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Serving leading biopharmaceutical companies globally:

US Army
Cipla
McKesson
Julphar
McKinsey
Cerilliant
Covington
Baxter
AstraZeneca
Federal Trade Commission

Generated: December 18, 2017

DrugPatentWatch Database Preview

Metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details

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What are the generic drug sources for metformin hydrochloride; saxagliptin hydrochloride and what is the scope of metformin hydrochloride; saxagliptin hydrochloride patent protection?

Metformin hydrochloride; saxagliptin hydrochloride
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; saxagliptin hydrochloride has one hundred and nineteen patent family members in thirty-nine countries and forty-one supplementary protection certificates in thirteen countries.

There are forty-eight drug master file entries for metformin hydrochloride; saxagliptin hydrochloride. One supplier is listed for this compound.

Summary for metformin hydrochloride; saxagliptin hydrochloride

Pharmacology for metformin hydrochloride; saxagliptin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-002Nov 5, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-003Nov 5, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-002Nov 5, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-002Nov 5, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-003Nov 5, 2010RXYesNo► Subscribe► SubscribeYY► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-002Nov 5, 2010RXYesYes► Subscribe► SubscribeYY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: metformin hydrochloride; saxagliptin hydrochloride

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
7,951,400Coated tablet formulation and method► Subscribe
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► 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 Ingredient: metformin hydrochloride; saxagliptin hydrochloride

Country Document Number Estimated Expiration
Poland1753406► Subscribe
Brazil0109115► Subscribe
MexicoPA06013711► Subscribe
China1698601► Subscribe
Japan2003531118► Subscribe
Hungary230347► Subscribe
Spain2582646► Subscribe
HungaryS1200030► Subscribe
Serbia55174► Subscribe
Japan2008501025► 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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Supplementary Protection Certificates for Tradename: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211/02Switzerland► SubscribePRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
9 5017-2014Slovakia► SubscribePRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
2010 00007Denmark► Subscribe
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
128Luxembourg► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
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Serving leading biopharmaceutical companies globally:

Moodys
Healthtrust
Boehringer Ingelheim
Covington
Baxter
Harvard Business School
Cerilliant
US Army
Farmers Insurance
Accenture

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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