Generic Drugmaker Sues FDA to Get Its Exclusivity Back

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By Dana A. Elfin

Amneal Pharmaceuticals LLC wants a court to restore six months of market exclusivity for its generic version of the Alzheimer’s drug Namenda XR ( Amneal Pharmaceuticals LLC v. FDA , D.D.C., No. 1:17-cv-00180, complaint filed 1/27/17 ).

Amneal is challenging the FDA’s decision to strip it of its exclusivity rights in a suit filed in the U.S. District Court for the District of Columbia Jan. 27. It’s also asking the court to require the FDA to yank its approvals of other companies’ generics of the drug.

How the court decides the suit could shape how generic drug companies argue exclusivity forfeiture issues going forward, according to Chad A. Landmon, an intellectual property and food and drug law attorney.

“Depending upon how the Court comes out on the issue, it could either open up or foreclose opportunities for companies to make arguments regarding potential forfeiture issues going forward,” Landmon told Bloomberg BNA Feb. 1. Landmon is with Axinn, Veltrop & Harkrider LLP in Hartford, Conn., and Washington.

Amneal Qualified for Exclusivity

Because Amneal was the first applicant to file an abbreviated new drug application (ANDA) challenging the patents on four different dosages of Namenda XR (memantine HCl) extended-release capsules, it qualified for the valuable 180 days of market exclusivity on the generic drug.

But the Food and Drug Administration decided Amneal forfeited its exclusivity because it didn’t obtain tentative approval of its ANDA within 30 months of filing its application. The agency approved Amneal’s ANDA but also approved other generic companies’ ANDAs at the same time, negating Amneal’s right to be the only generic on the market.

To date, the FDA has granted final approval for generic versions of Namenda XR to Lupin Ltd., Mylan Pharmaceuticals Inc., Sun Pharma Global FZE and Apotex Inc.

FDA to Blame?

The FDA’s decision that Amneal forfeited its 180-day exclusivity is unlawful because the delay was partially caused by the FDA’s changes in or reviews of the approval requirements for the application, Amneal argued.

“Under a proper review of the record, evaluation of causation, and application of the FDCA [Food Drug and Cosmetic Act]’s requirements, Amneal is entitled to, and has not forfeited, 180-day exclusivity,” it said in the complaint.

The company said FDA’s forfeiture finding, and the approval of other companies’ ANDAs for Namenda XR, “are arbitrary, capricious, and contrary to law, and must be vacated.”

Interpreting Forfeiture Provision

Under the 2003 Medicare Modernization Act (MMA), generic drug companies can lose the valuable 180-day exclusivity for their generic drug if they don’t obtain tentative FDA approval of their abbreviated new drug application within 30 months after the date the application is filed.

But there’s an important exception to this forfeiture provision. If the company’s failure to obtain tentative approval is caused by a change in or a review of the requirements for approval after the ANDA was filed, there is no forfeiture.

The crux of Amneal’s case hinges on interpreting the causation language of the MMA.

ANDA Delays Common

Amneal’s ANDA experienced an extensive months-long delay resulting from changes in or reviews of the FDA’s approval requirements for the application, the complaint said, including the agency’s request for Amneal to provide data on commercial scale lots of the generic drug.

“It’s often the case that the ANDA review process involves multiple back-and-forths between the ANDA holder and FDA, which can slow down the review and approval of the ANDA,” Landmon said.

If the FDA’s delays contributed in any measure to Amneal’s failure to obtain tentative approval, forfeiture is unlawful, and the FDA’s decision to impose it arbitrary and capricious.

The plaintiff company said the FDA “should not impose forfeiture if, as a factual matter, there is any causal connection between the failure to obtain tentative approval and a change in or review of approval requirements for the application.”

Suit Presents Novel Issue

Amneal’s suit may be the first time a court has been asked to interpret this particular aspect of the MMA’s forfeiture provision.

“I am not aware of any other suits on this forfeiture requirement,” Terry G. Mahn, of Fish & Richardson in Washington, told Bloomberg BNA Feb. 1. Mahn practices primarily before the FDA, helping clients with technically complex product authorizations.

The causation issue is far from clear, Landmon said. “It’s certainly an interesting case and deals with a novel issue that the generic drug industry has been chewing on since the passage of the MMA,” he said. “We do not yet have much clarity on the causation requirement other than what FDA has said in its recent guidance and in periodic decisions with respect to certain ANDAs.”

Neither Mahn nor Landmon is involved in the case.

Odds of Winning Slim

Amneal’s chances of prevailing in its suit may be slim.

“The dispute appears to be very fact-based and that favors the agency,” Mahn said. “FDA determines what its review requirements are (and whether they were being reviewed for a change during the ANDA review period) and FDA determines whether its review of these requirements (to the extent there was a review) was a contributing factor in the approval delay.”

Showing the FDA acted arbitrarily and capriciously “is a tall hurdle for any plaintiff,” he said.

Judge Randolph D. Moss has been assigned to the case.

The law firm of Foley Hoag LLP in Boston and Washington represents Bridgewater, N.J.-based Amneal.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

The complaint is available at

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