BENDAMUSTINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for bendamustine hydrochloride and what is the scope of freedom to operate?

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:	3,124
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
Kyverna Therapeutics	Phase 1
Stanford University	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
⤷ Sign Up	⤷ Sign Up	100MG/VIAL	POWDER;IV (INFUSION)
⤷ Sign Up	⤷ Sign Up	25MG/VIAL	POWDER;IV (INFUSION)
⤷ Sign Up	⤷ Sign Up	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
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Apotex	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;IV (INFUSION)	204230-002	Jun 5, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-004	Sep 13, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Norvium Bioscience	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;IV (INFUSION)	204104-001	Apr 28, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-003	Sep 13, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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
Japan	5795600		⤷ Sign Up
Japan	5536753		⤷ Sign Up
Hong Kong	1243346	在要求減少施用容量的患者中治療苯達莫司汀響應性狀況的方法 (METHOD OF TREATING BENDAMUSTINE-RESPONSIVE CONDITIONS IN PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION)	⤷ Sign Up
Japan	6224064		⤷ Sign Up
South Korea	20070094848	BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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