GEMCITABINE Drug Patent Profile

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. Sixteen 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.

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

See drug prices for GEMCITABINE

US Patents and Regulatory Information for GEMCITABINE

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
Meitheal	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	212129-002	Dec 11, 2020	AP	RX	No	No
Hikma Intl Pharms	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	206617-001	Jun 25, 2021		DISCN	No	No
Novast Labs	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	210383-001	Feb 14, 2019	AP	RX	No	No
Shilpa	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	210991-003	Oct 4, 2019	AP	RX	No	No
Mylan Labs Ltd	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	205242-003	Dec 6, 2017	AP	RX	No	No