Last Updated: June 22, 2026

GEMCITABINE Drug Patent Profile

Name: GEMCITABINE Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

✉ Email this page to a colleague

« Back to Dashboard

When do Gemcitabine patents expire, and when can generic versions of Gemcitabine launch?

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, Hameln Rds Gmbh, Hikma, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Novast Labs, Pharmobedient, 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.

Start Trial

AI Deep Research

Questions you can ask:

What is the 5 year forecast for GEMCITABINE?
What are the global sales for GEMCITABINE?
What is Average Wholesale Price for GEMCITABINE?

Summary for GEMCITABINE

US Patents:	0
Applicants:	25
NDAs:	30
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

US Patents and Regulatory Information for GEMCITABINE

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Meitheal	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	212129-002	Dec 11, 2020	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma Intl Pharms	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	206617-001	Jun 25, 2021		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Novast Labs	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	210383-001	Feb 14, 2019		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

DrugChatter Q&A for GEMCITABINE

Gemcitabine fda orange book exclusivity?
How long can gemcitabine be out of the fridge?

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.