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Last Updated: August 8, 2022

INFUGEM Drug Patent 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 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 thirty drug master file entries for this compound. Twelve 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
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
Formulation / Manufacturing:see details
Drug Prices: Drug price information for INFUGEM
What excipients (inactive ingredients) are in INFUGEM?INFUGEM excipients list
DailyMed Link:INFUGEM at DailyMed
Drug patent expirations by year for INFUGEM
Drug Prices for INFUGEM

See drug prices for INFUGEM

Recent Clinical Trials for INFUGEM

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

SponsorPhase
Alkermes, Inc.Phase 3
Merck Sharp & Dohme Corp.Phase 3
Stanford UniversityPhase 2

See all INFUGEM clinical trials

Pharmacology for INFUGEM

US Patents and Regulatory Information for INFUGEM

INFUGEM is protected by one US patents.

Patents protecting INFUGEM

Ready to be infused gemcetabine solution
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-001 Jul 16, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-007 Jul 16, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-004 Jul 16, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-008 Jul 16, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-002 Jul 16, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313-003 Jul 16, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for INFUGEM

See the table below for patents covering INFUGEM around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2014147388 See Plans and Pricing
South Africa 201408502 READY TO BE INFUSED GEMCITABINE SOLUTION See Plans and Pricing
European Patent Office 2656848 Solution de gemcitabine prête à être infusée (Ready to be infused gemcitabine solution) See Plans and Pricing
Japan 6159567 See Plans and Pricing
South Korea 101716215 See Plans and Pricing
Spain 2537294 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INFUGEM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0122707 SPC/GB95/031 United Kingdom See Plans and Pricing PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026
0122707 96C0030 Belgium See Plans and Pricing PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Dow
Merck
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Mallinckrodt

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