FDA has once again determined that an ANDA sponsor forfeited 180-day market exclusivity by failing to get tentative approval within 30 months after filing an application. This time around Teva Pharmaceuticals USA Inc. lost exclusivity for its generic version of Allergan PLC’s osteoporosis drug Actonel (risedronate).

While such decisions often lead to fierce battles with FDA, Teva has so far taken this one in stride. In a June 10 memorandum to Teva explaining its decision the agency noted that Teva had not submitted any correspondence regarding its eligibility for 180-day exclusivity for the product. The company said it had no comment on FDA’s decision at this time.

But in a Sept. 1 post on the FDA Law Blog, Kurt Karst, of Hyman, Phelps & McNamara, noted the significance of the decision, saying it “hammers home the agency’s ‘our failure is your failure position.’”

The Medicare Modernization Act includes several provisions under which an ANDA applicant can lose 180-day exclusivity, one of which is the failure to obtain tentative approval within 30 months of submission of an ANDA. The statute provides an exception if the failure is “caused by a change in or review of the requirements for approval of the application imposed after the date on which the application is filed.”

“The statute does not permit, let alone require, either FDA or an ANDA applicant to comb through the ANDA review records and decide whether, had the review been conducted more quickly, the application could have received tentative approval before the 30-month forfeiture date,” the agency told Teva.

The 30-month deadline from Teva’s submission for an ANDA for 150 mg risedronate was Feb. 12, 2011. FDA said that final review of its ANDA by Office of Generic Drugs management was not complete until Aug. 17, 2011. The agency asserted that a company cannot get around forfeiture by claiming the possibility that FDA’s delays caused the company’s failure to obtain tentative approval by the 30-month date.

“The statute does not permit, let alone require, either FDA or an ANDA applicant to comb through the ANDA review records and decide whether, had the review been conducted more quickly, the application could have received tentative approval before the 30-month forfeiture date,” the agency told Teva.

“To avoid forfeiture, an applicant need only show that acceptability of one aspect of the ANDA (e.g., chemistry) was delayed due, at least in part, to a change in or review of the requirements for approval, irrespective of what other elements may also have been outstanding at the 30-month date,” FDA said.

Karst noted the difficulty in challenging FDA’s position that its delay in granting tentative approval does not prevent a company from losing exclusivity.

“We’ve always found FDA’s ‘our failure is your failure position’ problematic from a fairness standpoint; however, no company has yet taken FDA to task in a lawsuit challenging the agency’s interpretation and application of the position,” he wrote. “That’s probably because finding the perfect case is very difficult. After all, what ANDA file is clean enough from a response timeframe to make such a challenge?”

FDA Sometimes Takes The Blame

Teva’s loss of exclusivity as first ANDA filer benefitted Mylan NV, which on June 11 announced the launch of its generic version of 150 mg Actonel. The company noted that, according to IMS Health, the drug had U.S. sales of approximately $171.6 million for the 12 months ending March 31.

Actavis acquired Actonel with its acquisition of Warner Chilcott PLC last year. The drug had blockbuster sales of $1 billion in 2010 but revenue declined sharply due to patent expirations in Canada and Western Europe and FDA concerns about the safety of bisphosphonates to treat osteoporosis Also see "Tax Benefits, Branded Portfolio, Synergies Drive Actavis’ Acquisition of Warner Chilcott" - Pink Sheet, 27 May, 2013..

Other companies have previously challenged FDA forfeiture decisions, particularly in cases where the agency found sponsors qualified for an exception to forfeiture.

Lupin Pharmaceuticals Inc. objected to FDA’s finding that Teva had not forfeited 180-day exclusivity for its generic version of Sanofi-Aventis US LLC’s blood pressure medication Avapro (irbesartan). Although Teva failed to obtain tentative approval within 30 months from filing FDA said it changed the approval requirements for Teva’s drug, providing an exception to forfeiture Also see "Teva’s Generic Irbesartan Deserves 180-Day Exclusivity Because Of Review Delays, FDA Says" - Pink Sheet, 6 April, 2012..

And Mylan unsuccessfully sued FDA for its decision that Ranbaxy Laboratories Ltd. had not forfeited exclusivity for a generic version of Novartis AG’s Diovan (valsartan). The agency concluded that the publication of a new USP monograph caused Ranbaxy’s failure to obtain tentative approval within 30 months Also see "Diovan Generic Exclusivity Mystery Deepens After Judge Tosses Mylan Lawsuit" - Pink Sheet, 28 December, 2012..

Teva Loses 180-Day Exclusivity For Generic Actonel As FDA Stands Firm On Review Delays

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