Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Medtronic
Colorcon
AstraZeneca
Express Scripts

Last Updated: September 27, 2022

ONGLYZA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-seven patent family members in forty-one countries.

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Two 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 30, 2028. This may change due to patent challenges or generic licensing.

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

< Available with Subscription >

  Try it Free

Drug patent expirations by year for ONGLYZA
Drug Prices for ONGLYZA

See drug prices for ONGLYZA

Drug Sales Revenue Trends for ONGLYZA

See drug sales revenues for ONGLYZA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ONGLYZA
Generic Entry Date for ONGLYZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ONGLYZA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting ONGLYZA

Coated tablet formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN ALONE OR IN COMBINATION WITH INSULIN, METFORMIN, A THIAZOLIDINEDIONE, GLYBURIDE OR METFORMIN PLUS A SULFONYLUREA

Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN

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 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 9567
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05249467
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0510419
Estimated Expiration: See Plans and Pricing

Canada

Patent: 68391
Estimated Expiration: See Plans and Pricing

China

Patent: 88891
Estimated Expiration: See Plans and Pricing

Patent: 2895208
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160880
Estimated Expiration: See Plans and Pricing

Patent: 0161210
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17813
Estimated Expiration: See Plans and Pricing

Patent: 18162
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

Patent: 78369
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0094639
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 94951
Estimated Expiration: See Plans and Pricing

Patent: 55399
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 29039
Estimated Expiration: See Plans and Pricing

Patent: 29446
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9454
Estimated Expiration: See Plans and Pricing

Patent: 8117
Estimated Expiration: See Plans and Pricing

Japan

Patent: 01727
Estimated Expiration: See Plans and Pricing

Patent: 08501025
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 98288
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7639
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06013711
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 516
Estimated Expiration: See Plans and Pricing

Patent: 643
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1591
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3907
Estimated Expiration: See Plans and Pricing

Patent: 065870
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060425
Estimated Expiration: See Plans and Pricing

Poland

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 72894
Estimated Expiration: See Plans and Pricing

Patent: 06146971
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 929
Estimated Expiration: See Plans and Pricing

Patent: 174
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0609541
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1290925
Estimated Expiration: See Plans and Pricing

Patent: 070027560
Estimated Expiration: See Plans and Pricing

Patent: 120064141
Estimated Expiration: See Plans and Pricing

Spain

Patent: 82646
Estimated Expiration: See Plans and Pricing

Patent: 93582
Estimated Expiration: See Plans and Pricing

Patent: 54573
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 54569
Estimated Expiration: See Plans and Pricing

Patent: 15635
Estimated Expiration: See Plans and Pricing

Patent: 0609002
Estimated Expiration: See Plans and Pricing

Patent: 1204414
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 168
Estimated Expiration: See Plans and Pricing

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 91985 See Plans and Pricing
Mexico PA06013711 FORMULACION DE TABLETA REVESTIDA Y METODO. (COATED TABLET FORMULATION AND METHOD.) See Plans and Pricing
Taiwan 200624420 See Plans and Pricing
European Patent Office 1261586 INHIBITEURS DE LA DIPEPTIDYL-PEPTIDASE IV COMPRENANT UNE PYRROLIDINE ET UN CYCLOPROPYLE FUSIONNES, PROCEDES POUR LEUR PREPARATION ET UTILISATION DE CES COMPOSES (CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF DIPEPTIDYL PEPTIDASE IV, PROCESSES FOR THEIR PREPARATION, AND THEIR USE) See Plans and Pricing
Hungary E029446 See Plans and Pricing
Denmark 1753406 See Plans and Pricing
Portugal 1753406 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONGLYZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 SZ 4/2010 Austria See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
1261586 4/2010 Austria See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
1084705 CA 2014 00062 Denmark See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
2498758 LUC00152 Luxembourg See Plans and Pricing 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 2012C/016 Belgium See Plans and Pricing PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
2139494 132020000000115 Italy See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719
2139494 2090034-6 Sweden See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 20160719
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Express Scripts
Mallinckrodt
Moodys
AstraZeneca

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.