No FDA nod, Caraco may miss exclusivity for diabetes drug

Although the US Fed has given the country a favorable verdict, clarity on the diabetes drug remains

Sun Pharmaceuticals, the largest Indian drug manufacturer, is unlikely to tap the US market for popular diabetes drug Prandin (repaglinide) with a marketing exclusivity.

 

Though the US federal court has given Caraco Pharmaceutical Laboratories, Ltd., the wholly-owned subsidiary of Sun Pharma, a favourable verdict related to the patent infringement on Prandin (repaglinide) - the diabetes drug patented by Novo Nordisk, Caraco is yet to receive the final approval from the US FDA. If Sun Pharma will not be able to launch the drug shortly, the company is likely to loose the chance for 180-day exclusivity, opine experts. Caraco has first-to-file (FTF) status on Prandin following its paragraph IV abbreviated new drug application (ANDA) submission.

 

The drug market for Prandin is $230 million in the US. Experts believe that Sun can get about 40 per cent of market share during 180-day exclusivity period. Caraco had applied for site transfer to make the drug as Caraco was under FDA scanner for lack of proper manufacturing norms.

 

The FDA had issued a warning letter in 2008 and seized drugs manufactured at the Detroit facility in 2009 over quality violations. In August 2012, Caraco had received clearance from US FDA to resume operations at its manufacturing facility and packaging sites at Detroit and Wixom, in Michigan.

 

Hitesh Mahida, pharma analyst at Fortune Equity Brokers said, "Caraco should receive the final marketing nod within 75 days after the favourable court verdict. If they receive the final nod, they will get 180-day exclusivity and can tap about 35-40 per cent market share."

 

Last week, the US Court of Appeals for the Federal Circuit has found the patent on Prandin (repaglinide), to be invalid. Novo Nordisk holds a patent for the combination of Prandin and metformin for the treatment of type II diabetes. In the US, the patent for Prandin has expired while patent for the combination PrandiMet will expire in 2018. Paving way for generic drug entry, the US Court found the patent to be invalid.

 

Novo Nordisk had filed a patent infringement lawsuit against Caraco in the US District Court for the Eastern District of Michigan, in June 2005, following Caraco's paragraph IV ANDA filing for the generic version of Prandin. In January 2011, when US district court found Novo's patent was invalid, Novo Nordisk appealed this decision at the US Court of Appeals for the Federal Circuit.

 

A Sun Pharma spokesperson said, "Caraco does not have the final approval for the product as yet. Caraco's FDA clearance came last year and Caraco had previously said in a filing that they had site transferred the product to a third party site in the US."

 

Apart from Caraco Pharma, Novo Nordisk has filed patent infringement lawsuits against three other companies, including Indian major- Aurobindo Pharma Ltd.

 

As of Mar 2013, ANDAs for 138 products are awaited approval (including 17 tentative approvals) for the Sun Pharma group. While there are 93 ANDA pending approval for Sun Pharma (with 9 tentative approvals), Caraco has 24 Products pending (with 5 tentative approvals) and Taro has 21 Products pending (with 3 tentative approvals) to get final US FDA nod.