Generic Epclusa Availability
Last updated on Jan 8, 2025.
Epclusa is a brand name of sofosbuvir/velpatasvir, approved by the FDA in the following formulation(s):
EPCLUSA (sofosbuvir; velpatasvir - pellets;oral)
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Manufacturer: GILEAD SCIENCES INC
Approval date: June 10, 2021
Strength(s): 150MG;37.5MG/PACKET [RLD], 200MG;50MG/PACKET [RLD]
EPCLUSA (sofosbuvir; velpatasvir - tablet;oral)
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Manufacturer: GILEAD SCIENCES INC
Approval date: June 28, 2016
Strength(s): 400MG;100MG [RLD] -
Manufacturer: GILEAD SCIENCES INC
Approval date: March 19, 2020
Strength(s): 200MG;50MG [RLD]
Has a generic version of Epclusa been approved?
No. There is currently no therapeutically equivalent version of Epclusa available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Epclusa. 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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Combination formulation of two antiviral compounds
Patent 10,086,011
Issued: October 2, 2018
Inventor(s): Gorman Eric & Mogalian Erik & Oliyai Reza & Stefanidis Dimitrios & Wiser Lauren & Zia Vahid
Assignee(s): Gilead Pharmasset LLCDisclosed are pharmaceutical compositions comprising Compound I, having the formula:
Patent expiration dates:
- January 30, 2034✓
- January 30, 2034
-
Combination formulation of two antiviral compounds
Patent 10086011*PE
Issued: October 2, 2018
Inventor(s): Gorman Eric & Mogalian Erik & Oliyai Reza & Stefanidis Dimitrios & Wiser Lauren & Zia Vahid
Assignee(s): Gilead Pharmasset LLCDisclosed are pharmaceutical compositions comprising Compound I, having the formula:
Patent expiration dates:
- July 30, 2034
- July 30, 2034
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Patent 11,116,783
Patent expiration dates:
- January 30, 2034✓✓
- January 30, 2034
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Patent 11116783*PE
Patent expiration dates:
- July 30, 2034
- July 30, 2034
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Patent 11,707,479
Patent expiration dates:
- January 30, 2034✓✓
- January 30, 2034
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Patent 11707479*PE
Patent expiration dates:
- July 30, 2034
- July 30, 2034
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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
-
Antiviral compounds
Patent 8,575,135
Issued: November 5, 2013
Inventor(s): Bacon Elizabeth M. & Cottell Jeromy J. & Katana Ashley Anne & Kato Darryl & Krygowski Evan S. & Link John O. & Taylor James & Tran Chinh Viet & Trejo Martin Teresa Alejandra & Yang Zheng-Yu & Zipfel Sheila
Assignee(s): Gilead Sciences, Inc.The disclosure 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:
- November 16, 2032✓✓✓
- November 16, 2032
-
Antiviral compounds
Patent 8575135*PED
Issued: November 5, 2013
Inventor(s): Bacon Elizabeth M. & Cottell Jeromy J. & Katana Ashley Anne & Kato Darryl & Krygowski Evan S. & Link John O. & Taylor James & Tran Chinh Viet & Trejo Martin Teresa Alejandra & Yang Zheng-Yu & Zipfel Sheila
Assignee(s): Gilead Sciences, Inc.The disclosure 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 16, 2033✓
- May 16, 2033
-
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
-
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
-
Nucleoside phosphoramidate prodrugs
Patent 8,735,372
Issued: May 27, 2014
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 8735372*PED
Issued: May 27, 2014
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
-
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
-
Antiviral compounds
Patent 8,921,341
Issued: December 30, 2014
Inventor(s): Bacon Elizabeth M. & Cottell Jeromy J. & Katana Ashley Anne & Kato Darryl & Krygowski Evan S. & Link John O. & Taylor James & Tran Chinh Viet & Trejo Martin Teresa Alejandra & Yang Zheng-Yu & Zipfel Sheila
Assignee(s): Gilead Pharmasset LLCThe disclosure 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:
- November 16, 2032✓✓✓
- November 16, 2032
-
Antiviral compounds
Patent 8921341*PED
Issued: December 30, 2014
Inventor(s): Bacon Elizabeth M. & Cottell Jeromy J. & Katana Ashley Anne & Kato Darryl & Krygowski Evan S. & Link John O. & Taylor James & Tran Chinh Viet & Trejo Martin Teresa Alejandra & Yang Zheng-Yu & Zipfel Sheila
Assignee(s): Gilead Pharmasset LLCThe disclosure 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 16, 2033✓
- May 16, 2033
-
Antiviral compounds
Patent 8,940,718
Issued: January 27, 2015
Inventor(s): Bacon Elizabeth M. & Cottell Jeromy J. & Katana Ashley Anne & Kato Darryl & Krygowski Evan S. & Link John O. & Taylor James & Tran Chinh Viet & Martin Teresa Alejandra Trejo & Yang Zheng-Yu & Zipfel Sheila
Assignee(s): Gilead Pharmasset LLCThe disclosure 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:
- November 16, 2032✓✓✓
- November 16, 2032
-
Antiviral compounds
Patent 8940718*PED
Issued: January 27, 2015
Inventor(s): Bacon Elizabeth M. & Cottell Jeromy J. & Katana Ashley Anne & Kato Darryl & Krygowski Evan S. & Link John O. & Taylor James & Tran Chinh Viet & Martin Teresa Alejandra Trejo & Yang Zheng-Yu & Zipfel Sheila
Assignee(s): Gilead Pharmasset LLCThe disclosure 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 16, 2033✓
- May 16, 2033
-
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
-
Combination formulation of two antiviral compounds
Patent 9,757,406
Issued: September 12, 2017
Inventor(s): Gorman Eric & Mogalian Erik & Oliyai Reza & Stefanidis Dimitrios & Wiser Lauren & Zia Vahid
Assignee(s): Gilead Pharmasset LLCDisclosed are pharmaceutical compositions comprising Compound I, having the formula:
Patent expiration dates:
- January 30, 2034✓
- January 30, 2034
-
Combination formulation of two antiviral compounds
Patent 9757406*PED
Issued: September 12, 2017
Inventor(s): Gorman Eric & Mogalian Erik & Oliyai Reza & Stefanidis Dimitrios & Wiser Lauren & Zia Vahid
Assignee(s): Gilead Pharmasset LLCDisclosed are pharmaceutical compositions comprising Compound I, having the formula:
Patent expiration dates:
- July 30, 2034✓
- July 30, 2034
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:
- July 14, 2023 - INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
- January 14, 2024 - PEDIATRIC EXCLUSIVITY
- April 27, 2025 - UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TRE
- March 19, 2027 - TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
- September 19, 2027 - PEDIATRIC EXCLUSIVITY
- June 10, 2028 - FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIR
- December 10, 2028 - PEDIATRIC EXCLUSIVITY
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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.