Glenmark Generics announced (in a press release Here ) that the USFDA has granted tentative approval for the generic version of innovator Schering Plough and MSP Singapore Company LLC's hypercholesterolemia treatment Ezetimibe (Zetia) 10 mg tablets.
Also, innovator shering and MSP has sued Glenmark in New Jersey Disctrict Court for the infringement of following patent:
USRE37721(Expiry: April,25, 2017): which covers Ezetimibe as product
Also, there are two other non-litigated Orange Book listed patents which covers combination of Ezetimibe with other API’s. Earlier, Glenmark filed an Abbreviated New Drug Application (ANDA) on October 25, 2006 for this product.
Possibly, Glenmark is eligible for First Para IV filing 180 days exclusivity for this high margin product which achieved sales of USD 1.5 billion in 2008..
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