FDA Comes to Different Conclusions on 180-Day Exclusivity Tentative Approval Forfeiture Provision – Punts in One Case and Decides in Another
Last year, in our post titled “180-Day Exclusivity Forfeiture - A Zen Moment,” we reported on a case in which FDA took a stance with respect to the forfeiture of 180-day exclusivity eligibility that is reminiscent of the old “if a tree falls in the woods and nobody is there” enigma. That case concerned Sandoz’s ANDA #76-969 for Metoprolol Succinate Extended-Release Tablets, 25mg, which was submitted to FDA in December 2003. Sandoz was a “first applicant” eligible for 180-day exclusivity based on its Paragraph IV certification to a patent listed in the Orange Book covering the Reference Listed Drug (“RLD”), TOPROL-XL.
In July 2006, FDA granted full approval for the 25mg drug product, but noted that Sandoz failed to obtain tentative approval within 30 months after the date on which the ANDA was filed, and might therefore not be eligible for 180-day exclusivity. Under FDC Act § 505(j)(D)(5)(i)(IV), as amended by the Medicare Modernization Act:
The first applicant [forfeits 180-day exclusivity eligibility if the applicant] fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.
Ultimately, FDA punted on the issue, and stated in the ANDA approval letter that “the agency is not making a formal determination at this time of Sandoz’s eligibility for 180-day generic drug exclusivity. It will do so only if another applicant becomes eligible for approval within 180 days after Sandoz begins commercial marketing Metoprolol Succinate Extended-Release Tablets USP, 25 mg.”
Over the past several weeks, FDA has been faced with two similar situations concerning FDC Act § 505(j)(D)(5)(i)(IV). In one case FDA used language similar to that stated in the Sandoz ANDA approval letter. In another case FDA made clear its determination that 180-day exclusivity eligibility was forfeited.
In the case of Perrigo R&D Co.’s ANDA #77-355 for a generic version of PEPCID COMPLETE (famotidine, 10mg; calcium carbonate, 800mg; magnesium hydroxide, 165 mg) Chewable Tablets, Perrigo was a “first applicant” based on the company’s Paragraph IV certification to 3 Orange Book-listed patents. The ANDA was submitted to FDA in October 2004. According to FDA’s February 2008 approval letter, “Perrigo failed to obtain tentative approval of this ANDA within 30 months of the date on which the ANDA was filed . . . . However, the agency is not making a formal determination at this time of Perrigo’s eligibility for 180-day generic drug exclusivity. It will so only if another applicant becomes eligible for approval within 180-days after Perrigo begins commercial marketing” of the drug product approved under ANDA #77-355.
In the case of Watson Laboratories, Inc’s ANDA #77-219 for a generic version of CAMPTOSAR (irinotecan HCl) Injection, 20mg/mL, Watson was the first applicant to submit a submit a substantially complete ANDA with a Paragraph IV certification to an Orange Book-listed patent covering CAMPTOSAR. As such, the company was eligible for 180-day exclusivity. Watson submitted ANDA #77-219 to FDA in July 2004, and FDA tentatively approved the application in May 2007 – about 34 months after the date on which the application was filed. In contrast to the two previous cases cited above, FDA’s February 20, 2008 approval letter to Watson states:
The ANDA filing date plus 30 months was January 26, 2007; therefore, this ANDA was not granted tentative approval within the 30-month period described in section 505(j)(D)(5)(i)(IV). We also have determined that the requirements for approval of this ANDA were not changed or reviewed after your ANDA was filed . . . . We therefore conclude that the 180-day exclusivity period . . . for Irinotecan Hydrochloride Injection, 20 mg/mL, was forfeited by Watson.
FDA’s decision that Watson forfeited 180-day exclusivity eligibility was almost certainly prompted by the fact that several generic applicants that would have been subject to Watson’s 180-day exclusivity were pending and ready for approval. Indeed, on February 27, 2008, just a few days after approving Watson’s ANDA, FDA approved 7 ANDAs for generic Irinotecan HCl Injection drug products.
FDA’s decision in the Watson case should put to rest any speculation based on the Agency’s previous letters that FDA will determine that a “first applicant” has not forfeited 180-day exclusivity eligibility if tentative approval was not granted within 30 months of the date on which the ANDA was filed and there are other ANDAs in the approval queue.
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