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Details for Patent: 8,475,841

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Patent 8,475,841 protects ACTOPLUS MET XR and FORTAMET and is included in two NDAs. There have been zero Paragraph IV challenges on Actoplus Met XR and Fortamet

This patent has seventeen patent family members in nine countries.

Summary for Patent: 8,475,841

Title:Controlled release metformin formulations
Abstract: Sustained release pharmaceutical formulations comprising an antihyperglycemic drug or a pharmaceutically acceptable salt thereof are disclosed. The formulations provide therapeutic plasma levels of the antihyperglycemic drug to a human patient over a 24 hour period after administration.
Inventor(s): Cheng; Xiu Xiu (Weston, FL), Jan; Steve (Coral Spings, FL), Chou; Joseph (Manasses, VA), Chen; Chih-Ming (Taipei, TW)
Assignee: Andrx Labs, LLC (Davie, FL)
Application Number:13/052,154
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form; Device;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 2nd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXNo8,475,841► subscribe ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYes8,475,841► subscribe ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004RXYes8,475,841► subscribe METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
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Non-Orange Book Patents for Patent: 8,475,841

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
7,919,116Controlled release metformin formulations► subscribe
6,099,859 Controlled release oral tablet having a unitary core► subscribe
6,495,162 Controlled release oral tablet having a unitary core► 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: 8,475,841

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia3101999► subscribe
Australia739226► subscribe
Canada2324493► 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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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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