Nexium First Generic Approved, 180-Day Exclusivity Issue Resolved?

I’m not quite sure what brought this long awaited generic approval to fruition but on January 26, 2015, the Office of Generic Drugs (OGD) issued approval for the product (see announcement here). Remember, there was an issue with the original tentative approval’s (TA) issuance on February 5, 2008, in that the TA letter had been issued in error due to issues related to cGMPs of the manufacturing facility when the TA was originally issued. FDA subsequently rescinded the TA on November 4, 2014 for that reason. Remember, the only time a TA letter can be issued is when the ANDA applicant has otherwise met all of the scientific and regulatory requirements for approval but for a period of patent or market exclusivity protection on the innovator product.  This means that the compliance status, according to FDA, should have been acceptable at the time of the original TA issuance, thus the apparent FDA error.

Our good friends at Hyman Phelps and McNamara have written a blog on this issue (here)  that further outlines some of the decision points the FDA might have considered in making its decision to approve the Teva (Ixax) ANDA, including an indirect inference in a Sandoz petition denial (here) on January 26, 2015 relating to an administrative matter on how Sandoz believes the 30-month period should be calculated.   The FDA Law Blog post and the petition denial make for good reading and can help one zero in on the FDA’s thinking relative to the January 26, 2015 of the first generic esomeprazole magnesium approval, which (by the way) happens to be one of the biggest generic approvals of one of the biggest products of all times.

Now we will have to see if there is any legal action to follow this approval.