GEMCITABINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for gemcitabine hydrochloride and what is the scope of patent protection?
Gemcitabine hydrochloride
is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, Teyro Labs, and Lilly, and is included in thirty-two NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Gemcitabine hydrochloride has seventeen patent family members in fourteen countries.
There are thirty drug master file entries for gemcitabine hydrochloride. Thirteen suppliers are listed for this compound.
Summary for GEMCITABINE HYDROCHLORIDE
International Patents: | 17 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 26 |
NDAs: | 32 |
Drug Master File Entries: | 30 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 2,804 |
Patent Applications: | 8,052 |
What excipients (inactive ingredients) are in GEMCITABINE HYDROCHLORIDE? | GEMCITABINE HYDROCHLORIDE excipients list |
DailyMed Link: | GEMCITABINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Lee Ocuin, MD | Phase 2 |
Merck Sharp & Dohme LLC | Phase 2 |
Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel | Phase 2 |
Pharmacology for GEMCITABINE HYDROCHLORIDE
Drug Class | Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for GEMCITABINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GEMCITABINE HYDROCHLORIDE
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 GEMCITABINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira Inc | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 200795-003 | Aug 4, 2011 | AP | RX | Yes | Yes | ⤷ 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 | ||||
Shilpa | GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | INJECTABLE;INJECTION | 207575-002 | Feb 22, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm | INFUGEM | gemcitabine hydrochloride | SOLUTION;INTRAVENOUS | 208313-007 | Jul 16, 2018 | DISCN | Yes | No | ⤷ 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 |
Expired US Patents for GEMCITABINE HYDROCHLORIDE
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 GEMCITABINE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20150014438 | ⤷ Sign Up | |
Mexico | 2014013101 | SOLUCION DE GEMCITABINA LISTA PARA INFUNDIR. (READY TO BE INFUSED GEMCITABINE SOLUTION.) | ⤷ Sign Up |
European Patent Office | 2656848 | Solution de gemcitabine prête à être infusée (Ready to be infused gemcitabine solution) | ⤷ Sign Up |
Russian Federation | 2621144 | ЛЕКАРСТВЕННАЯ ФОРМА ГЕМЦИТАБИНА БОЛЬШОГО ОБЪЕМА ДЛЯ ИНФУЗИИ И КОМПЛЕКТ, ВКЛЮЧАЮЩИЙ ЛЕКАРСТВЕННУЮ ФОРМУ (PHARMACEUTICAL FORM OF GEMCITABINE OF LARGE VOLUME FOR INFUSION AND KIT CONTAINING FORMULATIONS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GEMCITABINE HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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