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.
In the first week of December this year, Aurobindo informed Astrazeneca through a notice letter that they have submitted an ANDA application to the FDA seeking market approval to engage in the commercial manufacture, use and sale of Saxagliptin hydrochloride tablets before the expiry of its patent under Section 505(j) of the Federal Food, Drug, and Cosmetic Act.
Onglyza was developed initially by Bristol-Myers Squibb and Astrazeneca partnered in its development since 2007. They had jointly submitted an NDA to the USFDA in 2008 and got approval for the treatment of type-2 Diabetes in 2009. Even Saxagliptin was granted a marketing authorization from the European Medicines agency and was approved in more than 66 countries including India. Later the drug outright was bought from Bristol-Myers Squibb by Astrazeneca.
In February, 2014, the FDA had put Saxagliptin for review and issued a safety announcement with respect to the heart failure risks. The manufacturers were asked to submit the clinical trial data within a month. While submitting the NDA, the data submitted along with for the support was ruling out any cardiovascular risk.
According to a court order, the submission of ANDA by Aurobindo Pharma prior to the patent expiry constitutes a technical act of infringement and from the primary information available, one or two claims of the unexpired patent would be infringed by the product described in the ANDA. Astrazeneca will suffer huge irreparable losses if Aurobindo is not enjoined from the approval.