TREANDA Drug Patent Profile

Which patents cover Treanda, and when can generic versions of Treanda launch?

Treanda is a drug marketed by Cephalon and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-six patent family members in twenty-one countries.

The generic ingredient in TREANDA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Treanda

A generic version of TREANDA was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7^th, 2022.

Summary for TREANDA

International Patents:	66
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	106
Patent Applications:	5,191
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TREANDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREANDA
What excipients (inactive ingredients) are in TREANDA?	TREANDA excipients list
DailyMed Link:	TREANDA at DailyMed

See drug prices for TREANDA

Recent Clinical Trials for TREANDA

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 1/Phase 2
Epizyme, Inc.	Phase 1/Phase 2
Vaishalee Kenkre	Phase 1/Phase 2

See all TREANDA clinical trials

Pharmacology for TREANDA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for TREANDA

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

Paragraph IV (Patent) Challenges for TREANDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 TREANDA

TREANDA is protected by two US patents.

Patents protecting TREANDA

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					Y
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-003	Sep 13, 2013		DISCN	Yes	No					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-004	Sep 13, 2013		DISCN	Yes	No					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y

International Patents for TREANDA

When does loss-of-exclusivity occur for TREANDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TREANDA around the world.

Country	Patent Number	Title	Estimated Expiration
China	103550159	Novel solid forms of bendamustine hydrochloride
World Intellectual Property Organization (WIPO)	2009120386
Japan	2013056902	BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS
Australia	2009296734	Liquid formulations of bendamustine
South Korea	20170096221	동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Japan	5536753
Singapore	158870	BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION