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Last Updated: March 19, 2024

ONGLYZA Drug Patent Profile


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Which patents cover Onglyza, and what generic alternatives are available?

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

This drug has fifty-seven patent family members in thirty-two countries.

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

DrugPatentWatch® Generic Entry Outlook for Onglyza

Onglyza was eligible for patent challenges on July 31, 2013.

There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (saxagliptin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for ONGLYZA
Drug Prices for ONGLYZA

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Drug Sales Revenue Trends for ONGLYZA

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Recent Clinical Trials for ONGLYZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ain Shams UniversityN/A
Beni-Suef UniversityPhase 4
Sabyasachi SenPhase 4

See all ONGLYZA clinical trials

Pharmacology for ONGLYZA
Paragraph IV (Patent) Challenges for ONGLYZA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ONGLYZA Tablets saxagliptin hydrochloride 2.5 mg and 5 mg 022350 8 2013-07-31

US Patents and Regulatory Information for ONGLYZA

ONGLYZA is protected by one US patents.

Patents protecting ONGLYZA

Coated tablet formulation and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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;ORAL 022350-001 Jul 31, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ONGLYZA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ONGLYZA

When does loss-of-exclusivity occur for ONGLYZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9062
Estimated Expiration: ⤷  Try a Trial

Patent: 9567
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05249467
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0510419
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 68391
Estimated Expiration: ⤷  Try a Trial

China

Patent: 88891
Estimated Expiration: ⤷  Try a Trial

Patent: 2895208
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0160880
Estimated Expiration: ⤷  Try a Trial

Patent: 0161210
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17813
Estimated Expiration: ⤷  Try a Trial

Patent: 18162
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

Patent: 78369
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0094639
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 94951
Estimated Expiration: ⤷  Try a Trial

Patent: 55399
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 29039
Estimated Expiration: ⤷  Try a Trial

Patent: 29446
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9454
Estimated Expiration: ⤷  Try a Trial

Patent: 8117
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 01727
Estimated Expiration: ⤷  Try a Trial

Patent: 08501025
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7639
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06013711
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 516
Estimated Expiration: ⤷  Try a Trial

Patent: 643
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1591
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 3907
Estimated Expiration: ⤷  Try a Trial

Patent: 065870
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060425
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 72894
Estimated Expiration: ⤷  Try a Trial

Patent: 06146971
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 929
Estimated Expiration: ⤷  Try a Trial

Patent: 174
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0609541
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1290925
Estimated Expiration: ⤷  Try a Trial

Patent: 070027560
Estimated Expiration: ⤷  Try a Trial

Patent: 120064141
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 82646
Estimated Expiration: ⤷  Try a Trial

Patent: 93582
Estimated Expiration: ⤷  Try a Trial

Patent: 54573
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 54569
Estimated Expiration: ⤷  Try a Trial

Patent: 15635
Estimated Expiration: ⤷  Try a Trial

Patent: 0609002
Estimated Expiration: ⤷  Try a Trial

Patent: 1204414
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 168
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ONGLYZA around the world.

Country Patent Number Title Estimated Expiration
Luxembourg 91650 ⤷  Try a Trial
China 102895208 Coated tablet formulation and method ⤷  Try a Trial
Croatia P20160880 ⤷  Try a Trial
Hungary 230347 Dipeptidil peptidáz IV ciklopropil-kondenzált pirrolidin-bázisú inhibitorai, eljárás az elõállításukra és alkalmazásuk (Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase iv, process for their preparation and their use) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 0168603 ⤷  Try a Trial
Japan 4901727 ⤷  Try a Trial
Taiwan 200609002 Coated tablet formulation and method ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONGLYZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2139494 C202030045 Spain ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
2498758 LUC00152 Luxembourg ⤷  Try a Trial PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1261586 SPC/GB10/001 United Kingdom ⤷  Try a Trial PRODUCT 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
1261586 10C0010 France ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE CHLORHYDRATE DE SAXAGLIPTINE; NAT. REGISTRATION NO/DATE: EU/1/09/545/001 20091001; FIRST REGISTRATION: EU/1/09/454/001 20091001
1084705 CR 2014 00062 Denmark ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1261586 SPC005/2010 Ireland ⤷  Try a Trial SPC005/2010: 20100702, EXPIRES: 20240930
1261586 C01261586/01 Switzerland ⤷  Try a Trial FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.