Medication Guide App

Generic Isentress Availability

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

ISENTRESS (raltegravir potassium - powder;oral)

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

ISENTRESS (raltegravir potassium - tablet, chewable;oral)

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

ISENTRESS (raltegravir potassium - tablet;oral)

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: About generic drugs.

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
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  • 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:
    • October 21, 2022
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      Patent use: TREATMENT OF HIV INFECTION
  • 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:
    • October 21, 2022
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      Patent use: TREATMENT OF HIV INFECTION
    • October 21, 2022
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      Patent use: INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION
  • 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
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      Patent use: TREATMENT OF HIV INFECTION
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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 21, 2014 -
    • December 21, 2014 -
    • March 28, 2015 - CHANGES IN SECTION 14 OF THE PACKAGE INSERT TO INCLUDE DATA FROM THE SWITCHMRK STUDIES (SWITCH OF SUPPRESSED SUBJECTS FROM LOPINAVIR/RITONAVIR TO RALTEGRAVIR)
    • December 20, 2016 -

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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