Sun Pharmaceuticals Industries Ltd. can hold on to its six months of market exclusivity for a generic version of GlaxoSmithKline PLC's beta blocker Coreg CR.
The Food and Drug Administration told the company it didn't forfeit a financially lucrative six-month exclusivity period when its predecessor, Mutual Pharmaceutical Co., failed to obtain tentative approval for Coreg CR within the required 30 months. Mutual's failure to obtain tentative approval within the required time frame, the agency said, wasn't Mutual's fault but instead was caused by an eleventh-hour change in testing requirements for the product.
Mutual’s (now Sun’s) generic drug application was pending for 10 years without securing final FDA approval.
The FDA’s decision “shows that a first applicant can preserve its exclusivity even when quite a lot of time has passed,” Chad A. Landmon of Axinn, Veltrop & Harkrider LLP in Hartford, Conn., who represented Mutual, told me April 17.
Because the most recent annual U.S. sales for branded Coreg CR were $208 million and because market uptake of cheaper generics is usually quick, the FDA's decision will be a financial boon to Sun. The FDA's exclusivity decision means Sun’s product can be the only generic on the market for six months after it launches.
Other potential generic competitors such as Impax Laboratories Inc. will have to wait until Sun's exclusivity period runs out. Currently, the FDA has granted only tentative (not final) approval to Impax for its generic version of Coreg CR.
But Sun could face some competition if GSK decides to launch an authorized generic version of the drug that could compete with Sun's generic and stem GSK's losses from generic entry. Authorized generics are generic drug products introduced by branded companies, either directly or through partnering arrangements with other generic companies.
Carvedilol is used to treat high blood pressure and heart failure. It can also reduce the risk of death after a heart attack.
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