Details for New Drug Application (NDA): 206843

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

Tradename:	DAKLINZA
Applicant:	Bristol-myers Squibb
Ingredient:	daclatasvir dihydrochloride
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206843

Dosage:

TABLET;ORAL

^*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:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 30MG BASE
Approval Date:	Jul 24, 2015	TE:		RLD:	Yes
Patent:		Patent Expiration:	Jul 24, 2029	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Jun 13, 2031	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF INHIBITING HEPATITIS C VIRUS
Patent:		Patent Expiration:	Aug 11, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF INHIBITING HEPATITIS C VIRUS

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