Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 21, 2019

DrugPatentWatch Database Preview

SYNJARDY Drug Profile

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When do Synjardy patents expire, and when can generic versions of Synjardy launch?

Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-seven patent family members in thirty-nine countries.

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.

Drug patent expirations by year for SYNJARDY
Drug Prices for SYNJARDY

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Recent Litigation for SYNJARDY

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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

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Synonyms for SYNJARDY
Empagliflozin / metformin
Empagliflozin and metformin HCl
Empagliflozin and metformin hydrochloride
Empagliflozin mixture with metformin hydrochloride
Metformin / Empagliflozin
S900006750
Synjardy XR

US Patents and Regulatory Information for SYNJARDY

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   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 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 Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for SYNJARDY
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 5 mg/500 mg5 mg/1000 mg12.5 mg/500 mg12.5 mg/1000 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablets 5 mg/1000 mg10 mg/1000 mg12.5 mg/1000 mg25 mg/1000 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for SYNJARDY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 PA2014035 Lithuania   Start Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 C300696 Netherlands   Start Trial PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
1730131 C 2014 039 Romania   Start Trial PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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