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BENDAMUSTINE HYDROCHLORIDE

NDA

BENDAMUSTINE HYDROCHLORIDE | N219014 | AVYXA HOLDINGS LLC

1 strength0 unique patents0 unique exclusivities

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
EAGLE PHARMACEUTICALS, INC. v. DR. REDDY'S LABORATORIES, LTD. et al 2:2024cv00637 2 patentsbendamustine hydrochloride	D.N.J.	2024-02-02	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

261 trials from ClinicalTrials.gov — 3 recruiting, 18 active, 170 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma NCT03269669	Phase 2	Active	National Cancer Institute (NCI)	73	2018-01-23 → 2027-01-21
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL NCT02972840	Phase 3	Active	Acerta Pharma BV	635	2017-04-05 → 2027-02-15
Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)NCT04268706	Phase 2	Active	Tessa Therapeutics	97	2021-02-01 → 2037-03
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia NCT01059786	Phase 2	Active	National Cancer Institute (NCI)	69	2010-07-01 → 2027-12-31
A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL NCT03336333	Phase 3	Active	BeiGene	590	2017-10-31 → 2027-10-31
Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia NCT01886872	Phase 3	Active	National Cancer Institute (NCI)	547	2014-01-15 → 2026-06-07
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL NCT02970318	Phase 3	Active	Acerta Pharma BV	310	2017-02-02 → 2027-10-01
Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma NCT01415752	Phase 2	Active	Eastern Cooperative Oncology Group	373	2012-08-09 → 2031-09
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma NCT04115631	Phase 2	Active	ECOG-ACRIN Cancer Research Group	360	2019-12-13 → 2026-12-31
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 NCT03755804	Phase 2	Active	St. Jude Children's Research Hospital	232	2018-12-12 → 2028-07-01

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

API Supply Chain14 active DMFs3 inactive

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

CHEMPACIFIC CORPBENDAMUSTINE HYDROCHLORIDE

DMF 226262009

DR REDDYS LABORATORIES LTDBENDAMUSTINE HYDROCHLORIDE USP

DMF 248232011

HERAEUS PRECIOUS METALS GMBH AND CO KGBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE

DMF 255122011

HETERO LABS LTDBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE USP

DMF 258002012

EMCURE PHARMACEUTICALS LTDBENDAMUSTINE HYDROCHLORIDE USP

DMF 258072012

NERPHARMA SRLBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE DRUG SUBSTANCE

DMF 261422012

NATCO PHARMA LTDBENDAMUSTINE HYDROCHLORIDE

DMF 267042012

LABORCHEMIE APOLDA GMBHBENDAMUSTINE HYDROCHLORIDE

DMF 267212014

SUN PHARMACEUTICAL INDUSTRIES LTDBENDAMUSTINE HYDROCHLORIDE

DMF 267232013

MSN LABORATORIES PRIVATE LTDBENDAMUSTINE HYDROCHLORIDE USP [ROUTE CODE - "BH"]

DMF 272052013

NAVINTA LLCBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE

DMF 272722013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDBENDAMUSTINE HYDROCHLORIDE MONOHYDRATE

DMF 274832013

FUXIN LONG RUI PHARMACEUTICAL CO LTDBENDAMUSTINE HYDROCHLORIDE

DMF 333802018

INTAS PHARMACEUTICALS LTDBENDAMUSTINE HYDROCHLORIDE

DMF 386852023

EUTICALS SPAInactiveBENDAMUSTINE HYDROCHLORIDE HYDRATE

DMF 253942011

FRESENIUS KABI ONCOLOGY LTDInactiveBENDAMUSTINE HYDROCHLORIDE

DMF 266562012

ITF CHEMICAL LTDAInactiveBENDAMUSTINE HYDROCHLORIDE

DMF 284182014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 8, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/4ML (25MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 3, 2025

No patent or exclusivity listings for this strength.