Judge Says Marketing Exclusivity Begins With FDA Sign-Off on Drug

A federal judge agreed with the FDA’s interpretation that marketing exclusivity begins with NDA approval — and not the date of controlled substance scheduling — rejecting Eisai’s bid to restore exclusivity for two of its drugs.

In granting the FDA’s motion for summary judgment, the judge said “the exclusivity period for a new drug begins when the FDA issues its letter approving the drug, even if the drug’s manufacturer must await [the Drug Enforcement Agency’s] scheduling determination before it can bring the drug to market.”  

The decision comes as the Senate HELP Committee passed legislation that would extend exclusivity periods for new drugs by changing the date on which they are considered to have been approved from FDA sign-off to when DEA schedules them. The bill passed in the House in March, and is expected to be approved by the full Senate (DID, Oct. 2).

The Japanese drugmaker had claimed the agency wrongly triggered periods of five-year exclusivity by using the NDA approval dates instead of the dates the drugs could be marketed legally.

Eisai filed the lawsuit in August 2014 after the FDA refused to extend the exclusivity periods for Belviq (lorcaserin HCl) and Fycompa (perampanel), approved in June and October 2012 but not scheduled for more than a year later — in June 7, 2013, and Jan. 2, 2014, respectively.

Eisai contended that marketing exclusivity should have been triggered by the DEA scheduling dates because the FDA’s approval letters required label revisions before the products could be sold. — Kellen Owings

$1,695 $1,395


Start your one-year subscription (250 issues) to Drug Industry Daily for just $1,395*, a $300 savings off the regular price of $1,695. Plus, get a FREE copy of our webinar Understanding CDER's "Super" Office of Pharmaceutical Quality and Its Effect on You, usually $287

Key Benefits

LINKS TO KEY DOCUMENTS — You get links to key documents that support DID's articles such as draft and final guidances, 483s and warning letters, proposed rules, closeout letter, full text of proposed legislation and GAO reports.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.