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Serving leading biopharmaceutical companies globally:

Queensland Health
Chubb
Cipla
Federal Trade Commission
Cantor Fitzgerald
US Department of Justice
Harvard Business School
Accenture
Argus Health
QuintilesIMS

Generated: December 11, 2017

DrugPatentWatch Database Preview

Saxagliptin hydrochloride - Generic Drug Details

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

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

Saxagliptin hydrochloride has one hundred and nineteen patent family members in thirty-nine countries and twenty-two supplementary protection certificates in eleven countries.

There are fifteen drug master file entries for saxagliptin hydrochloride. Three suppliers are listed for this compound.

Pharmacology for saxagliptin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,628,799Coated tablet formulation and method► Subscribe
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► Subscribe
9,339,472Coated tablet formulation 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: saxagliptin hydrochloride

Country Document Number Estimated Expiration
Spain2582646► Subscribe
Japan5951843► Subscribe
Norway2010006► Subscribe
Spain2456667► Subscribe
South Korea100758407► Subscribe
Poland365520► Subscribe
Lithuania2298288► Subscribe
Uruguay26613► Subscribe
World Intellectual Property Organization (WIPO)0168603► Subscribe
Colombia5280198► 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: SAXAGLIPTIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB14/085United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
9Finland► Subscribe
00707Netherlands► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
C/GB10/001United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
2012 00014Denmark► Subscribe
C0028France► SubscribePRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
650Luxembourg► Subscribe91650, EXPIRES: 20241001
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Queensland Health
Express Scripts
Chubb
Federal Trade Commission
Citi
Cantor Fitzgerald
Moodys
Medtronic

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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