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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
McKesson
Queensland Health
Farmers Insurance
Dow
Baxter
McKinsey
Express Scripts
US Army

Generated: December 18, 2018

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INFUGEM Drug Profile

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

Infugem is a drug marketed by Sun Pharm Inds Ltd and is included in one NDA. There is one patent protecting this drug.

This drug has seventeen patent family members in fourteen countries.

The generic ingredient in INFUGEM is gemcitabine hydrochloride. There are twenty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Summary for INFUGEM
International Patents:17
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Formulation / Manufacturing:see details
DailyMed Link:INFUGEM at DailyMed
Drug patent expirations by year for INFUGEM

US Patents and Regulatory Information for INFUGEM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-001 Jul 16, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Ltd INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-007 Jul 16, 2018 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Inds Ltd INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-004 Jul 16, 2018 RX Yes Yes ➤ 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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Supplementary Protection Certificates for INFUGEM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB95/031 United Kingdom ➤ Sign Up PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026
C0030 Belgium ➤ Sign Up PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
McKesson
Queensland Health
Farmers Insurance
Dow
Baxter
McKinsey
Express Scripts
US Army

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