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INFUGEM Drug Profile
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» See Plans and PricingWhen 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. Seventeen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
US ANDA 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 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | INFUGEM at DailyMed |
Pharmacology for INFUGEM
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
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 | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-001 | Jul 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-007 | Jul 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-004 | Jul 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-008 | Jul 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-002 | Jul 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-003 | Jul 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-006 | Jul 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2871061 | Start Trial |
| Mexico | 2014013101 | Start Trial |
| South Korea | 20150014438 | Start Trial |
| Russian Federation | 2014147388 | Start Trial |
| Russian Federation | 2621144 | Start Trial |
| European Patent Office | 2656848 | Start Trial |
| Japan | 2013231029 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for INFUGEM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0122707 | SPC/GB95/031 | United Kingdom | Start Trial | 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 | Start Trial | 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 |
