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Generic Daklinza Availability

Daklinza is a brand name of daclatasvir, approved by the FDA in the following formulation(s):

DAKLINZA (daclatasvir dihydrochloride - tablet;oral)

  • Manufacturer: BRISTOL-MYERS SQUIBB
    Approval date: July 24, 2015
    Strength(s): EQ 30MG BASE, EQ 60MG BASE [RLD]
  • Manufacturer: BRISTOL-MYERS SQUIBB
    Approval date: April 13, 2016
    Strength(s): EQ 90MG BASE

Has a generic version of Daklinza been approved?

No. There is currently no therapeutically equivalent version of Daklinza available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Daklinza. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Hepatitis C virus inhibitors
    Patent 8,329,159
    Issued: December 11, 2012
    Inventor(s): Belema; Makonen & Nguyen; Van N.
    Assignee(s): Bristol-Myers Squibb Company
    The present disclosure relates to compounds, compositions and methods for the treatment of hepatitis C virus (HCV) infection. Also disclosed are pharmaceutical compositions containing such compounds and methods for using these compounds in the treatment of HCV infection.
    Patent expiration dates:
    • April 13, 2028
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      Drug substance
  • Crystalline form of methyl ((1S)-1-((25)-2-(5-(4'-(2-((25)-1((2S)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-2-pyrrolidinyl)-1H-imidazol-2-yl)-1-pyrrolidinyl)carbonyl)-2-methylpropyl)carbamate dihydrochloride salt
    Patent 8,629,171
    Issued: January 14, 2014
    Assignee(s): Bristol-Myers Squibb Company
    The present disclosure generally relates to a crystalline form of methyl ((1S)-1-(((2S)-2-(5-(4′-(2-((2S)-1-((2S)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-2-pyrrolidinyl)-1H-imidazol-5-yl)-4-biphenylyl)-1H-imidazol-2-yl)-1-pyrrolidinyl)carbonyl)-2-methylpropyl)carbamate dihydrochloride salt. The present disclosure also generally relates to a pharmaceutical composition comprising a crystalline form, as well of methods of using a crystalline form in the treatment of Hepatitis C and methods for obtaining such crystalline form.
    Patent expiration dates:
    • June 13, 2031
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      Patent use: METHOD OF INHIBITING HEPATITIS C VIRUS
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      Drug substance
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      Drug product
  • Hepatitis C virus inhibitors
    Patent 8,642,025
    Issued: February 4, 2014
    Assignee(s): Bristol-Myers Squibb Company
    The present disclosure relates to compounds, compositions and methods for the treatment of hepatitis C virus (HCV) infection. Also disclosed are pharmaceutical compositions containing such compounds and methods for using these compounds in the treatment of HCV infection.
    Patent expiration dates:
    • August 11, 2027
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      Patent use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
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      Drug substance
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      Drug product
    • August 11, 2027
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      Patent use: METHOD OF INHIBITING HEPATITIS C VIRUS
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      Drug substance
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      Drug product
  • Hepatitis C virus inhibitors
    Patent 8,900,566
    Issued: December 2, 2014
    Assignee(s): Bristol-Myers Squibb Company
    The present disclosure relates to compounds, compositions and methods for the treatment of hepatitis C virus (HCV) infection. Also disclosed are pharmaceutical compositions containing such compounds and methods for using these compounds in the treatment of HCV infection.
    Patent expiration dates:
    • August 8, 2027
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      Patent use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
    • August 8, 2027
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      Patent use: METHOD OF INHIBITING HEPATITIS C VIRUS
  • Hepatitis C virus inhibitors
    Patent 9,421,192
    Issued: August 23, 2016
    Assignee(s): Bristol-Myers Squibb Company
    The present disclosure relates to compounds, compositions and methods for the treatment of hepatitis C virus (HCV) infection. Also disclosed are pharmaceutical compositions containing such compounds and methods for using these compounds in the treatment of HCV infection.
    Patent expiration dates:
    • August 8, 2027
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      Patent use: METHOD OF INHIBITING HEPATITIS C VIRUS
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      Drug substance
    • August 8, 2027
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      Patent use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
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      Drug substance

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • February 5, 2019 - 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
    • February 5, 2019 - EXPANSION OF THE PATIENT POPULATION TO INCLUDE PATIENTS WITH RECURRENCE OF HEPATITIS C VIRUS (HCV) GENOTYPE 1 OR 3 AFTER LIVER TRANSPLANTATION
    • February 5, 2019 - DOSAGE RECOMMENDATIONS ADDED TO INCLUDE TREATMENT OF HCV GENOTYPE 3 SUBJECTS CO-INFECTED WITH HIV-1
    • February 5, 2019 - 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
    • July 24, 2020 - NEW CHEMICAL ENTITY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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