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Last Updated: May 25, 2024

Details for New Drug Application (NDA): 206256

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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
Applicant:Acrotech Biopharma
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206256
Generic Entry Date for 206256*:
Constraining patent/regulatory exclusivity:

*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 ActionHistone 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:RXDosage:POWDER;INTRAVENOUSStrength500MG/VIAL
Approval Date:Jul 3, 2014TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Aug 10, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 27, 2027Product Flag?YSubstance Flag?Delist Request?

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