FDA Rejects Vanda Pharmaceuticals Efforts to Force ANDA-Filers to Include Labeling Statements Related to its Three-Year Exclusivity

Last week, the FDA rejected Vanda Pharmaceutical’s Citizen Petition requesting that FDA withhold approval of ANDAs for its schizophrenia drug, Fanapt®, for three years.  (Letter from Janet Woodcock, M.D., Director Center for Drug Evaluation and Research, to Richard L. Gulino, Senior Vice President, General Counsel and Secretary, Vanda Pharmaceuticals Inc., dated Nov. 28, 2016.)  Specifically, […]

Biosimilar Applicants Cannot Avoid 180-Day Notice Requirement

Companies currently holding the exclusive rights to biologics should be celebrating the Federal Circuit’s decision released earlier this week.  In Amgen v. Apotex, the Court held that all biosimilar applicants must provide a 180-day notice to owners of the NDA for the referenced biologic before engaging in commercial marketing of their biosimilars.  Amgen Inc. v. […]

Federal Circuit Extends Biologic Exclusivity by 180 Days Gives Biosimilars A Choice Whether to Disclose Product Information Required by the BPCIA

The Federal Circuit handed down a decision interpreting the Biologics Price Competition and Innovation Act (BPCIA) in a way that effectively grants branded biologics an additional six months of exclusivity.  However, in a win for biosimilar applicants, the Federal Circuit also held that the statutory directive to disclose abbreviated application and manufacturing information to the […]

Federal Circuit Clarifies Scope of § 271(e) Safe Harbor in Classen v. Elan

In Classen Immunotherapies, Inc. v. Elan Pharms., Inc., the Federal Circuit determined that an NDA-holder’s post-approval activities fall within the scope of the § 271(e) safe harbor.  2015 U.S. App. LEXIS 7854 (Fed. Circ. May 13, 2015).  Specifically, 35 U.S.C. § 271(e)(1) exempts activities reasonably relating to developing clinical data on an approved drug and submitting that […]

Court Permits FDA to Carve Out Indications, Despite Brand Name’s Orphan Drug Status

A United States District Court has decided generic versions of aripiprazole (Abilify®) may proceed to market despite the brand name drug’s orphan drug status.  On April 28, 2015, the FDA approved four generic versions of aripiprazole (Abilify®), which is marketed and sold by Otsuka America Pharmaceutical, Inc.  Otsuka sought a temporary restraining order that would […]

FDA Issues Draft Guidance on NCE Exclusivity for Combination Products

The U.S. Food and Drug Administration (“FDA”) recently issued Draft Guidance to the Industry, titled “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products,” that proposes a change in its longstanding policy concerning 5-year new chemical entity (“NCE”) exclusivity for fixed-combination drug products.  For many years, FDA’s interpretation of the word “drug” in certain provisions […]