Generic Cabenuva Availability
Last updated on Apr 10, 2025.
Cabenuva is a brand name of cabotegravir/rilpivirine, approved by the FDA in the following formulation(s):
CABENUVA KIT (cabotegravir; rilpivirine - suspension, extended release;intramuscular)
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Manufacturer: VIIV HLTHCARE
Approval date: January 21, 2021
Strength(s): 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML) [RLD], 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) [RLD]
Is there a generic version of Cabenuva available?
No. There is currently no therapeutically equivalent version of Cabenuva available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cabenuva. 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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N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity
Patent 10,927,129
Issued: February 23, 2021
Inventor(s): Johns; Brian A. et al.
Assignee(s): SHINOGI & CO., LTD. (Osaka, JP); VIIV HEALTHCARE COMPANY (Research Triangle Park, NC)The present invention is directed to N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide of the formula: ##STR00001##
or a pharmaceutically acceptable salt or stereoisomer thereof, and pharmaceutical compositions comprising the same. The present invention has HIV integrase inhibitory activity.Patent expiration dates:
- April 28, 2026✓✓
- April 28, 2026
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Pharmaceutical compositions
Patent 11,224,597
Issued: January 18, 2022
Inventor(s): Mundhra Deepak B. & Pan Rennan
Assignee(s): ViiV Healthcare CompanyThe present Invention relates to pharmaceutical compositions of (3S,11aR)—N-[(2,4-difluorophenyhmethyl]-2,3,5,7,11,11a-hexahydro-6-hydroxy-3-methyl-5,7-dioxo-oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide, useful in the treatment or prevention of Human Immunodeficiency Virus (HIV) infections.
Patent expiration dates:
- September 15, 2031✓✓
- September 15, 2031
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Aqueous suspensions of TMC278
Patent 11,389,447
Issued: July 19, 2022
Inventor(s): Baert; Lieven Elvire Colette et al.
Assignee(s): Janssen Sciences Ireland Unlimited Company (County Cork, IE)This invention concerns pharmaceutical compositions for administration via intramuscular or subcutaneous injection, comprising micro- or nanoparticles of the NNRTI compound TMC278, suspended in an aqueous pharmaceutically acceptable carrier, and the use of such pharmaceutical compositions in the treatment and prophylaxis of HIV infection.
Patent expiration dates:
- June 30, 2027✓
- June 30, 2027
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Pharmaceutical compositions
Patent 12,138,264
Issued: November 12, 2024
Inventor(s): Mundhra; Deepak B. et al.
Assignee(s): ViiV Healthcare Company (Wilmington, DE)The present Invention relates to pharmaceutical compositions of (3S, 11aR)-N-[(2,4-difluorophenyl)methyl]-2,3,5,7,11,11a-hexahydro-6-hydroxy-3-methyl-5,7-dioxo-oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide, useful in the treatment or prevention of Human Immunodeficiency Virus (HIV) infections.
Patent expiration dates:
- September 15, 2031✓✓
- September 15, 2031
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Regimens for treating HIV infections and aids
Patent 12,178,815
Issued: December 31, 2024
Inventor(s): Crauwels; Herta et al.
Assignee(s): ViiV Healthcare Company (Wilmington, DE); Janssen Sciences Ireland Unlimited Company (N/A, IE)A method of treating HIV comprising intramuscular administration once every 4 weeks or less frequently of a combination of cabotegravir or a pharmaceutically acceptable salt thereof and rilpivirine or a pharmaceutically acceptable salt thereof, including the option of discontinuing administration of a first oral anti-retroviral regimen and intramuscularly administering, once four weeks or less often said combination of cabotegravir and rilpivirine.
Patent expiration dates:
- July 18, 2038✓
- July 18, 2038
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HIV inhibiting pyrimidines derivatives
Patent 7,125,879
Issued: October 24, 2006
Inventor(s): Guillemont; Jerome Emile Georges et al.
Assignee(s): Janssen Pharmaceutica N.V. (Beerse, BE)This invention concerns HIV replication inhibitors of formula (I) the N-oxides, the pharmaceutically acceptable addition salts, the quaternary amines and the stereochemically isomeric forms thereof, wherein the ring containing -a.sup.1=a.sup.2-a.sup.3=a.sup.4--and -b.sup.1=b.sup.2-b.sup.3=b.sup.4represents pheynl, pyridyl, pyrimidinyl, pirazinyl, pyridazinyl; n is 0 to 5; m is 1 to 4; R.sup.1 is hydrogen; aryl; formyl; C.sub.1-6alkylcarbonyl; C.sup.1-6alkyl; C.sub.1-6alkyloxycarbonyl, substituted C.sub.1-6alkyl, C.sub.1-6alkylcarbonyl; R.sup.2 is hydroxy, halo, optionally substituted C.sub.1-6alkyl, C.sub.3-7cycloalkyl, optionally substituted C.sub.2-6alkenyl, optionally substituted C.sub.2-6alkynyl, C.sub.1-6alkyloxy, C.sub.1-6alkyloxycarbonyl, carboxyl, cyano, nitro, amino, mono- or di(C.sub.1-6alkyl)amino, polyhalomethyl, polyhalomethyloxy, polyhalomethylthio, --S(.dbd.O).sub.pR.sup.6, --NH--S(.dbd.O).sub.pR.sup.6, --C(.dbd.O)R.sup.6, --NHC(.dbd.O)H, --C(.dbd.O)NHNH?2?, --NHC(.dbd.O)R.sup.6, --C(.dbd.NH)R.sup.6 or a 5-membered hetrocycl; X.sub.1 is --NR.sup.5--, --NH--NH--, --N.dbd.N--, --O--, --C(.dbd.O)--, C.sub.1-4alkanediyl, --CHOH--, --S--, --S(.dbd.O).sub.p--, --X.sub.2--C.sub.1-4alkanediyl- or --C.sub.1-4alkanediyl-X.sub.2--; R.sup.3 is NHR.sup.13, NR.sup.13R.sup.14; --C(.dbd.O)--NHR.sup.13; --C(.dbd.O)--NR.sup.13R.sup.14; --C(.dbd.O)--R.sup.15; --CH.dbd.N--NH--C(.dbd.O)--R.sup.16; substituted C.sub.1-6alkyl; optionally substituted C.sub.1-6alkyloxyC.sub.1-6alkyl; substituted C.sub.2-6alkenyl; substituted C.sub.2-6alkynyl; substituted C.sub.2-6alkylenyl; C.sub.1-6alkyl substituted with hydroxy and a second substituent; --C(.dbd.N--O--R.sup.8)--C.sub.1-4alkyl; R.sup.7; or --X.sub.3--R.sup.7; R.sup.4 is halo, hydroxy, C.sub.1-6alkyl, C.sub.3-7cycloalkyl, C.sub.1-6alkyloxy, cyano, nitro, polyhaloC.sub.1-6alkyl, polyhaloC.sub.1-6alkyloxy, aminocarbonyl, C.sub.1-6alkyloxycarbonyl, C.sub.1-6alkylcarbonyl, formyl, amino, mono- or di(C.sub.1-4alkyl) amino; their use as a medicine, their processes for preparation and pharmaceutical compositions comprising them ##STR00001##
Patent expiration dates:
- April 21, 2025✓✓✓
- April 21, 2025
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(3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
Patent 8,410,103
Issued: April 2, 2013
Inventor(s): Johns; Brian Alvin et al.
Assignee(s): Shionogi & Co., Ltd. (Osaka, JP); VIIV Healthcare Company (Research Triangle Park, NC)The present invention is directed to a substituted 2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2 -a]pyrido[1,2-d]pyrazine-5,7-dione useful as an anti-HIV agent, which has the formula: ##STR00001## as well as pharmaceutically acceptable salts thereof, compostions thereof, and methods of use thereof.
Patent expiration dates:
- April 28, 2026✓✓✓
- April 28, 2026
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Long term treatment of HIV-infection with TMC278
Patent RE50189
Issued: October 29, 2024
Inventor(s): Baert; Lieven Elvire Colette et al.
Assignee(s): Janssen Sciences Ireland Unlimited Company (County Cork, IE)This invention relates to the use of a parenteral formulation comprising an anti-virally effective amount of TMC278 or a pharmaceutically acceptable acid-addition salt thereof, and a carrier, for the manufacture of a medicament for the treatment of a subject being infected with HIV, wherein the formulation is to be administered intermittently at a time interval of at least one week.
Patent expiration dates:
- November 27, 2031✓
- November 27, 2031
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:
- January 31, 2025 - NEW DOSING SCHEDULE FOR CABOTEGRAVIR/RILPIVRINE INJECTION EVERY 2 MONTHS
- March 29, 2025 - NEW PATIENT POPULATION
- January 21, 2026 - NEW CHEMICAL ENTITY
More about Cabenuva (cabotegravir / rilpivirine)
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- During pregnancy
- FDA approval history
- Drug class: antiviral combinations
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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
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