Gemcitabine Hydrochloride Patent Expiration

Gemcitabine Hydrochloride was first introduced by Eli Lilly And Co in its drug Gemzar on May 15, 1996. Other drugs containing Gemcitabine Hydrochloride are Inlexzo, Avgemsi, Infugem, Gemcitabine Hydrochloride. 28 different companies have introduced drugs containing Gemcitabine Hydrochloride.


Gemcitabine Hydrochloride Patents

Given below is the list of patents protecting Gemcitabine Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Inlexzo US12636300 Methods Of Treatment And Maintenance Therapy For Bladder Cancer Using Gemcitabine Nov 07, 2038 Janssen Biotech
Inlexzo US10729823 Multi-Unit Drug Delivery Devices And Methods Aug 19, 2034 Janssen Biotech
Inlexzo US12447241 Multi-Unit Drug Delivery Devices And Methods Aug 19, 2034 Janssen Biotech
Infugem US9241948 Ready to be infused gemcetabine solution Jul 01, 2033 Sun Pharm
Inlexzo US8679094 Implantable Device With Intravesical Tolerability And Methods Of Treatment Apr 15, 2032 Janssen Biotech
Inlexzo US12576253 Drug Delivery Device With Intravesical Tolerability Dec 17, 2030 Janssen Biotech
Inlexzo US12403086 Solid Drug Tablets For Implantable Drug Delivery Devices Jun 28, 2030 Janssen Biotech
Gemzar US5464826

(Pediatric)

Method of treating tumors in mammals with 2',2'-difluoronucleosides May 07, 2013

(Expired)

Lilly
Gemzar US5464826 Method of treating tumors in mammals with 2',2'-difluoronucleosides Nov 07, 2012

(Expired)

Lilly



Gemcitabine Hydrochloride's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Gemcitabine Hydrochloride:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL Hutchmed NA COMPLETED
(Sep 1, 2026)
PHASE2
Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma Tarapeutics Science Inc. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
A Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE3


Gemcitabine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Gemcitabine Hydrochloride. The first generic version for Gemcitabine Hydrochloride was by Hospira Inc and was approved on Nov 15, 2010. And the latest generic version is by Hikma Pharmaceuticals International Ltd and was approved on Mar 7, 2023.

Given below is the list of companies who have filed for Gemcitabine Hydrochloride generic, along with the locations of their manufacturing plants worldwide.