Details for New Drug Application (NDA): 206256

NDA 206256 describes BELEODAQ, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BELEODAQ profile page.

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.

Summary for 206256

Tradename:	BELEODAQ
Applicant:	Acrotech Biopharma
Ingredient:	belinostat
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206256

Constraining patent/regulatory exclusivity:

8,835,501

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.

Pharmacology for NDA: 206256

Mechanism of Action

Histone Deacetylase Inhibitors

Suppliers and Packaging for NDA: 206256

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256	NDA	Acrotech Biopharma Inc	72893-002	72893-002-01	1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL
Approval Date:	Jul 3, 2014	TE:		RLD:	Yes
Patent:	6,888,027	Patent Expiration:	Aug 10, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA (PTCL).
Patent:	8,835,501	Patent Expiration:	Oct 27, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

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