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Bendamustine hydrochloride - Generic Drug Details

What are the generic sources for bendamustine hydrochloride and what is the scope of bendamustine hydrochloride patent protection?
Bendamustine hydrochloride is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Breckenridge Pharm, Glenmark Pharms Ltd, Hospira Inc, Innopharma Licensing, Cephalon, and Eagle Pharms, and is included in seven NDAs. There are twenty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bendamustine hydrochloride has ninety-four patent family members in thirty-one countries.

There are twenty-two drug master file entries for bendamustine hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for bendamustine hydrochloride

International Patents:	94
US Patents:	22
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	22
Suppliers / Packagers:	2
Bulk Api Vendors:	73
Clinical Trials:	255
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	bendamustine hydrochloride at DailyMed

Pharmacology for bendamustine hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride

Antineoplastic Agents, Alkylating

Tentative approvals for BENDAMUSTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	100MG	INJECTABLE; INJECTION

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)	022249-002	May 1, 2009	AP	RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes	➤ Sign Up	➤ Sign Up			Y	➤ Sign Up
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Non-Orange Book US Patents for bendamustine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
8,461,350	Bendamustine pharmaceutical compositions	➤ Sign Up
9,572,888	Formulations of bendamustine	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for bendamustine hydrochloride

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Country	Document Number	Estimated Expiration
China	104224703	➤ Sign Up
China	101980698	➤ Sign Up
China	104271135	➤ Sign Up
Lithuania	2528602	➤ Sign Up
Country	Document Number	Estimated Expiration