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Generated: March 21, 2019

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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 four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and ten patent family members in thirty-five 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
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-001 Dec 9, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-002 Aug 26, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for SYNJARDY
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 5 mg/1000 mg10 mg/1000 mg12.5 mg/1000 mg25 mg/1000 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 5 mg/500 mg5 mg/1000 mg12.5 mg/500 mg12.5 mg/1000 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for SYNJARDY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 CA 2014 00054 Denmark ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131 14C0074 France ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131 2014/055 Ireland ➤ Sign Up 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 1490061-7 Sweden ➤ Sign Up PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
1730131 PA2014035,C1730131 Lithuania ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 122014000099 Germany ➤ Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 PA2014035 Lithuania ➤ Sign Up 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 hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
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Daiichi Sankyo
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