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Generated: January 21, 2018

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Details for Patent: 6,635,280

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Summary for Patent: 6,635,280
Title: Extending the duration of drug release within the stomach during the fed mode
Abstract:Drugs are formulated as unit oral dosage forms by incorporating them into polymeric matrices comprised of hydrophilic polymers that swell upon imbibition of water to a size that is large enough to promote retention of the dosage form in the stomach during the fed mode. The oral formulation is designed for gastric retention and controlled delivery of an incorporated drug into the gastric cavity, and thus administered, the drug is released from the matrix into the gastric fluid by solution diffusion. The swollen polymeric matrix, having achieved sufficient size, remains in the gastric cavity for several hours if administered while the patient is in the fed mode, and remains intact long enough for substantially all of the drug to be released before substantial dissolution of the matrix occurs. The swelling matrix lowers the accessibility of the gastric fluid to the drug and thereby reduces the drug release rate. This process, together with diffusion retardation by selection of specific polymers, polymer molecular weights, and other variables, results in a sustained and controlled delivery rate of the drug to the gastric cavity.
Inventor(s): Shell; John W. (Hillsborough, CA), Louie-Helm; Jenny (Union City, CA), Markey; Micheline (Santa Cruz, CA)
Assignee: DepoMed, Inc. (Menlo Park, CA)
Application Number:10/045,823
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Use;

Drugs Protected by US Patent 6,635,280

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 AB3 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Depomed Inc PROQUIN XR ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744-001 May 19, 2005 DISCN No No ➤ Subscribe ➤ Subscribe Y THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS ➤ Subscribe
Depomed Inc GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Depomed Inc GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 6,635,280

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,340,475 Extending the duration of drug release within the stomach during the fed mode ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 6,635,280

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 302597 ➤ Subscribe
Australia 729529 ➤ Subscribe
Australia 8138698 ➤ Subscribe
Canada 2290624 ➤ Subscribe
Canada 2364845 ➤ Subscribe
Germany 69831335 ➤ Subscribe
European Patent Office 0998271 ➤ Subscribe
Spain 2248908 ➤ Subscribe
Hong Kong 1027298 ➤ Subscribe
Japan 2000513028 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Teva
Chinese Patent Office
Healthtrust
Daiichi Sankyo
Boehringer Ingelheim
AstraZeneca
QuintilesIMS

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