You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Empagliflozin; metformin hydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Zydus Pharms, and is included in three NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Empagliflozin; metformin hydrochloride has two hundred and forty-nine patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Recent Clinical Trials for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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

SponsorPhase
Tanta UniversityPhase 3
Handok Inc.Phase 3
Karolinska University HospitalN/A

See all EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYNJARDY Tablets empagliflozin; metformin hydrochloride 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg 206111 4 2018-08-01
SYNJARDY XR Extended-release Tablets empagliflozin; metformin hydrochloride 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg 208658 3 2018-08-01

US Patents and Regulatory Information for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX 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 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
European Patent Office 1828216 DERIVES DE BENZENE SUBSTITUES PAR GLUCOPYRANOSYLE, MEDICAMENTS CONTENANT CES COMPOSES, LEUR UTILISATION ET LEUR PROCEDE DE FABRICATION (GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVES, MEDICAMENTS CONTAINING SUCH COMPOUNDS, THEIR USE AND PROCESS FOR THEIR MANUFACTURE) ⤷  Try a Trial
European Patent Office 2981271 USAGES THÉRAPEUTIQUES D'EMPAGLIFLOZINE (THERAPEUTIC USES OF EMPAGLIFLOZIN) ⤷  Try a Trial
New Zealand 711661 Therapeutic uses of empagliflozin ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/01 Switzerland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131 C01730131/03 Switzerland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1730131 2014/055 Ireland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.