HYDERABAD, Jan 6: Natco Pharma Ltd today said following the approval from US Food and Drug Administration for its generic version of Bendamustine Hydrochloride powder for injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial), it will launch the drug on November 1, 2019 or earlier in USA market.
Following the announcement, Natco shares are trading at Rs 626.30 apiece on BSE, up 4.86 per cent over previous close.
According to a statement issued by the city-based drug-maker, the drug will be launched along with its marketing partner Breckenridge Pharmaceutical Inc and will have 180-days exclusivity.
“Pursuant to the settlement of the Paragraph IV litigation, NATCO plans to launch this drug on November 1, 2019, or earlier under certain circumstances, through its marketing partner Breckenridge Pharmaceutical, Inc., in the USA market.
Natco and Breckenridge filed their ANDA with a Paragraph IV certification on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers,” Natco said.
Cephalon (acquired by Teva in 2011) sells Bendamustine Hydrochloride powder for injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial) under Brand name Treanda in USA market. Treanda is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma.
The drug had US sales of approximately USD 133 million for 12 months ending November, 2016, according to IMS Health, Natco said. (PTI)