GEMZAR Drug Patent Profile
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When do Gemzar patents expire, and what generic alternatives are available?
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.
Summary for GEMZAR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 704 |
Patent Applications: | 8,044 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Georgetown University | Phase 1 |
Gødstrup Hospital | Phase 2 |
Fudan University | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for GEMZAR
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-001 | May 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | GEMZAR | gemcitabine hydrochloride | INJECTABLE;INJECTION | 020509-002 | May 15, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
German Democratic Republic | 216468 | VERFAHREN ZUR HERSTELLUNG VON NUCLEOSIDEN | ⤷ Try a Trial |
Poland | 246601 | ⤷ Try a Trial | |
Israel | 77133 | ANTINEOPLASTIC PHARMACEUTICAL COMPOSITIONS CONTAINING PENTOFURANOSIDE DERIVATIVES,SOME NEW SUCH COMPOUNDS AND THEIR PREPARATION | ⤷ Try a Trial |
Ireland | 840584 | ⤷ Try a Trial | |
Singapore | 21889 | ⤷ Try a Trial | |
>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 | ⤷ Try a Trial | SPC/GB95/03: 20040306, EXPIRES: 20090305 |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |