In a significant ruling favoring generic palyers,a German court has allowed generic launch of Clopidogrel besylate. This ruling will led Cimex AG, Schweizerhall and Novartis to launch this product in Germany and subsequently into the European market. Innovator Sanofi-Aventis and its U.S. partner Bristol-Myers Squibb announced that they would challenge a German court's decision to immediately authorize marketing of the generic versions of their blockbuster blood thinner Plavix (Clopidogrel). The generic players intend to launch this product by different salt. The approved salt is Clopidogrel bisulfate and generic will launch their product with Clopidogrel BesylateEarlier news of Ippharmadoc on this issue Here, Here, and Here
Wednesday, 30 July 2008
Cinacalcet (Sensipar): Barr confirms Para IV Challenge to innovator's patents
Barr Pharma has challenged four orange book listed patents held by Amgen Inc. for its Cinacalcet or Sensipar (30, 60 and 90 mg tablets), used by dialysis patients to treat side-effects of the treatment. Innovator Amgen got approval on this product on Mar 8, 2004. Following are the Orange Book listed patents on this product:
US6011068 (Expiry: Dec 14, 2016)- Link
US6031003 (Expiry: Dec 14, 2016) Link
US6211244 (Expiry: Oct 23, 2015) Link
US6313146 (Expiry: Dec 14, 2016) Link
Sensipar or Cinacalcet (N-[(1R)-1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine) acts as a calcimimetic by allosteric activation of the calcium-sensing receptor that is expressed in various human organ tissues. It is sold by Amgen under the trade name Sensipar in North America and Australia and as Mimpara in Europe. Cinacalcet is used to treat hyperparathyroidism (elevated parathyroid hormone levels), a consequence of parathyroid tumors and chronic renal failure.
Barr said it filed ANDA with Para IV certification against Orange Book listed patents on Cinacalcet on March 10, 2008.
Sensipar recorded $377 million in U.S. sales during the 12 months ending May, Barr said.
US6011068 (Expiry: Dec 14, 2016)- Link
US6031003 (Expiry: Dec 14, 2016) Link
US6211244 (Expiry: Oct 23, 2015) Link
US6313146 (Expiry: Dec 14, 2016) Link
Sensipar or Cinacalcet (N-[(1R)-1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine) acts as a calcimimetic by allosteric activation of the calcium-sensing receptor that is expressed in various human organ tissues. It is sold by Amgen under the trade name Sensipar in North America and Australia and as Mimpara in Europe. Cinacalcet is used to treat hyperparathyroidism (elevated parathyroid hormone levels), a consequence of parathyroid tumors and chronic renal failure.
Barr said it filed ANDA with Para IV certification against Orange Book listed patents on Cinacalcet on March 10, 2008.
Sensipar recorded $377 million in U.S. sales during the 12 months ending May, Barr said.
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