Momenta Pharmaceuticals, Inc. (MNTA)

[alertmeipp]

>>Not so fast....I don't believe the FDA takes into consideration legal issues when considering approval of a drug....

I believe they can get a tentative one which may or may not trigger a settlement talk with Teva...


See this:

http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm296039


When will the generic version of my medicine be available?
The availability of generic drug depends on many factors, including patent expiration and FDA approval of the generic drug application.

Each drug may hold several patents. The availability of generic versions depends on the court ruling of the validity of any pertinent patents and the expiration dates. FDA publishes the Orange Book. The Orange Book lists the patent number and expiration date of each patent that claims the drug or method of using the drug.

Each drug may have multiple patents, and not all patents are listed in the Orange Book. For example, drugs may have patents that are listed with the U.S. Patent and Trademark Office, but are not required to be listed in the Orange Book.

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.