➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Medtronic

Last Updated: August 3, 2021

DrugPatentWatch Database Preview

GEMCITABINE HYDROCHLORIDE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic sources for gemcitabine hydrochloride and what is the scope of patent protection?

Gemcitabine hydrochloride is the generic ingredient in three branded drugs 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, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, Teva Pharms, and Lilly, and is included in thirty NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Gemcitabine hydrochloride has seventeen patent family members in fourteen countries.

There are thirty drug master file entries for gemcitabine hydrochloride. Thirteen suppliers are listed for this compound.

Summary for GEMCITABINE HYDROCHLORIDE
International Patents:17
US Patents:1
Tradenames:3
Applicants:23
NDAs:30
Drug Master File Entries: 30
Finished Product Suppliers / Packagers: 13
Raw Ingredient (Bulk) Api Vendors: 95
Clinical Trials: 2,400
Patent Applications: 7,663
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in GEMCITABINE HYDROCHLORIDE?GEMCITABINE HYDROCHLORIDE excipients list
DailyMed Link:GEMCITABINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for GEMCITABINE HYDROCHLORIDE

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

SponsorPhase
3D Medicines (Sichuan) Co., Ltd.Phase 2
William TerryEarly Phase 1
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyPhase 2

See all GEMCITABINE HYDROCHLORIDE clinical trials

Pharmacology 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
Hospira GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078339-001 Jul 25, 2011 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gland Pharma Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 204520-002 Jan 5, 2016 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Shilpa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 207575-002 Feb 22, 2019 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fresenius Kabi Usa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090799-002 Jul 25, 2011 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys Labs Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 202997-001 May 7, 2013 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys Labs Ltd GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 091365-002 Jul 25, 2011 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GEMCITABINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ⤷  Try it Free ⤷  Try it Free
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ⤷  Try it Free ⤷  Try it Free
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ⤷  Try it Free ⤷  Try it Free
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GEMCITABINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0122707 SPC/GB95/031 United Kingdom ⤷  Try it Free PRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026
0122707 96C0030 Belgium ⤷  Try it Free PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Medtronic

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.