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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,340,475

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Which drugs does patent 6,340,475 protect, and when does it expire?


Patent 6,340,475 protects GLUMETZA, JANUMET XR, JENTADUETO XR, PROQUIN XR, and GRALISE, and is included in five NDAs. There have been zero Paragraph IV challenges on Janumet XR, , and Gralise.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 6,340,475

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:09/282,233
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005AB3RXYesNo► Subscribe► Subscribe► SubscribeYYINDICATION OF TYPE II DIABETES
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo► Subscribe► Subscribe► SubscribeY
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes► Subscribe► Subscribe► SubscribeY
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo► Subscribe► Subscribe► SubscribeY
Boehringer IngelheimJENTADUETO XRlinagliptin; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING TYPE 2 DIABETES
Boehringer IngelheimJENTADUETO XRlinagliptin; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYesYes► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING TYPE 2 DIABETES
Depomed IncPROQUIN XRciprofloxacin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021744-001May 19, 2005DISCNNoNo► Subscribe► Subscribe► SubscribeYTHE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
Depomed IncGRALISEgabapentinTABLET;ORAL022544-001Jan 28, 2011BXRXYesYes► Subscribe► Subscribe► SubscribeY
Depomed IncGRALISEgabapentinTABLET;ORAL022544-002Jan 28, 2011BXRXYesYes► Subscribe► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 6,340,475

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
6,635,280 Extending the duration of drug release within the stomach during the fed mode► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 6,340,475

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria302597► Subscribe
Australia729529► Subscribe
Australia8138698► Subscribe
Canada2290624► Subscribe
Canada2364845► Subscribe
Germany69831335► Subscribe
European Patent Office0998271► Subscribe
Spain2248908► Subscribe
Hong Kong1027298► Subscribe
Japan2000513028► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Argus Health
Medtronic
Harvard Business School
Fish and Richardson
Cipla
Accenture
Covington
Dow
Citi
Fuji

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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