MENLO PARK, Calif.--(BUSINESS WIRE)--Nov. 10, 2009--
Depomed, Inc. (NASDAQ:DEPO) today announced that it has received a
Paragraph IV certification notice from Lupin Limited advising Depomed of
the filing of an Abbreviated New Drug Application (ANDA) with the FDA
for a generic version of GLUMETZA® (metformin hydrochloride extended
release tablets), 500 mg and 1000 mg strengths.
Lupin’s certification notice alleges that Depomed’s U.S. Patents (Nos.
6,340,475; 6,488,962; 6,635,280; and 6,723,340) listed in the FDA Orange
Book for GLUMETZA are invalid and/or will not be infringed by Lupin’s
commercial manufacture, use or sale of the products described in Lupin’s
ANDA.
U.S. Patent No. 6,340,475 will expire in 2016, U.S. Patent No. 6,488,962
will expire in 2020, U.S. Patent No. 6,635,280 will expire in 2016 and
U.S. Patent No. 6,723,340 will expire in 2021.
Depomed is evaluating the Paragraph IV certification and continues to
have full confidence in the intellectual property protecting GLUMETZA.
Depomed has 45 days from the receipt of the Paragraph IV certification
to commence a patent infringement lawsuit against Lupin that would
automatically stay, or bar, the FDA from approving Lupin’s ANDA for 30
months or until a district court decision that is adverse to the
company, whichever is earlier.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one product
candidate through Phase 3 clinical development, another in Phase 3
clinical development, two approved products on the market and other
product candidates in its early stage pipeline. Product candidate
DM-1796 has completed Phase 3 clinical development and has been licensed
to Solvay Pharmaceuticals. A New Drug Applications for DM-1796 is
expected to be filed with the FDA in the first quarter of 2010. Product
candidate SeradaTM is in Phase 3 clinical development for
menopausal hot flashes. GLUMETZA(R) (metformin hydrochloride
extended release tablets) is approved for use in adults with type 2
diabetes and promoted by Santarus, Inc. in the United States. Depomed
formulates its products and product candidates with its proven,
proprietary Acuform(R) drug delivery technology, which is
designed to improve existing oral medications, allowing for extended,
controlled release of medications to the upper gastrointestinal tract.
Benefits of Acuform-enhanced pharmaceuticals include the convenience of
once-daily administration, improved treatment tolerability and enhanced
compliance and efficacy. 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 potential patent
litigation related to our GLUMETZA product;; our research and
development efforts, including pre-clinical and clinical testing;
regulation by the FDA and other government agencies; the timing of
regulatory applications and product launches; 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. 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.
Source: Depomed, Inc.
Depomed, Inc.
Sheilah Serradell, 650-462-5900
sserradell@depomed.com
