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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Accenture
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Chinese Patent Office
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Generated: September 19, 2017

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 two 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 NDA: 206843

Tradename:
1
Applicant:
1
Ingredient:
1
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 0003-0011-01 28 TABLET in 1 BOTTLE (0003-0011-01)
DAKLINZA
daclatasvir dihydrochloride
TABLET;ORAL 206843 NDA E.R. Squibb & Sons, L.L.C. 0003-0213 0003-0213-01 28 TABLET in 1 BOTTLE (0003-0213-01)

Summary 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 500+ biopharmaceutical companies globally:

QuintilesIMS
Cerilliant
Queensland Health
Accenture
Dow
Chubb
US Army
Johnson and Johnson
Cantor Fitzgerald
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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