Aurobindo Pharma, USA, has been dragged to the Court for patent infringement by Astrazeneca. The suit filed is against the ANDA (Abbreviated New Drug Application) filed by Aurobindo Pharma with the USFDA with regard to seeking the market approval for Saxagliptin hydrochloride tablets before the expiry of its US patent. Aurobindo Pharma plans to market the generic versions of Saxagliptin hydrochloride tablets of 2.5 mg and 5 mg strengths.
Astrazeneca is the sole marketer of Saxagliptin hydrochloride tablets having got marketing approval from the FDA through an NDA (New Drug Application) and markets the drug in the US under the brand name Onglyza. Onglyza (saxagliptin) is an oral dipeptidyl peptidase 4 (DPP-4) inhibitor used for the treatment of Type-2 Diabetes Mellitus. These drugs act by promoting insulin secretion by the pancreas and control the liver from excess sugar production. It is a popular drug that effectively controls blood sugar without weight gain like other anti-diabetics.