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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Army
Express Scripts
Boehringer Ingelheim
Farmers Insurance
Federal Trade Commission
Healthtrust
Cantor Fitzgerald
Queensland Health

Generated: December 17, 2018

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SYNJARDY Drug Profile

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Which patents cover Synjardy, and what generic alternatives are available?

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 eight patent family members in thirty-four countries.

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are twenty-one 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.

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-002 Dec 9, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim SYNJARDY XR empagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658-004 Dec 9, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
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 ➤ Try a Free Trial
➤ Subscribe Tablets 5 mg/500 mg5 mg/1000 mg12.5 mg/500 mg12.5 mg/1000 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for SYNJARDY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014035,C1730131 Lithuania ➤ Try a Free Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
14/055 Ireland ➤ Try a Free 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
90061-7 Sweden ➤ Try a Free Trial PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 20140522
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Army
Express Scripts
Boehringer Ingelheim
Farmers Insurance
Federal Trade Commission
Healthtrust
Cantor Fitzgerald
Queensland Health

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