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Profile for Tradename: GEMZAR

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Gemzar is a drug marketed by Lilly and is included in one NDA. It is available from one supplier.

The generic ingredient in GEMZAR is gemcitabine hydrochloride. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Summary for Tradename: GEMZAR

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: GEMZAR

Clinical Trials for: GEMZAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 1996RXYes<disabled><disabled>
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 1996RXYes<disabled><disabled>
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Expired Patents for Tradename: GEMZAR

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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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Paragraph IV activity for: GEMZAR

Drugname Dosage Strength RLD Submissiondate
gemcitabineFor Injection2 g/vialGemzar8/24/2007
gemcitabineFor Injection1g/vialGemzar11/14/2005
gemcitabineFor Injection200 mg/vialGemzar11/1/2005
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
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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