Glenmark Pharmaceuticals stated in a regulatory filing that it received final FDA approval for its generic version of Forest Laboratories’ hypertension treatment Bystolic (nebivolol).
“With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was one of the first ANDA [abbreviated new drug application] applicants to submit a substantially complete filing for nebivolol tablets” covering various dosages, the Indian drugmaker noted.
The company also said that under the terms of a 2013 settlement agreement with Forest, it will be able to market and distribute its product under a licence from Forest three months, or possibly earlier in certain circumstances, before the expiration of a specific US patent, including any extension or paediatric exclusivity. In addition to Glenmark, Forest has similar patent litigation settlements for Bystolic with Alkem, Amerigen, Hetero, Indchemie and Torrent Pharmaceuticals.
Citing IMS Health sales data for the 12 months to March 2017, Glenmark said Bystolic had annual sales of approximately $1 billion.