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Last Updated: November 13, 2019

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Empagliflozin; metformin hydrochloride - Generic Drug Details

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

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

Empagliflozin; metformin hydrochloride has one hundred and fifty-seven patent family members in forty countries.

There are twenty-two drug master file entries for empagliflozin; metformin hydrochloride. One supplier is listed for this compound.

Recent Clinical Trials for empagliflozin; metformin hydrochloride

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

SponsorPhase
Universidad de GuanajuatoPhase 3
Hospital Regional de Alta Especialidad del BajioPhase 3
MedImmune LLCPhase 2

See all empagliflozin; metformin hydrochloride clinical trials

Recent Litigation for empagliflozin; metformin hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited2019-08-28
Boehringer Ingelheim Pharmaceuticals Inc. v. Cadila Healthcare Limited2019-07-11
Boehringer Ingelheim Pharmaceuticals Inc. v. Sun Pharmaceutical Industries Limited2018-11-08

See all empagliflozin; metformin hydrochloride litigation

Pharmacology for empagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
SYNJARDY TABLET;ORAL empagliflozin; metformin hydrochloride 206111 2018-08-01
SYNJARDY XR TABLET, EXTENDED RELEASE;ORAL empagliflozin; metformin hydrochloride 208658 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 empagliflozin; metformin hydrochloride TABLET;ORAL 206111-002 Aug 26, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-001 Aug 26, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-003 Dec 9, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for empagliflozin; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 2014/055 Ireland   Start 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
1730131 122014000099 Germany   Start Trial PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 200 5026-2014 Slovakia   Start Trial PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131 PA2014035,C1730131 Lithuania   Start Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Harvard Business School
Johnson and Johnson
Express Scripts
AstraZeneca

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