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BELEODAQ Drug Patent Profile

When do Beleodaq patents expire, and when can generic versions of Beleodaq launch?

Beleodaq is a drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in twenty-seven countries.

The generic ingredient in BELEODAQ is belinostat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the belinostat profile page.

DrugPatentWatch^® Generic Entry Outlook for Beleodaq

Beleodaq was eligible for patent challenges on July 3, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 27, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 BELEODAQ

International Patents:	59
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	16
Patent Applications:	1,831
Drug Prices:	Drug price information for BELEODAQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BELEODAQ
What excipients (inactive ingredients) are in BELEODAQ?	BELEODAQ excipients list
DailyMed Link:	BELEODAQ at DailyMed

See drug prices for BELEODAQ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BELEODAQ

NDA:

206256

Dosage:

POWDER;INTRAVENOUS

^*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 BELEODAQ

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

Sponsor	Phase
University of Utah	Phase 1
Mayo Clinic	Phase 1
Axis Clinicals Limited	Phase 1

See all BELEODAQ clinical trials

Pharmacology for BELEODAQ

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BELEODAQ

L01XH	Histone deacetylase (HDAC) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BELEODAQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELEODAQ	Injection	belinostat	500 mg/vial	206256	1	2018-07-03

US Patents and Regulatory Information for BELEODAQ

BELEODAQ is protected by two 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 BELEODAQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes			Y	Y
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes			Y

International Patents for BELEODAQ

When does loss-of-exclusivity occur for BELEODAQ?

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

Australia

Austria

Brazil

Canada

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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 BELEODAQ around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2292593
South Korea	20080016636	PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS
Eurasian Patent Organization	023400	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ (PHARMACEUTICAL FORMULATIONS COMPRISING HISTONE DEACETYLASE INHIBITORS)
Norway	339954
China	101189003	Pharmaceutical formulations of HDAC inhibitors
South Korea	101340824