Innovator Daiichi has got 6 months pediatric exclusivity for Olmesartan and it's combination products in US market.
The Orange Book patents would expire on following revised dates:
US5616599 (Expiry:Oct 25, 2016): Which covers Olmesartan as product
US6878703 (Expiry:May 19, 2022): which covers combination of Olmesartan with HCTZ
In the light of above extension, the generic version would be delayed by 6 months.
The generic for Olmesartan tablets (Benicar) would be expected after Oct 25, 2016.
The generic version for Olmesartan+ Amlodipine (AZOR) formulations would be expected after Oct 25, 2016.
Further, Olmesartan+Hydrochlorthiazide (Benicar HCT) would be expected after May 19, 2022
Thursday, 22 October 2009
Olmesartan (Benicar), Olmesartan+Hydrochlorthiazide (Benicar HCT) and Olmesartan+ Amlodipine (AZOR) formulations: Innovator got Pediatric exclusivity
Posted by ADKS at 1:01 pm
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