Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Healthtrust
Colorcon
Fish and Richardson
Fuji
McKesson
Baxter
Boehringer Ingelheim
Novartis

Generated: December 11, 2017

DrugPatentWatch Database Preview

ONGLYZA Drug Profile

« Back to Dashboard

When do Onglyza patents expire, and what generic alternatives are available?

Onglyza is a drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.

US Patents and Regulatory Information

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► SubscribeYY► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbONGLYZAsaxagliptin hydrochlorideTABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges for ONGLYZA

Drugname Dosage Strength RLD Submissiondate
saxagliptin hydrochlorideTablets2.5 mg and 5 mgOnglyza7/31/2013

Non-Orange Book Patents for Tradename: ONGLYZA

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: ONGLYZA

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ONGLYZA

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Citi
Cipla
McKesson
Covington
Colorcon
Chinese Patent Office
Express Scripts
US Department of Justice
Mallinckrodt

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot