You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 15, 2024

Metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Metformin hydrochloride; saxagliptin hydrochloride is the generic ingredient in three branded drugs marketed by Astrazeneca Ab, Dr Reddys Labs Sa, Mylan, and Sun Pharm, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; saxagliptin hydrochloride has fifty-seven patent family members in thirty-two countries.

Three suppliers are listed for this compound.

Summary for metformin hydrochloride; saxagliptin hydrochloride
International Patents:57
US Patents:2
Tradenames:3
Applicants:4
NDAs:4
Finished Product Suppliers / Packagers: 3
Clinical Trials: 60
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for metformin hydrochloride; saxagliptin hydrochloride
DailyMed Link:metformin hydrochloride; saxagliptin hydrochloride at DailyMed
Recent Clinical Trials for metformin hydrochloride; saxagliptin hydrochloride

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

SponsorPhase
Sabyasachi SenPhase 4
Zhujiang HospitalPhase 4
First People's Hospital, Shunde ChinaPhase 4

See all metformin hydrochloride; saxagliptin hydrochloride clinical trials

Pharmacology for metformin hydrochloride; saxagliptin hydrochloride
Drug ClassBiguanide
Dipeptidyl Peptidase 4 Inhibitor
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for metformin hydrochloride; saxagliptin hydrochloride
A10BA Biguanides
A10B BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10 DRUGS USED IN DIABETES
A Alimentary tract and metabolism
A10BH Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10 DRUGS USED IN DIABETES
A Alimentary tract and metabolism
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KOMBIGLYZE XR Extended-release Tablets metformin hydrochloride; saxagliptin hydrochloride 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg 200678 3 2013-07-31

US Patents and Regulatory Information for metformin hydrochloride; saxagliptin hydrochloride

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 206081-002 Jul 31, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 207678-002 Aug 9, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205981-003 Jul 31, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 206081-003 Jul 31, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 207678-001 Aug 9, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Subscribe to access the full database, or Sign Up

Expired US Patents for metformin hydrochloride; saxagliptin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Subscribe to access the full database, or Sign Up

International Patents for metformin hydrochloride; saxagliptin hydrochloride

Country Patent Number Title Estimated Expiration
Israel 179454 COATED TABLET FORMULATION COMPRISING SAXAGLIPTIN AND METHOD FOR PREPARING THE SAME ⤷  Sign Up
South Korea 20070027560 COATED TABLET FORMULATION AND METHOD ⤷  Sign Up
South Korea 20120064141 COATED TABLET FORMULATION AND METHOD ⤷  Sign Up
Norway 20065870 ⤷  Sign Up
Taiwan I415635 ⤷  Sign Up
Lithuania 2298288 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Subscribe to access the full database, or Sign Up

Supplementary Protection Certificates for metformin hydrochloride; saxagliptin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498758 LUC00152 Luxembourg ⤷  Sign Up 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
2498758 132020000000034 Italy ⤷  Sign Up PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
2498758 122020000018 Germany ⤷  Sign Up PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211 C300677 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
2498758 2090013-0 Sweden ⤷  Sign Up PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
1412357 C 2008 016 Romania ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Subscribe to access the full database, or Sign Up

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

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.

 
© Copyright 2002-2024 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
 NCE-1 Patent Challenge Dates 2024 - 2025
 Trigger-based marketing for the life sciences
 Get DrugPatentWatch Business Intelligence Reports at Amazon.com
 DrugChatter - AI-based answers to questions about drugs
 RxJam - Digital Marketing for Life Sciences
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links

Follow DrugPatentWatch:

  DrugPatentWatch Linkedin Group