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Last Updated: April 23, 2024

GEMCITABINE Drug Patent Profile

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Which patents cover Gemcitabine, and what generic alternatives are available?

Gemcitabine is a drug 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, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, and Teyro Labs. and is included in thirty NDAs.

The generic ingredient in GEMCITABINE 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 Gemcitabine

A generic version of GEMCITABINE was approved as gemcitabine hydrochloride by HOSPIRA INC on November 15^th, 2010.

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Summary for GEMCITABINE

US Patents:	0
Applicants:	24
NDAs:	30
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GEMCITABINE
What excipients (inactive ingredients) are in GEMCITABINE?	GEMCITABINE excipients list
DailyMed Link:	GEMCITABINE at DailyMed

Drug patent expirations by year for GEMCITABINE

Drug Prices for GEMCITABINE

US Patents and Regulatory Information for GEMCITABINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	209604-001	Aug 3, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Meitheal	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	212129-002	Dec 11, 2020	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Intl Pharms	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	206617-001	Jun 25, 2021	AP	RX	No	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

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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.