Depomed sues FDA over 'additional hurdles' to orphan exclusivity

Depomed won FDA approval for its shingles-pain drug Gralise under the agency's Orphan Drug program. Now, the company wants the Orphan Drug exclusivity to go along with it.

The company sued FDA, asking the court to order the agency to grant Gralise Orphan Drug exclusivity for managing post-herpetic neuralgia, otherwise known as shingles-related pain. That exclusivity would protect Gralise from generic competition through January 28, 2018, or 7 years after its approval.

Gralise, Depomed's branded version of gabapentin, won orphan designation in November 2010 for management of shingles pain. The drug won approval for that use in January 2011. Depomed says it believes it's entitled to that 7 years of exclusivity under the law governing FDA's Orphan Drug program and the agency's own regulations.

The problem is, gabapentin itself is an off-patent drug, available for cheap from several generics makers. Developed by Pfizer ($PFE) and sold for years under the Neurontin brand for epilepsy and other uses, the drug was originally FDA approved in 1994 as a seizure treatment, and won FDA approval for shingles pain in 2002.

Gralise is a once-daily formulation of gabapentin. As the FDA Law Blog notes, FDA told Depomed that, to gain marketing exclusivity, the company would have to prove that Gralise is clinically superior to the previously approved gabapentin. Depomed disputes FDA's authority to put up "additional hurdles" for Gralise.

"Though we and the FDA have different perspectives on the statute and regulations relevant to orphan drug exclusivity for Gralise, we very much appreciate the FDA's consideration of our views," CEO James Schoeneck said in a release.  "We filed this suit to ensure we have the opportunity to fully articulate our legal arguments in court."

- read the release from Depomed
- get more from Reuters

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