The Latest in FDA Evaluations and Research

FDA News


Related Topics: FDA News

News Feed Item

Depomed Summary Judgment Motion Granted in Suit against FDA Seeking Orphan Drug Exclusivity for Gralise® (Gabapentin)

NEWARK, Calif., Sept. 5, 2014 /PRNewswire/ -- Depomed, Inc. (Nasdaq:DEPO) today announced that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted Depomed's motion for summary judgment in the company's lawsuit against the United States Food and Drug Administration seeking an order requiring the FDA to grant Gralise® (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN). 

The court's ruling requires that the FDA grant Orphan Drug exclusivity for Gralise for the management of PHN.   

"We are pleased with the court's ruling," said Jim Schoeneck, Depomed's President and Chief Executive Officer. "With Orphan Drug exclusivity and the recently announced victory in our Gralise patent litigation against Actavis blocking generic Gralise until 2024, we expect Gralise to benefit from nearly an additional decade of commercial exclusivity."

About Depomed

Depomed is a specialty pharmaceutical company that commercializes products for pain and CNS disorders.  Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia.  CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older).  Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults.  Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.  Gralise and various partner product candidates are formulated with Depomed's proven, proprietary Acuform® drug delivery technology.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995.  The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our expectations regarding the period of commercial exclusivity for Gralise and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2013 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2014 and June 30, 2014.  The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

INVESTOR CONTACT:
August Moretti
Depomed, Inc.
510-744-8000

MEDIA CONTACT:
Jason I. Spark
Canale Communications for Depomed
619-849-6005
[email protected]

SOURCE Depomed, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.