Generic Sovaldi Availability
Last updated on Apr 10, 2024.
Sovaldi is a brand name of sofosbuvir, approved by the FDA in the following formulation(s):
SOVALDI (sofosbuvir - pellets;oral)
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Manufacturer: GILEAD SCIENCES INC
Approval date: August 28, 2019
Strength(s): 150MG/PACKET [RLD], 200MG/PACKET [RLD]
SOVALDI (sofosbuvir - tablet;oral)
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Manufacturer: GILEAD SCIENCES INC
Approval date: December 6, 2013
Strength(s): 400MG [RLD] -
Manufacturer: GILEAD SCIENCES INC
Approval date: August 28, 2019
Strength(s): 200MG [RLD]
Has a generic version of Sovaldi been approved?
No. There is currently no therapeutically equivalent version of Sovaldi available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sovaldi. 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.
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Patent 7,964,580
Patent expiration dates:
- March 26, 2029✓✓✓
- March 26, 2029
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Patent 7964580*PED
Patent expiration dates:
- September 26, 2029✓
- September 26, 2029
-
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 LLCDisclosed 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:
Patent expiration dates:
- March 21, 2028✓✓✓
- March 21, 2028
-
Nucleoside phosphoramidate prodrugs
Patent 8334270*PED
Issued: December 18, 2012
Inventor(s): Sofia Michael Joseph & Du Jinfa & Wang Peiyuan & Nagarathnam Dhanapalan
Assignee(s): Gilead Pharmasset LLCDisclosed 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:
Patent expiration dates:
- September 21, 2028✓
- September 21, 2028
-
Nucleoside phosphoramidate prodrugs
Patent 8,580,765
Issued: November 12, 2013
Inventor(s): Sofia Michael Joseph & Du Jinfa & Wang Peiyuan & Nagarathnam Dhanapalan
Assignee(s): Gilead Pharmasset LLCDisclosed 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:
Patent expiration dates:
- March 21, 2028✓✓✓
- March 21, 2028
-
Nucleoside phosphoramidate prodrugs
Patent 8580765*PED
Issued: November 12, 2013
Inventor(s): Sofia Michael Joseph & Du Jinfa & Wang Peiyuan & Nagarathnam Dhanapalan
Assignee(s): Gilead Pharmasset LLCDisclosed 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:
Patent expiration dates:
- September 21, 2028✓
- September 21, 2028
-
Nucleoside phosphoramidates
Patent 8,618,076
Issued: December 31, 2013
Inventor(s): Ross Bruce S. & Sofia Michael Joseph & Pamulapati Ganapati Reddy & Rachakonda Suguna & Zhang Hai-Ren & Chun Byoung-Kwon & Wang Peiyuan
Assignee(s): Gilead Pharmasset LLCDisclosed 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✓✓✓
- December 11, 2030
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Nucleoside phosphoramidates
Patent 8618076*PED
Issued: December 31, 2013
Inventor(s): Ross Bruce S. & Sofia Michael Joseph & Pamulapati Ganapati Reddy & Rachakonda Suguna & Zhang Hai-Ren & Chun Byoung-Kwon & Wang Peiyuan
Assignee(s): Gilead Pharmasset LLCDisclosed 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:
- June 11, 2031✓
- June 11, 2031
-
Nucleoside phosphoramidates
Patent 8,633,309
Issued: January 21, 2014
Inventor(s): Ross Bruce & Sofia Michael Joseph & Pamulapati Ganapati Reddy & Rachakonda Suguna & Zhang Hai-Ren & Chun Byoung-Kwon & Wang Peiyuan
Assignee(s): Gilead Pharmasset LLCDisclosed 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✓✓✓
- March 26, 2029
-
Nucleoside phosphoramidates
Patent 8633309*PED
Issued: January 21, 2014
Inventor(s): Ross Bruce & Sofia Michael Joseph & Pamulapati Ganapati Reddy & Rachakonda Suguna & Zhang Hai-Ren & Chun Byoung-Kwon & Wang Peiyuan
Assignee(s): Gilead Pharmasset LLCDisclosed 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:
- September 26, 2029✓
- September 26, 2029
-
Compositions and methods for treating hepatitis C virus
Patent 8,889,159
Issued: November 18, 2014
Inventor(s): Cleary Darryl G. & Reynolds Charles J. & Berrey Miriam Michelle & Hindes Robert G. & Symonds William T. & Ray Adrian S. & Mo Hongmei & Hebner Christy M. & Oliyai Reza & Zia Vahid & Stefanidis Dimitrios & Pakdaman Rowchanak & Casteel Melissa Jean
Assignee(s): Gilead Pharmasset LLCDisclosed 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✓✓
- March 26, 2029
-
Compositions and methods for treating hepatitis C virus
Patent 8889159*PED
Issued: November 18, 2014
Inventor(s): Cleary Darryl G. & Reynolds Charles J. & Berrey Miriam Michelle & Hindes Robert G. & Symonds William T. & Ray Adrian S. & Mo Hongmei & Hebner Christy M. & Oliyai Reza & Zia Vahid & Stefanidis Dimitrios & Pakdaman Rowchanak & Casteel Melissa Jean
Assignee(s): Gilead Pharmasset LLCDisclosed 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:
- September 26, 2029✓
- September 26, 2029
-
Nucleoside phosphoramidate prodrugs
Patent 9,085,573
Issued: July 21, 2015
Inventor(s): Du Jinfa & Nagarathnam Dhanapalan & Sofia Michael Joseph & Wang Peiyuan
Assignee(s): GILEAD PHARMASSET LLCDisclosed 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:
Patent expiration dates:
- March 21, 2028✓✓✓
- March 21, 2028
-
Nucleoside phosphoramidate prodrugs
Patent 9085573*PED
Issued: July 21, 2015
Inventor(s): Du Jinfa & Nagarathnam Dhanapalan & Sofia Michael Joseph & Wang Peiyuan
Assignee(s): GILEAD PHARMASSET LLCDisclosed 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:
Patent expiration dates:
- September 21, 2028✓
- September 21, 2028
-
Nucleoside phosphoramidates
Patent 9,284,342
Issued: March 15, 2016
Inventor(s): Ross Bruce S. & Sofia Michael Joseph & Pamulapati Ganapati Reddy & Rachakonda Suguna & Zhang Hai-Ren & Chun Byoung-Kwon & Wang Peiyuan
Assignee(s): Gilead Pharmasset LLCDisclosed 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✓✓✓
- September 13, 2030
-
Nucleoside phosphoramidates
Patent 9284342*PED
Issued: March 15, 2016
Inventor(s): Ross Bruce S. & Sofia Michael Joseph & Pamulapati Ganapati Reddy & Rachakonda Suguna & Zhang Hai-Ren & Chun Byoung-Kwon & Wang Peiyuan
Assignee(s): Gilead Pharmasset LLCDisclosed 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:
- March 13, 2031✓
- March 13, 2031
-
Compositions and methods for treating hepatitis C virus
Patent 9,549,941
Issued: January 24, 2017
Inventor(s): Cleary Darryl G. & Reynolds Charles J. & Berrey Miriam Michelle & Hindes Robert G. & Symonds William T. & Ray Adrian S. & Mo Hongmei & Hebner Christy M. & Oliyai Reza & Zia Vahid & Stefanidis Dimitrios & Pakdaman Rowchanak & Casteel Melissa Jean
Assignee(s): Gilead Pharmasset LLCDisclosed 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✓
- March 26, 2029
-
Compositions and methods for treating hepatitis C virus
Patent 9549941*PED
Issued: January 24, 2017
Inventor(s): Cleary Darryl G. & Reynolds Charles J. & Berrey Miriam Michelle & Hindes Robert G. & Symonds William T. & Ray Adrian S. & Mo Hongmei & Hebner Christy M. & Oliyai Reza & Zia Vahid & Stefanidis Dimitrios & Pakdaman Rowchanak & Casteel Melissa Jean
Assignee(s): Gilead Pharmasset LLCDisclosed 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:
- September 26, 2029✓
- September 26, 2029
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:
- April 7, 2024 - TREATMENT OF CHRONIC HCV GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
- 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
- October 7, 2024 - PEDIATRIC EXCLUSIVITY
- August 28, 2026 - FOR THE TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
- 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
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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.