Following the approval from the 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), Natco Pharma will launch the drug on November 1, 2019 or earlier in the US market.
Following the announcement, Natco shares were trading at Rs 626.30 apiece on BSE, up 4.86 per cent over the 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 firs-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 the US 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 $133 million for 12 months ended November, 2016, according to IMS Health, Natco said.