Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Harvard Business School
McKinsey
Medtronic
Moodys

Last Updated: November 28, 2021

DrugPatentWatch Database Preview

GEMCITABINE HYDROCHLORIDE Drug Patent Profile


Email this page to a colleague

« Back to Dashboard

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

Gemcitabine Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Am Regent, Apotex, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, and Teva Pharms. and is included in twenty-nine NDAs.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gemcitabine Hydrochloride

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

  Free Forever Trial

Drug patent expirations by year for GEMCITABINE HYDROCHLORIDE
Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of BernPhase 2
3D Medicines (Sichuan) Co., Ltd.Phase 2
Hospital Centre Biel/BiennePhase 2

See all GEMCITABINE HYDROCHLORIDE clinical trials

Pharmacology for GEMCITABINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for GEMCITABINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for GEMCITABINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
GEMZAR INJECTABLE;INJECTION gemcitabine hydrochloride 020509 2005-11-14
GEMZAR INJECTABLE;INJECTION gemcitabine hydrochloride 020509 2005-11-01

US Patents and Regulatory Information for GEMCITABINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meitheal GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 212129-003 Dec 11, 2020 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hospira GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078339-002 Jul 25, 2011 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novast Labs GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 210383-002 Feb 14, 2019 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Shilpa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 207575-001 Feb 22, 2019 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan Labs Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200145-003 Jul 25, 2011 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novast Labs GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 210383-003 Feb 14, 2019 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Moodys
Mallinckrodt
Boehringer Ingelheim
Harvard Business School

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.