GEMZAR Drug Patent Profile
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When do Gemzar patents expire, and when can generic versions of Gemzar launch?
Gemzar is a drug marketed by Lilly and is included in one NDA.
The generic ingredient in GEMZAR is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gemzar
A generic version of GEMZAR was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15th, 2010.
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Summary for GEMZAR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 710 |
| Patent Applications: | 8,044 |
| Drug Prices: | Drug price information for GEMZAR |
| What excipients (inactive ingredients) are in GEMZAR? | GEMZAR excipients list |
| DailyMed Link: | GEMZAR at DailyMed |
Recent Clinical Trials for GEMZAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | Phase 2 |
| Shantou Central Hospital | Phase 2 |
| Merck Sharp & Dohme LLC | Phase 2 |
Paragraph IV (Patent) Challenges for GEMZAR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GEMZAR | For Injection | gemcitabine hydrochloride | 1g/vial | 020509 | 1 | 2005-11-14 |
| GEMZAR | For Injection | gemcitabine hydrochloride | 200 mg/vial | 020509 | 1 | 2005-11-01 |
US Patents and Regulatory Information for GEMZAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for GEMZAR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GEMZAR
See the table below for patents covering GEMZAR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Ireland | 57071 | IMPROVEMENTS IN OR RELATING TO NOVEL DIFLUORO ANTIVIRAL AGENTS | ⤷ Sign Up |
| China | 85109409 | ⤷ Sign Up | |
| Poland | 246601 | ⤷ Sign Up | |
| South Korea | 840007883 | ⤷ Sign Up | |
| Spain | 8602840 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GEMZAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0122707 | SPC/GB95/03 | United Kingdom | ⤷ Sign Up | SPC/GB95/03: 20040306, EXPIRES: 20090305 |
| 0122707 | SPC/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 |
| 0122707 | 96C0030 | 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 |
| >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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