DrugPatentWatch Database Preview
INFUGEM Drug Profile
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 |
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 |
International Patents for INFUGEM
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Slovenia | 2656848 | ➤ Sign Up |
| South Africa | 201408502 | ➤ Sign Up |
| Japan | 2013231029 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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 |
