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Last Updated: April 22, 2024

Details for New Drug Application (NDA): 206843

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NDA 206843 describes DAKLINZA, which is a drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this drug. Additional details are available on the DAKLINZA profile page.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this compound. Additional details are available on the daclatasvir dihydrochloride profile page.
Summary for 206843
Applicant:Bristol-myers Squibb
Ingredient:daclatasvir dihydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206843
Generic Entry Date for 206843*:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 24, 2015TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 24, 2029Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Jun 13, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Aug 11, 2027Product Flag?YSubstance Flag?YDelist Request?

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