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Generic Harvoni Availability

Last updated on Sep 8, 2021.

Harvoni is a brand name of ledipasvir/sofosbuvir, approved by the FDA in the following formulation(s):

HARVONI (ledipasvir; sofosbuvir - pellets;oral)

  • Manufacturer: GILEAD SCIENCES INC
    Approval date: August 28, 2019
    Strength(s): 33.75MG;150MG/PACKET [RLD], 45MG;200MG/PACKET [RLD]

HARVONI (ledipasvir; sofosbuvir - tablet;oral)

  • Manufacturer: GILEAD SCIENCES INC
    Approval date: October 10, 2014
    Strength(s): 90MG;400MG [RLD]
  • Manufacturer: GILEAD SCIENCES INC
    Approval date: August 28, 2019
    Strength(s): 45MG;200MG [RLD]

Has a generic version of Harvoni been approved?

An Authorized Generic version of Harvoni has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • Ledipasvir and Sofosbuvir ORAL TABLET, FILM COATED 90; 400 mg/1; mg
    Asegua Therapeutics LLC
    NDC Code: 726262601

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Harvoni. 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: Generic Drug FAQ.

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.

  • Combination formulation of two antiviral compounds
    Patent 10,039,779
    Issued: August 7, 2018
    Assignee(s): Gilead Pharmasset LLC

    Disclosed are pharmaceutical compositions having an effective amount of substantially amorphous ledipasvir and an effective amount of substantially crystalline sofosbuvir.

    Patent expiration dates:

    • January 30, 2034
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
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      Drug product
    • January 30, 2034
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      Patent use: FOR THE TREATMENT OF GENOTYPE 1, 4, 5 OR 6 CHRONIC HEPATITIS C VIRUS (HCV) INFECTION
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      Drug substance
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      Drug product
    • January 30, 2034
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      Patent use: FOR TREATMENT-NAIVE GENOTYPE 1 PATIENTS WITH CHRONIC HEPATITIS C VIRUS (HCV) INFECTION FOR A DURATION OF 8-WEEKS
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      Drug substance
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      Drug product
  • Patent 10039779*

    Patent expiration dates:

    • July 30, 2034
  • Patent 10,456,414

    Patent expiration dates:

    • September 14, 2032
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      Drug product
  • Nucleoside phosphoramidate prodrugs
    Patent 7,964,580
    Issued: June 21, 2011
    Inventor(s): Sofia; Michael Joseph & Du; Jinfa & Wang; Peiyuan
    Assignee(s): Pharmasset, Inc.

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 26, 2029
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
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      Drug product
    • September 26, 2029
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      Pediatric exclusivity
  • Antiviral compounds
    Patent 8,088,368
    Issued: January 3, 2012
    Inventor(s): Guo; Hongyan & Kato; Darryl & Kirschberg; Thorsten A. & Liu; Hongtao & Link; John O. & Mitchell; Michael L. & Parrish; Jay P. & Sun; Jianyu & Taylor; James & Bacon; Elizabeth M. & Canales; Eda & Cho; Aesop & Kim; Choung U. & Cottell; Jeromy J. & Desai; Manoj C. & Halcomb; Randall L. & L
    Assignee(s): Gilead Sciences, Inc.

    The invention is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.

    Patent expiration dates:

    • May 12, 2030
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      Drug substance
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      Drug product
    • November 12, 2030
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      Pediatric exclusivity
  • Antiviral compounds
    Patent 8,273,341
    Issued: September 25, 2012
    Inventor(s): Guo; Hongyan & Kato; Darryl & Kirschberg; Thorsten A. & Liu; Hongtao & Link; John O. & Mitchell; Michael L. & Parrish; Jay P. & Graupe; Michael & Sun; Jianyu & Taylor; James & Bacon; Elizabeth M. & Canales; Eda & Cho; Aesop & Kim; Choung U. & Cottell; Jeromy J. & Desai; Manoj C. & Halco
    Assignee(s): Gilead Sciences, Inc.

    The invention is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.

    Patent expiration dates:

    • May 12, 2030
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
    • November 12, 2030
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      Pediatric exclusivity
  • Nucleoside phosphoramidate prodrugs
    Patent 8,334,270
    Issued: December 18, 2012
    Inventor(s): Sofia; Michael Joseph & Du; Jinfa & Wang; Peiyuan & Nagarathnam; Dhanapalan
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 21, 2028
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
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      Drug product
    • September 21, 2028
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      Pediatric exclusivity
  • Nucleoside phosphoramidate prodrugs
    Patent 8,580,765
    Issued: November 12, 2013
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 21, 2028
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
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      Drug product
    • September 21, 2028
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      Pediatric exclusivity
  • Nucleoside phosphoramidates
    Patent 8,618,076
    Issued: December 31, 2013
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are nucleoside phosphoramidates and their use as agents for treating viral diseases. These compounds are inhibitors of RNA-dependent RNA viral replication and are useful as inhibitors of HCV NS5B polymerase, as inhibitors of HCV replication and for treatment of hepatitis C infection in mammals.

    Patent expiration dates:

    • December 11, 2030
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
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      Drug product
    • June 11, 2031
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      Pediatric exclusivity
  • Nucleoside phosphoramidates
    Patent 8,633,309
    Issued: January 21, 2014
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are nucleoside phosphoramidates and their use as agents for treating viral diseases. These compounds are inhibitors of RNA-dependent 5 RNA viral replication and are useful as inhibitors of HCV NS5B polymerase, as inhibitors of HCV replication and for treatment of hepatitis C infection in mammals.

    Patent expiration dates:

    • March 26, 2029
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
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      Drug product
    • September 26, 2029
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      Pediatric exclusivity
  • Nucleoside phosphoramidate prodrugs
    Patent 8,735,372
    Issued: May 27, 2014
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 21, 2028
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
    • September 21, 2028
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      Pediatric exclusivity
  • Antiviral compounds
    Patent 8,822,430
    Issued: September 2, 2014
    Assignee(s): Gilead Pharmasset LLC

    The invention is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.

    Patent expiration dates:

    • May 12, 2030
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
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      Drug product
    • November 12, 2030
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      Pediatric exclusivity
  • Antiviral compounds
    Patent 8,841,278
    Issued: September 23, 2014
    Assignee(s): Gilead Pharmasset LLC

    The invention is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.

    Patent expiration dates:

    • May 12, 2030
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug product
    • November 12, 2030
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      Pediatric exclusivity
  • Compositions and methods for treating hepatitis C virus
    Patent 8,889,159
    Issued: November 18, 2014
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are a composition and unit dosage form for the treatment of hepatitis C virus (HCV) infection comprising GS-7977 and at least one pharmaceutically acceptable excipient, as well as methods for making said composition and unit dosage form. Also disclosed herein is a method of treating a subject, preferably a human, infected with hepatitis C virus, said method comprising administering to the subject for a time period an effective amount of GS-7977 and an effective amount of ribavirin. In one aspect, the method comprises administering to the subject an interferon-free treatment regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In a particular aspect, the method is sufficient to produce an undetectable amount of HCV RNA in the subject for at least 12 weeks after the end of the time period.

    Patent expiration dates:

    • March 26, 2029
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug product
    • September 26, 2029
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      Pediatric exclusivity
  • Nucleoside phosphoramidate prodrugs
    Patent 9,085,573
    Issued: July 21, 2015
    Assignee(s): GILEAD PHARMASSET LLC

    Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.

    Patent expiration dates:

    • March 21, 2028
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
      ✓ 
      Drug product
    • September 21, 2028
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      Pediatric exclusivity
  • Nucleoside phosphoramidates
    Patent 9,284,342
    Issued: March 15, 2016
    Assignee(s): Gilead Pharmasset LLC

    Disclosed herein are nucleoside phosphoramidates and their use as agents for treating viral diseases. These compounds are inhibitors of RNA-dependent RNA viral replication and are useful as inhibitors of HCV NS5B polymerase, as inhibitors of HCV replication and for treatment of hepatitis C infection in mammals.

    Patent expiration dates:

    • September 13, 2030
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
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      Drug substance
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      Drug product
    • March 13, 2031
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      Pediatric exclusivity
  • Methods for treating HCV
    Patent 9,393,256
    Issued: July 19, 2016
    Assignee(s): Gilead Pharmasset LLC

    This invention relates to combinations of therapeutic molecules useful for treating hepatitis C virus infection. The present invention relates to methods, uses, dosing regimens, and compositions.

    Patent expiration dates:

    • September 14, 2032
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      Patent use: FOR THE TREATMENT OF HEPATITIS C
    • March 14, 2033
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      Pediatric exclusivity
  • Antiviral compounds
    Patent 9,511,056
    Issued: December 6, 2016
    Assignee(s): Gilead Pharmasset LLC

    The invention is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.

    Patent expiration dates:

    • May 12, 2030
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
    • May 12, 2030
      ✓ 
      Patent use: FOR THE TREATMENT OF HEPATITIS C
      ✓ 
      Drug product
    • November 12, 2030
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      Pediatric exclusivity

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:

    • November 15, 2022 - INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS
    • April 7, 2024 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
    • April 7, 2024 -
    • October 7, 2024 - PEDIATRIC EXCLUSIVITY
    • August 28, 2026 -
    • August 28, 2026 -
    • August 28, 2026 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
    • August 28, 2026 -

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.