Pharma holds the NDA (New Drug Approval) for Colcrys to treat gout, which the USFDA granted approval in 2009 for commercial manufacture and sale exclusively for a defined period.
The estimated market for the drug is $450 million. Interestingly, Takeda already has a case pending against Mylan over the drug patent. Colcrys and Tekeda’s authorised generic of Colcrys are the only oral single active ingredient Colchicine products approved by the FDA for treatment of gout.
Granules India in its Para IV notice in July claimed that it is entitled to bring its product to the market prior to the expiration of Takeda's patents because “they are invalid, unenforceable and would not be infringed”.
The company has produced a 0.6 mg Colchicine dosage version and sought the FDA approval to sell its generic version to treat Mediterranean fever.
Incidentally, in May 2016, according to a Reuters report, Takeda Pharma suffered a setback when it lost a patent infringement case to Hikma Pharmaceuticals, UK. The Delaware Court backed Hikma’s rights to sell a drug Mitigare with the same active ingredient as Takeda’s Colcrys, because it was not indicated for uses covered by the patent in question.
Gout is a form of severe arthritis due to build up of uric acid in the body. Familial Mediterranean fever is a hereditary inflammatory disorder, which occurs usually in people from that region.
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