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Details for Generic Name: gemcitabine hydrochloride

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Gemcitabine hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Actavis Totowa, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, Teva Pharms, and Lilly, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for gemcitabine hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: gemcitabine hydrochloride

Tradenames:2
Patents:0
Applicants:18
NDAs:20
Drug Master File Entries: see list27
Suppliers / Packaging: see list8

Pharmacology for Ingredient: gemcitabine hydrochloride

Tentative approvals for GEMCITABINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTIONEQ 200MG BASE/VIAL
<disabled><disabled>INJECTABLE; INJECTIONEQ 1GM BASE/VIAL

Clinical Trials for: gemcitabine hydrochloride

Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas
Status: Recruiting Condition: Pancreatic Cancer

Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors or Lymphoma
Status: Recruiting Condition: Lymphoma; Solid Neoplasm

ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors
Status: Completed Condition: Adult Solid Neoplasm; BRCA1 Mutation Carrier; BRCA2 Mutation Carrier

Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Status: Recruiting Condition: BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Metastatic Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Gamma-Secretase Inhibitor RO4929097 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors
Status: Completed Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas
Status: Recruiting Condition: Lymphoma

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION091365-001Jul 25, 2011RXNo<disabled><disabled>
Gland Pharma Ltd
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION204520-002Jan 5, 2016RXNo<disabled><disabled>
Fresenius Kabi Oncol
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION090799-003May 16, 2011RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: gemcitabine hydrochloride

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 19964,808,614*PED<disabled>
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 19965,464,826*PED<disabled>
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 19964,808,614*PED<disabled>
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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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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