Seeking Alpha

Actavis files ANDA for diabetes drug

  • Actavis (ACT +0.3%) files an ANDA for a generic version of AstraZeneca (AZN -0.3%) and Bristol-Myers Squibb's (BMY +0.2%) Onglyza (saxagliptin hydrochloride), a treatment for glycemic control in adults with type 2 diabetes.
  • AZN filed suit against ACT on May 23, 2014 to prevent it from commercializing its generic version prior to the expiration of the '400 patent. The court instituted a stay of final FDA approval of the ANDA until January 31, 2017 or final resolution of the suit, whichever occurs sooner. ACT believes it is the first filer so it will be entitled to 180 days of generic market exclusivity upon regulatory clearance.
  • According to IMS Health Data, U.S. Onglyza sales were ~$532M for the 12-month period ending February 28, 2014.
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