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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Infugem
A generic version of INFUGEM was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15th, 2010.
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 |


Recent Clinical Trials for INFUGEM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Alkermes, Inc. | Phase 3 |
Merck Sharp & Dohme Corp. | Phase 3 |
Stanford University | Phase 2 |
Pharmacology for INFUGEM
Drug Class | Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |