MENLO PARK, Calif., June 6, 2012 /PRNewswire/ -- Depomed, Inc. (NASDAQ:DEPO) today announced the issuance of a new patent expanding the patent estate around the company's Gralise® (gabapentin), Depomed's once-daily gabapentin product approved for the management of postherpetic neuralgia. The patent, United States Patent No. 8,192,756, expires in October 2022 and will be listed in the FDA "Orange Book" along with the six patents currently listed for Gralise.
"We are particularly pleased with the issuance of this new patent because it relates primarily to blood plasma bioavailability parameters of the claimed dosage form, and uniquely supplements the claims in our earlier Gralise patents," stated Jim Schoeneck, President and CEO of Depomed. "Our IP estate around Gralise is considerable, now with seven Orange Book listed patents providing protection into 2024, numerous defensive patents covering alternative formulation approaches and several additional applications in active prosecution." Mr. Schoeneck added, "Another example of our significant progress on the IP front came last week, with our receipt of a notice of allowance from the USPTO for an alternative formulation application (Ser. No 13/301,644) directed to certain gastroretentive gabapentin dosage forms that include a buoyant layer or, alternatively, gas-generating agents."
United States Patent No. 8,192,756
The patent, entitled "Gastric Retained Gabapentin Dosage Forms," includes a total of 30 claims, three of which are independent claims directed to once-daily or twice-daily gabapentin dosage forms and methods characterized by the bioavailability of gabapentin associated with the claimed dosage forms relative to immediate release gabapentin. The patent also covers Serada®, Depomed's investigational product under evaluation for the treatment of menopausal hot flashes.
Depomed, Inc. is a specialty pharmaceutical company with two approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
"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 the enforcement of intellectual property rights; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. 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.
August J. Moretti
SOURCE Depomed, Inc.