Generic Sunlenca Availability
Last updated on Apr 10, 2025.
Sunlenca is a brand name of lenacapavir, approved by the FDA in the following formulation(s):
SUNLENCA (lenacapavir sodium - solution;subcutaneous)
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Manufacturer: GILEAD SCIENCES INC
Approval date: December 22, 2022
Strength(s): EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) [RLD]
SUNLENCA (lenacapavir sodium - tablet;oral)
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Manufacturer: GILEAD SCIENCES INC
Approval date: December 22, 2022
Strength(s): EQ 300MG BASE [RLD]
Is there a generic version of Sunlenca available?
No. There is currently no therapeutically equivalent version of Sunlenca available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Sunlenca. 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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Therapeutic compounds
Patent 10,071,985
Issued: September 11, 2018
Inventor(s): Graupe Michael & Henry Steven J. & Link John O. & Rowe Charles William & Saito Roland D. & Schroeder Scott D. & Stefanidis Dimitrios & Tse Winston C. & Zhang Jennifer R.
Assignee(s): Gilead Sciences, Inc.The present disclosure relates to a compound of formula (Ia), (Ib), (IIa), and (IIb):
Patent expiration dates:
- August 17, 2037✓✓
- August 17, 2037
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Therapeutic compounds
Patent 10,654,827
Issued: May 19, 2020
Inventor(s): Graupe Michael & Henry Steven J. & Link John O. & Saito Roland D. & Schroeder Scott D. & Stefanidis Dimitrios & Tse Winston C. & Zhang Jennifer R.
Assignee(s): Gilead Sciences, Inc.The present disclosure relates to a compound of formula (Ia), (Ib), (IIa), and (IIb):
Patent expiration dates:
- August 17, 2037✓
- August 17, 2037
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Solid forms of an HIV capsid inhibitor
Patent 11,267,799
Issued: March 8, 2022
Inventor(s): Shi Bing
Assignee(s): Gilead Sciences, Inc.The present disclosure relates to pharmaceutically acceptable salts, cocrystals, and crystalline forms thereof, of a compound which is N—((S)-1-(3-(4-chloro-3-(methylsulfonamido)-1-(2,2,2-trifluoroethyl)-1H-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)but-1-yn-1-yl)pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl)-2- ((3bS,4aR)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1H-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl)acetamide, which is useful in the treatment of a Retroviridae viral infection including an infection caused by the HIV virus.
Patent expiration dates:
- August 16, 2038✓
- August 16, 2038
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Capsid inhibitors for the treatment of HIV
Patent 11,944,611
Issued: April 2, 2024
Inventor(s): Bauer; Laura Elizabeth et al.
Assignee(s): Gilead Sciences, Inc. (Foster City, CA)The present disclosure relates to compounds of Formula (Ia) and (Ib): ##STR00001##
or a pharmaceutically acceptable salt thereof, which are useful in the treatment of an HIV infection in heavily treatment-experienced patients with multidrug resistant HIV infection.Patent expiration dates:
- August 28, 2041✓
- August 28, 2041
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Therapeutic compounds
Patent 9,951,043
Issued: April 24, 2018
Inventor(s): Brizgys Gediminas & Canales Eda & Chou Chien-hung & Graupe Michael & Halcomb Randall L. & Hu Yunfeng Eric & Lazerwith Scott E. & Link John O. & Liu Qi & Lu Yafan & Saito Roland D. & Schroeder Scott D. & Somoza John R. & Tse Winston C. & Zhang Jennifer R.
Assignee(s): Gilead Sciences, Inc.Compounds of formula (I) or salts thereof are disclosed. Also disclosed are pharmaceutical compositions comprising a compound of formula I, processes for preparing compounds of formula I, intermediates useful for preparing compounds of formula I and therapeutic methods for treating a Retroviridae viral infection including an infection caused by the HIV virus.
Patent expiration dates:
- February 28, 2034✓✓✓
- February 28, 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:
- December 22, 2027 - NEW CHEMICAL ENTITY
More about Sunlenca (lenacapavir)
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- Drug class: miscellaneous antivirals
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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.
