Drug firm Natco Pharma today said American pharma company Celgene Corporation has filed a lawsuit against it in the US seeking to prevent it from marketing generic Lenalidomide capsules used to treat cancer.
Natco had filed an ANDA with the US Food and Drug Administration (USFDA) seeking approval to market generic Lenalidomide capsules (branded as Revlimid), the patent for which is held by the American firm, in strengths of 5 mg, 10 mg, 15 mg and 25 mg.
Celgene had filed the lawsuit on October 8 to prevent Natco from commercialising the drug before the expiration of the patent, Natco pharma said in a filing to the Bombay Stock Exchange.
It, however, did not specify when the patent would expire.
The lawsuit has resulted in stay of final approval by the US health regulator on Natco's Abbreviated New Drug Application for 30 months or until final resolution of the matter by the court, whichever is earlier, it added.
Natco said that it believes it may be a first applicant to file an ANDA for generic version of Revlimid and may be entitled to 180 days of generic market exclusivity.
Shares of Natco Pharma were trading at Rs 281 on the BSE in the afternoon trade, down 0.27 per cent from its previous close.