Posted on the FDA Law Blog by Kurt Karst on June 19, 2014.
After years of relative quiet, the Orange Book list of exclusivity terms has gotten quite a workout over the past year with the addition of several new terms to account for new non-patent marketing exclusivities. First there was the addition of “NCE*” exclusivity, defined as “NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT),” that FDA created after the approval of NDA No. 204168 for FETZIMA (levomilnacipran) Extended-release Capsules, 20 mg, 40 mg, 80 mg and 120 mg (see our previous post here). Then there was the addition of “RTO*” and “RTO**” exclusivities, defined as “OTC USE FOR WOMEN AGES 15 AND 16” and “OTC USE FOR WOMEN 14 AND BELOW,” respectively, that FDA created to account for various supplemental approvals under NDA No. 021998 for PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (see our previous post here). Now that FDA has approved the first drug product designated as a Qualified Infectious Disease Product (“QIDP”), the Agency has once again added to the Orange Book list of exclusivity terms. The term “GAIN” was added to the Orange Book Cumulative Supplement last week in relation to NDA No. 021883 for DALVANCE (dalbavancin HCl) Lyophilized Powder for Injection, 500 mg. FDA approved DALVANCE on May 23, 2014 in the treatment of acute bacterial skin and skin structure infections. With a period of NCE exclusivity that expires on May 23, 2019, but that is extended under the Generating Antibiotic Incentives Now Act (“GAIN Act”) by an additional 5 years to May 23, 2024, the GAIN exclusivity FDA granted for DALVANCE is the latest expiring period of non-patent exclusivity ever listed in the Orange Book (not to mention the longest period of exclusivity that FDA has granted for a drug product in decades – see FDC Act § 505(j)(5)(F)(i)).
To see the full post, go to the FDA Law Blog.