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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Daiichi Sankyo
Citi
Queensland Health
AstraZeneca
Chubb
Chinese Patent Office
Johnson and Johnson
Medtronic

Generated: June 19, 2018

DrugPatentWatch Database Preview

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. It is available from one supplier. 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 three drug master file entries for this compound. One supplier is listed 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
Suppliers and Packaging for NDA: 206843
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843 NDA E.R. Squibb & Sons, L.L.C. 0003-0011 N 0003-0011-01
DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843 NDA E.R. Squibb & Sons, L.L.C. 0003-0213 N 0003-0213-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Jul 24, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 5, 2019
Regulatory Exclusivity Use:DOSAGE RECOMMENDATIONS ADDED TO INCLUDE TREATMENT OF HCV GENOTYPE 3 SUBJECTS CO-INFECTED WITH HIV-1
Regulatory Exclusivity Expiration:Feb 5, 2019
Regulatory Exclusivity Use:DOSING TO INCLUDE PATIENTS WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH COMPENSATED (CHILD-PUGH A) OR DECOMPENSATED (CHILD-PUGH B OR C) CIRRHOSIS AND TREATMENT OF CHRONIC HCV GENOTYPE 3 INFECTION IN SUBJECTS WITH DECOMPENSATED (CHILD-PUGH B OR C) CIRRHOSIS
Regulatory Exclusivity Expiration:Feb 5, 2019
Regulatory Exclusivity Use:EXPANSION OF THE INDICATION TO INCLUDE TREATMENT OF SUBJECTS WITH GENOTYPE-1 CHRONIC HEPATITIS C VIRUS INFECTION, INCLUDING SUBJECTS WHO ARE CO-INFECTED WITH THE HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) BASED ON THE RESULTS FROM THE ALLY-2 CLINICAL TRIAL

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Serving hundreds of leading biopharmaceutical companies globally:

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