Actavis Sues FDA Over VYVANSE Exclusivity; Action Challenges FDA’s NCE Exclusivity Policies

March 1, 2009

By Kurt R. Karst –     

Actavis Elizabeth LLC (“Actavis”) has sued FDA after the Agency refused to accept the company’s ANDA for a generic version of the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules earlier this year.  FDA’s Orange Book shows that VYVANSE is a Type 1 new molecular entity covered by a period of 5-year New Chemical Entity (“NCE”) exclusivity, as well as another period of 3-year exclusivity and two patents scheduled to expire on June 29, 2023.  The VYVANSE labeling states that the drug product is a therapeutically inactive pro-drug that is metabolically converted to dextroamphetamine, a previously approved drug (e.g., ADDERALL).  According to the Actavis complaint, which was filed in the U.S. District Court for the District of Columbia, the company submitted an ANDA containing a Paragraph IV certification to FDA on January 28, 2009, and on February 6, 2009, FDA informed Actavis that the Agency refused to file the ANDA in light of FDA’s award of NCE exclusivity for VYVANSE.

Actavis is effectively challenging FDA’s policy on the availability of NCE exclusivity for metabolically converted drugs.  FDA stated in the preamble to the Agency’s 1989 proposed regulations implementing the Hatch-Waxman Amendments that:

A compound (other than an ester) that requires metabolic conversion to produce an already approved active moiety is considered a “new molecular entity,” . . . and will be considered a new chemical entity entitled to 5 years of exclusivity.  FDA will consider whether a drug contains a previously approved active moiety on a case-by-case basis.

FDA, Proposed Rule, ANDA Regulations, 54 Fed. Reg. 28,872, 28,898 (July 10, 1989). 

Actavis argues that FDA should not have granted 5-year NCE exclusivity for VYVANSE, and that “FDA’s blanket distinction between covalent derivatives and non-covalent derivatives for purposes of awarding NCE exclusivity is inconsistent with the FDCA, its legislative history and FDA’s own regulations.”  Actavis’ complaint requests that the court: (1) enter judgment declaring that FDA’s grant of NCE exclusivity for VYVANSE and refusal to accept the company’s ANDA is arbitrary, capricious and contrary to law; and (2) enter an injunction directing FDA to rescind the VYVANSE 5-year exclusivity and accept the Actavis ANDA as of January 28, 2009.   

Categories: Hatch-Waxman