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-seven patent family members in twenty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Treanda

Treanda was eligible for patent challenges on March 20, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 23, 2030. This may change due to patent challenges or generic licensing.

There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TREANDA

International Patents:	67
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	103
Patent Applications:	2,150
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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TREANDA

NDA:

022249

Dosage:

POWDER;IV (INFUSION)

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TREANDA

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

Sponsor	Phase
Incyte Corporation	Phase 3
Loxo Oncology, Inc.	Phase 3
University Health Network, Toronto	Phase 2

See all TREANDA clinical trials

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 three US patents.

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

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		RX	Yes	Yes			Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008		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		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
South Korea	20170096221	동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Australia	2015207940	Liquid Formulations of Bendamustine
Japan	2008526991
South Korea	20160098530	동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)