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Serving 500+ biopharmaceutical companies globally:

Cerilliant
US Army
Daiichi Sankyo
Merck
Novartis
Chubb
Moodys
Fish and Richardson
QuintilesIMS
US Department of Justice

Generated: June 28, 2017

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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 three 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 four patent family members in thirty-eight countries.

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

Summary for Generic Name: saxagliptin hydrochloride

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list14
Suppliers / Packagers: see list3
Bulk Api Vendors: see list28
Clinical Trials: see list2,343
Patent Applications: see list3,577
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:saxagliptin hydrochloride at DailyMed

Pharmacology for Ingredient: 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 Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXYesNoRE44186► SubscribeYY ► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYesYesRE44186► SubscribeYY ► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXYesNo► 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
Israel151372► Subscribe
Denmark2298288► Subscribe
Norway2012009► Subscribe
Luxembourg91650► Subscribe
Hong Kong1152516► 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
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
C005/2010Ireland► SubscribeSPC005/2010: 20100702, EXPIRES: 20240930
9Finland► Subscribe
2014043Lithuania► SubscribePRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
1084705/03Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Mallinckrodt
AstraZeneca
Citi
Argus Health
Cipla
Merck
Federal Trade Commission
UBS
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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