Orange Book Blog

Ondansetron Update: Apotex Loses Emergency Appeal, Dr. Reddy's Launches Generic Zofran

We previously reported on Apotex's lawsuit against the FDA concerning generic Zofran (ondansetron HCl) tablets.  Apotex sought an injunction directing FDA to approve Apotex's ANDA for generic Zofran tablets when GlaxoSmithKline's pediatric exclusivity on Zofran expired on December 24, 2006.  Although Dr. Reddy's was the first to file an ANDA for generic Zofran tablets, Apotex argued that a May 2005 district court dismissal of GSK's lawsuit against Apotex triggered Dr. Reddy's 180-day exclusivity period, which then ran to completion in December 2005.

On December 7, 2006, Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia denied Apotex's motion for a preliminary injunction against the FDA, prompting Apotex to file an emergency motion to stay the district court's order pending appeal.  On December 22, the D.C. Circuit Court of Appeals denied Apotex's motion.  That cleared the way for FDA to grant final approval for ondansetron HCl tablets to Dr. Reddy's, which it did on December 27.  The same day, Dr. Reddy's announced that it would "commence the shipment of this product shortly."

Zofran, which is indicated for the prevention of nausea and vomiting associated with chemotherapy, is available in several different dosage forms and strengths.  Besides granting final approval to Dr. Reddy's, FDA announced in November that it granted final approval to Teva and SICOR for generic Zofran Injection and Zofran Injection Premixed.  Additionally, FDA announced in December that it granted final approval to Kali Laboratories' ANDA for generic Zofran ODT (ondansetron orally disintegrating tablets) and to Roxane Laboratories' ANDA for generic Zofran Oral Solution.  The various forms of Zofran accounted for well over $1 billion in sales last year for GSK.

Meanwhile, it appears that Apotex's lawsuit against the FDA is moving forward.  On January 18, the FDA and Dr. Reddy's answered Apotex's complaint.  Today, the court set a March date for the initial scheduling conference.  With Dr. Reddy's already on the market as the sole generic supplier of ondansetron HCl tablets, it is unclear what Apotex has to gain by pursuing the case.

Apotex Sues FDA Over Decision on Generic Zofran, Challenging FDA's Interpretation of "Court Decision" Trigger Again

Apotex filed a complaint and motion for preliminary injunction against the FDA in the U.S. District Court for the District of Columbia last week, alleging that the FDA unlawfully refused to acknowledge that the dismissal of its patent infringement suit against GlaxoSmithKline over generic Zofran was a "court decision" triggering the first ANDA filer's 180 day period of exclusivity.  The dismissal order was entered May 25, 2005, and therefore Apotex claims that the 180 day exclusivity period expired in November, 2005.  Apotex would like to launch its generic Zofran next month, when the last of GSK's patents expire.  Unless the FDA changes its position, however, Apotex will have to wait until at least 180 days later.

Apotex had previously challenged the FDA's interpretation of a "court decision" sufficient to trigger a 180 day exclusivity period, in a declaratory judgment action involving generic Pravachol.  In that case, FDA decided that the dismissal of a patent suit was not such a court decision; instead, a court must issue a holding on the merits of the suit.  FDA explained in a November 3rd letter to counsel for Apotex that its "holding-on-the-merits" standard "is equally applicable to affirmative patent suits," such as the Zofran case.  Apotex filed its lawsuit against the FDA shortly after receiving the letter.

The impact of this case will be relatively limited because the Medicare Modernization Act of 2003 got rid of the "court decision" trigger entirely.  For ANDAs filed after December 8, 2003, if no other ANDAs containing a paragraph IV certification for the listed drug were filed prior to December 8, 2003, a court decision no longer triggers the 180-day exclusivity period.  Instead, the exclusivity period does not begin until the first commercial marketing of the generic drug.

NOTE:  Thanks to Kurt Karst for bringing this case to my attention.