Sign in Subscribe
Pharmaceutical industry

Glenmark Pharmaceuticals Settles Patent Dispute, Gains Approval for Generic Colosevelam Hydrochloride Products

Strategic Insights

— 1 min read

Glenmark Pharmaceuticals, through its subsidiaries Glenmark Generics and Glenmark Generics Inc, USA, has resolved a patent infringement lawsuit with Daiichi Sankyo Inc and Genzyme Corporation over the Abbreviated New Drug Application (ANDA) for Colosevelam hydrochloride filed with the US Food and Drug Administration (USFDA). As part of the settlement, Glenmark has obtained a license allowing it to launch its generic Colosevelam hydrochloride products, which could enter the market as early as April 2, 2015. The lawsuit was filed in November 2010 in the US District Court for the District of Delaware, seeking to prevent Glenmark from commercializing its ANDA before the expiration of Orange Book patents.

Key Takeaways:

  • Glenmark Pharmaceuticals has settled a patent infringement lawsuit with Daiichi Sankyo Inc and Genzyme Corporation over its Abbreviated New Drug Application (ANDA) for Colosevelam hydrochloride.
  • The settlement allows Glenmark to launch its generic Colosevelam hydrochloride products, pending the approval of the US Food and Drug Administration (USFDA).
  • Daiichi Sankyo markets Colosevelam hydrochloride as Welchol for the treatment of primary hyperlipidemia and type 2 diabetes mellitus.
  • The total sales of Colosevelam hydrochloride were approximately $51 million for the oral suspension and $327 million for the tablet in the 12 months period ending December 2010, according to IMS Health.
  • Glenmark can launch its generic products as early as April 2, 2015, or under certain circumstances.
  • The lawsuit was filed in November 2010 in the US District Court for the District of Delaware.

Statistics:

  • Total 12-month sales of Colosevelam hydrochloride oral suspension approximately $51 million (IMS Health, 2010)
  • Total 12-month sales of Colosevelam hydrochloride tablet approximately $327 million (IMS Health, 2010)
  • Deadline for Glenmark to launch its generic products April 2, 2015 (pending USFDA approval)

Sources:

  • Accord Fintech Pvt. Ltd. (2011)
  • Daiichi Sankyo Inc
  • Genzyme Corporation
  • US Food and Drug Administration (USFDA)
  • IMS Health
  • US District Court for the District of Delaware (2010)

Read more