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. Fourteen 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 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 2 |
| Patent Applications: | 8,044 |
| 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 |
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-007 | Jul 16, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-004 | Jul 16, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-008 | Jul 16, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-002 | Jul 16, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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
See the table below for patents covering INFUGEM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2014147388 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2013171763 | ⤷ Try a Trial | |
| Australia | 2013261012 | ⤷ Try a Trial | |
| South Korea | 101716215 | ⤷ Try a Trial | |
| Spain | 2537294 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INFUGEM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0122707 | 96C0030 | Belgium | ⤷ Try a 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 |
| 0122707 | SPC/GB95/031 | United Kingdom | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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