Bendamustine hydrochloride - Generic Drug Details

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

Bendamustine hydrochloride is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, Cephalon, Eagle Pharms, Baxter Hlthcare Corp, Hospira, and Azurity, and is included in fifteen NDAs. There are twenty-eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bendamustine hydrochloride has one hundred and fifty-six patent family members in thirty-two countries.

There are sixteen drug master file entries for bendamustine hydrochloride. Eleven suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for bendamustine hydrochloride

International Patents:	156
US Patents:	28
Tradenames:	5
Applicants:	13
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	359
Patent Applications:	3,433
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bendamustine hydrochloride
What excipients (inactive ingredients) are in bendamustine hydrochloride?	bendamustine hydrochloride excipients list
DailyMed Link:	bendamustine hydrochloride at DailyMed

Recent Clinical Trials for bendamustine hydrochloride

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

Sponsor	Phase
Stanford University	Phase 1
Kyverna Therapeutics	Phase 1
Mayo Clinic	Phase 1

See all bendamustine hydrochloride clinical trials

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Subscribe	⤷ Subscribe	100MG/VIAL	POWDER;IV (INFUSION)
⤷ Subscribe	⤷ Subscribe	25MG/VIAL	POWDER;IV (INFUSION)
⤷ Subscribe	⤷ Subscribe	100MG/VIAL	POWDER;IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bendamustine hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride

Antineoplastic Agents, Alkylating

Anatomical Therapeutic Chemical (ATC) Classes for bendamustine hydrochloride

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BENDAMUSTINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELRAPZO	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	205580	1	2018-07-17
BENDEKA	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	208194	1	2017-05-04
TREANDA	Injection	bendamustine hydrochloride	90 mg/mL, 0.5 mL and 2 mL in single- dose vials	022249	1	2014-06-19
TREANDA	Injection	bendamustine hydrochloride	25 mg/vial and 100 mg/vial	022249	10	2013-06-04

US Patents and Regulatory Information for bendamustine hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	205376-002	Dec 7, 2022	AP	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Eugia Pharma	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	214739-001	Jun 5, 2023	AP	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Dr Reddys	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	205376-001	Dec 7, 2022	AP	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Hospira	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	211530-003	Dec 15, 2022		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Breckenridge	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	205447-002	Feb 14, 2023	AP	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes	11,103,483	⤷ Subscribe	Y			⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for bendamustine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2271315	FORMES SOLIDES D'HYDROCHLORURE DE BENDAMUSTINE (SOLID FORMS OF BENDAMUSTINE HYDROCHLORIDE)	⤷ Subscribe
Japan	2013056901	BENDAMUSTINE PHARMACEUTICAL COMPOSITION	⤷ Subscribe
European Patent Office	2528602	FORMULATIONS DE BENDAMUSTINE (FORMULATIONS OF BENDAMUSTINE)	⤷ Subscribe
Portugal	3533447		⤷ Subscribe
Denmark	3158991		⤷ Subscribe
European Patent Office	2827862		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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