Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Covington
Fuji
Harvard Business School
Julphar
Merck
Baxter
Boehringer Ingelheim
Cantor Fitzgerald
Farmers Insurance

Generated: December 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206843

« Back to Dashboard

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
Generic Entry Opportunity Date for 206843
Generic Entry Date for 206843*:
Constraining patent/regulatory exclusivity:
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.

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)

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Colorcon
McKesson
Federal Trade Commission
Argus Health
Boehringer Ingelheim
Dow
Chubb
Cipla

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.