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INLEXZO

NDA

GEMCITABINE HYDROCHLORIDE | N219683 | JANSSEN BIOTECH INC

1 strength6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Apr. 15, 2032

Aug. 19, 2034

Jun. 28, 2030

Aug. 19, 2034

Dec. 17, 2030

Nov. 7, 2038

Sep. 9, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

500 trials from ClinicalTrials.gov, 73 active, 427 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies NCT03233139	Phase 1	Active	Regeneron Pharmaceuticals	146	2017-06-21 → 2027-09-30
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread NCT04233866	Phase 2	Active	ECOG-ACRIN Cancer Research Group	176	2020-08-26 → 2026-12-31
Paediatric Hepatic International Tumour Trial NCT03017326	Phase 3	Active	University of Birmingham	450	2017-08-24 → 2027-12
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer NCT04223856	Phase 3	Active	Astellas Pharma Global Development, Inc.	886	2020-03-30 → 2028-03-01
Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma NCT02921022	N/A	Active	Memorial Sloan Kettering Cancer Center	110	2016-10 → 2026-10
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)NCT04241185	Phase 3	Active	Merck Sharp & Dohme LLC	520	2020-05-19 → 2031-11-01
Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer NCT04274426	Phase 2	Active	AGO Research GmbH	136	2021-10-13 → 2026-12
TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature NCT02641847	Phase 2/3	Active	Fudan University	503	2016-01 → 2027-12
1911GCCC: Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma NCT04098081	Phase 2	Active	University of Maryland, Baltimore	15	2019-12-12 → 2026-12-31
A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer NCT02151084	Phase 2	Active	University Health Network, Toronto	57	2014-11 → 2027-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$52666.23

Highest Price

$68998.99

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
57894-0225-01INLEXZO 225MG INTRAVESICAL SYSTEM	$68998.99	FSS	J & J Health Care Systems on behalf of Janssen Biotech Inc.	08/31/2029
57894-0225-01INLEXZO 225MG INTRAVESICAL SYSTEM	$52666.23	Big4	J & J Health Care Systems on behalf of Janssen Biotech Inc.	08/31/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain21 active DMFs12 inactive

16 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDGEMCITABINE HYDROCHLORIDE USP

DMF 188572005

SCINOPHARM TAIWAN LTDGEMCITABINE HYDROCHLORIDE USP

DMF 190532005

SUN PHARMACEUTICAL INDUSTRIES LTDGEMCITABINE HYDROCHLORIDE USP

DMF 194272006

TAPI NL BVGEMCITABINE HYDROCHLORIDE

DMF 209792007

HETERO LABS LTDGEMCITABINE HYDROCHLORIDE USP

DMF 222292008

INTAS PHARMACEUTICALS LTDGEMCITABINE HYDROCHLORIDE USP

DMF 227482009

LAURUS LABS LTDGEMCITABINE HYDROCHLORIDE USP

DMF 228002009

EMCURE PHARMACEUTICALS LTDGEMCITABINE HYDROCHLORIDE USP

DMF 233392009

ARCH PHARMALABS LTDGEMCITABINE HYDROCHLORIDE USP

DMF 236332010

ARCH PHARMALABS LTDGEMCITABINE HYDROCHLORIDE USP (CODE: GMI)

DMF 238012010

SHILPA PHARMA LIFESCIENCES LTDGEMCITABINE HYDROCHLORIDE USP

DMF 241362011

GLAND CHEMICALS PRIVATE LTDGEMCITABINE HYDROCHLORIDE USP

DMF 259382012

MSN LABORATORIES PRIVATE LTDGEMCITABINE HYDROCHLORIDE USP [ROUTE CODE - "GH"]

DMF 270432013

TAPI NL BVGEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS)

DMF 274022014

EMCURE PHARMACEUTICALS LTDGEMCITABINE HYDROCHLORIDE USP (PROCESS II)

DMF 276172013

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDGEMCITABINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 311172018

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDGEMCITABINE HYDROCHLORIDE USP

DMF 314812017

SHILPA PHARMA LIFESCIENCES LTDGEMCITABINE HYDROCHLORIDE USP (PROCESS -2)

DMF 318922017

INTAS PHARMACEUTICALS LTDGEMCITABINE HYDROCHLORIDE USP (PROCESS-III)

DMF 365732021

RAVI BIOLIFE PRIVATE LTDGEMCITABINE HYDROCHLORIDE USP

DMF 398242024

FARMHISPANIA SAGEMCITABINE HYDROCHLORIDE USP

DMF 401332024

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDInactiveGEMCITABINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 188102005

BENZOCHEM LIFESCIENCES PVT LTDInactiveGEMCITABINE HYDROCHLORIDE USP

DMF 212742008

FRESENIUS KABI ONCOLOGY LTDInactiveGEMCITABINE HYDROCHLORIDE

DMF 213992008

OLON SPAInactiveGEMCITABINE HYDROCHLORIDE

DMF 221992008

CADILA HEALTHCARE LTDInactiveGEMCITABINE HYDROCHLORIDE USP

DMF 234332010

EUTICALS SPAInactiveGEMCITABINE HYDROCHLORIDE

DMF 235162010

MYLAN LABORATORIES LTDInactiveGEMCITABINE HYDROCHLORIDE USP

DMF 238332010

PHARMAESSENTIA CORPInactiveGEMCITABINE HYDROCHLORIDE

DMF 242782010

JARI PHARMACEUTICAL CO LTDInactiveGEMCITABINE HYDROCHLORIDE

DMF 243412010

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveGEMCITABINE HYDROCHLORIDE USP

DMF 248932011

CIPLA LTDInactiveGEMCITABINE HYDROCHLORIDE USP

DMF 274422013

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveGEMCITABINE HYDROCHLORIDE

DMF 276492013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 11, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 225MG BASE

RLD

6 patents1 exclusivity▴

SYSTEM;INTRAVESICAL | Approved: Sep 9, 2025

Patents (6) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8679094	Apr 15, 2032	—	—	Yes	—	—
10729823	Aug 19, 2034	—	—	Yes	—	—
12403086	Jun 28, 2030	—	—	Yes	—	—
12447241	Aug 19, 2034	—	—	Yes	—	—
12576253	Dec 17, 2030	—	—	Yes	—	—
12636300Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Nov 7, 2038	—	—	—		—

Exclusivities (1)

Code	Date	Status
NP	Sep 9, 2028	Active