Belinostat - Generic Drug Details

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What are the generic sources for belinostat and what is the scope of patent protection?

Belinostat is the generic ingredient in one branded drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are five drug master file entries for belinostat.

Summary for belinostat

International Patents:	59
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	53
Patent Applications:	6,773
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for belinostat
What excipients (inactive ingredients) are in belinostat?	belinostat excipients list
DailyMed Link:	belinostat at DailyMed

Recent Clinical Trials for belinostat

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

Sponsor	Phase
Pfizer	Phase 2
Acrotech Biopharma	Phase 2
H. Lee Moffitt Cancer Center and Research Institute	Phase 2

See all belinostat clinical trials

Pharmacology for belinostat

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

Paragraph IV (Patent) Challenges for BELINOSTAT

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 belinostat

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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
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
>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 belinostat

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Country	Patent Number	Title	Estimated Expiration
Denmark	1901729		See Plans and Pricing
South Korea	101340824		See Plans and Pricing
Cyprus	1112498		See Plans and Pricing
South Korea	20130079665	PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS	See Plans and Pricing
Australia	9013101		See Plans and Pricing
South Korea	101329437		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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