FDA denies Citizen Petition on generic Combivir 180-day exclusivity 'First Applicant' issue

Last week, in a seven-page response, the US Food and Drug Administration denied an October 18, 2010 Citizen Petition submitted on behalf of Indian drugmaker Lupin (LOPN: BO requesting that FDA determine that Teva Pharmaceuticals USA, a unit of Israeli generics giant Teva Pharmaceutical Industries (Nasdaq: TEVA) Abbreviated New Drug Application No 79-081 for a generic version of Combivir (lamivudine and zidovudine) capsules, and that contains the first Paragraph IV certification to an Orange Book-listed patent on the Reference Listed Drug (RLD), is not eligible for 180-day exclusivity.

In its response, the FDA affirms that the plain language of the definition of a “first applicant” at FDC Act No 505(j)(5)(B)(iv)(II)(bb) as added by the 2003 Medicare Modernization Act (MMA) simply requires a Paragraph IV certification, regardless of what Orange Book-listed patent that certification concerns, comments Kurt Karst on the FDA Law Blog, the official blog of law firm Hyman, Phelps & McNamara.

Combivir is listed in the Orange Book with two unexpired patents - US Patent No 5,859,021, which expires on May 15, 2012, and US Patent No 5,905,082, which expires on May 18, 2016 and is subject to a period of pediatric exclusivity that lapses on November 18, 2016. Teva submitted ANDA No 79-081 to the FDA on June 26, 2007 containing a Paragraph IV certification to the earlier-expiring ‘021 Patent, and a Paragraph III certification to the later-expiring ‘082 Patent. In October 2008, Teva reportedly amended its ANDA to contain a Paragraph IV certification to the ‘082 Patent. In the meantime, Lupin submitted an ANDA in January 2008 containing Paragraph IV certifications to both the ‘021 and ‘082 patents.