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Generic Isentress Availability

Last updated on Mar 9, 2023.

See also: Generic Isentress HD

Isentress is a brand name of raltegravir, approved by the FDA in the following formulation(s):

ISENTRESS (raltegravir potassium - powder;oral)

  • Manufacturer: MSD SUB MERCK
    Approval date: December 20, 2013
    Strength(s): EQ 100MG BASE/PACKET [RLD]

ISENTRESS (raltegravir potassium - tablet, chewable;oral)

  • Manufacturer: MSD SUB MERCK
    Approval date: December 21, 2011
    Strength(s): EQ 25MG BASE [RLD], EQ 100MG BASE [RLD]

ISENTRESS (raltegravir potassium - tablet;oral)

  • Manufacturer: MSD SUB MERCK
    Approval date: October 12, 2007
    Strength(s): EQ 400MG BASE [RLD]

Has a generic version of Isentress been approved?

No. There is currently no therapeutically equivalent version of Isentress available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Isentress. 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.

  • N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
    Patent 7,169,780
    Issued: January 30, 2007
    Inventor(s): Crescenzi; Benedetta & Gardelli; Cristina & Muraglia; Ester & Orvieto; Federica & Pace; Paola & Pescatore; Giovanna & Petrocchi; Alessia & Poma; Marco & Rowley; Michael & Scarpelli; Rita & Summa; Vincenzo & Nizi; Emanuela
    Assignee(s): Istitute Di Ricerche Di Biologia Molecolare P. Angeletti S.P.A.

    N-substituted 5-hydroxypyrimidin-6-one-4-carboxamides of formula (I): are described as inhibitors of HIV integrase and inhibitors of HIV replication, wherein R1, R2, R3 and R4 are defined herein. These compounds are useful in the prevention and treatment of infection by HIV and in the prevention, delay in the onset, and treatment of AIDS. The compounds are employed against HIV infection and AIDS as compounds per se or in the form of pharmaceutically acceptable salts. The compounds and their salts can be employed as ingredients in pharmaceutical compositions, optionally in combination with other antivirals, immunomodulators, antibiotics or vaccines. Methods of preventing, treating or delaying the onset of AIDS and methods of preventing or treating infection by HIV are also described

    Patent expiration dates:

    • October 3, 2023
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 3, 2024
      ✓ 
      Pediatric exclusivity
  • N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
    Patent 7,217,713
    Issued: May 15, 2007
    Inventor(s): Crescenzi; Benedetta & Gardelli; Cristina & Muraglia; Ester & Nizi; Emanuela & Orvieto; Federica & Pace; Paola & Pescatore; Giovanna & Petrocchi; Alessia & Poma; Marco & Rowley; Michael & Scarpelli; Rita & Summa; Vincenzo
    Assignee(s): Istituto Di Richerche Di Biologia Molecolare P. Angeletti S.p.A.

    N-substituted 5-hydroxypyrimidin-6-one-4-carboxamides of formula: are described as inhibitors of HIV integrase and inhibitors of HIV replication, wherein R1, R2, R3 and R4 are defined herein. These compounds are useful in the prevention and treatment of infection by HIV and in the prevention, delay in the onset, and treatment of AIDS. The compounds-are employed against HIV infection and AIDS as compounds per se or in the form of pharmaceutically acceptable salts. The compounds and their salts can be employed as ingredients in pharmaceutical compositions, optionally in combination with other antivirals, immunomodulators, antibiotics or vaccines. Methods of preventing, treating or delaying the onset of AIDS and methods of preventing or treating infection by HIV are also described.

    Patent expiration dates:

    • April 21, 2023
      ✓ 
      Pediatric exclusivity
  • N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
    Patent 7,435,734
    Issued: October 14, 2008
    Inventor(s): Crescenzi; Benedetta & Gardelli; Cristina & Muraglia; Ester & Nizi; Emanuela & Orvieto; Federica & Pace; Paola & Pescatore; Giovanna & Petrocchi; Alessia & Poma; Marco & Rowley; Michael & Scarpelli; Rita & Summa; Vincenzo
    Assignee(s): Istituto di Ricerche di Biologia Molecolare P. Angeletti S.p.A.

    N-substituted 5-hydroxypyrimidin-6-one-4-carboxamides of formula: are described as inhibitors of HIV integrase and inhibitors of HIV replication, wherein R1, R2, R3 and R4 are defined herein. These compounds are useful in the prevention and treatment of infection by HIV and in the prevention, delay in the onset, and treatment of AIDS. The compounds are employed against HIV infection and AIDS as compounds per se or in the form of pharmaceutically acceptable salts. The compounds and their salts can be employed as ingredients in pharmaceutical compositions, optionally in combination with other antivirals, immunomodulators, antibiotics or vaccines. Methods of preventing, treating or delaying the onset of AIDS and methods of preventing or treating infection by HIV are also described.

    Patent expiration dates:

    • April 21, 2023
      ✓ 
      Pediatric exclusivity
  • Potassium salt of an HIV integrase inhibitor
    Patent 7,754,731
    Issued: July 13, 2010
    Inventor(s): Belyk; Kevin M. & Morrison; Henry G. & Mahajan; Amar J. & Kumke; Daniel J. & Tung; Hsien-Hsin & Wai; Lawrence & Pruzinsky; Vanessa
    Assignee(s): Merck Sharp & Dohme Corp.

    Potassium salts of Compound A and methods for their preparation are disclosed, wherein Compound A is of formula: Compound A is an HIV integrase inhibitor useful for treating or prophylaxis of HIV infection, for delaying the onset of AIDS, and for treating or prophylaxis of AIDS.

    Patent expiration dates:

    • March 11, 2029
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 11, 2029
      ✓ 
      Pediatric exclusivity

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.

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