Updated on 4 October 2012
In early September 2012, Mylan representatives once again contacted the FDA seeking information on the 180-day exclusivity forfeiture decision for valsartan tablets. According to the company, FDA did not provide any substantial information about the approval status of the ANDAs.
On September 28, 2012, FDA granted tentative approval to Mylan's ANDA for Valsartan Tablets 40 mg, 80mg, 160 mg and 320 mg. However, it refused to grant final approval to Mylan's ANDA because the agency determined that another applicant (Ranbaxy) was entitled to 180-day generic exclusivity.
New Delhi-based Ranbaxy refused to comment on the matter.
Mylan said that the FDA determined that Ranbaxy's failure to obtain timely tentative approval was caused by a change in approval process of the application imposed after the date on which Ranbaxy's valsartan tablet ANDA was filed and, therefore, Ranbaxy has not actually forfeited its exclusivity to obtain timely tentative approval. Mylan, however, notes in the complaint that "there has been no change in the requirements for approval that directly caused Ranbaxy's failure to obtain timely tentative approval". The US FDA could not be reached for a comment.
If Mylan wins
If the court decides in favor of Pittsburg-based Mylan, this could be a setback to Ranbaxy's sales of $187 million that could have been gained from selling this blockbuster hypertension drug.