Replies to post #9166 on Momenta Pharmaceuticals, Inc. (MNTA)

[pollyvonwog]

So even if MNTA had won, it would of been a tentative approval with all the appeals right?

[vinmantoo]

alertmeipp,

<The availability of generic versions also depends on whether generic applications for approval are submitted to FDA, and whether these applications contain sufficient information for approval. If a generic drug product is ready for approval before the expiration of any patents, FDA issues a tentative approval letter to the applicant. A tentative approval does not allow the applicant to market the generic drug product.

FDA delays final approval of the generic drug product until all patent issues are resolved.>

Since MNTA will appeal, are you saying the FDA won't make any decisions until after their appeal is heard? If MNTA will the appeal, won't TEVA file an injunction? Weren't there issues with the Enoxaparin patents at the time when FDA gave approval to mEnox? It seems to me that the FDA shouldn't consider the legal aspects of any drug but let the companies fight it out with lawyers.

[DewDiligence]

FDA delays final approval of the generic drug product until all patent issues are resolved.

This should read: “FDA delays final approval of the generic drug product until all patent issues are resolved or there is a Paragraph-IV challenge and the 30-month Hatch-Waxman stay has expired.”

Please see my reply to rwwine in #msg-76904920.