Generic Isentress Availability
Last updated on Apr 10, 2025.
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)
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Manufacturer: MSD SUB MERCK
Approval date: December 20, 2013
Strength(s): EQ 100MG BASE/PACKET [RLD] [AB]
ISENTRESS (raltegravir potassium - tablet, chewable;oral)
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Manufacturer: MSD SUB MERCK
Approval date: December 21, 2011
Strength(s): EQ 25MG BASE [RLD] [AB], EQ 100MG BASE [RLD] [AB]
ISENTRESS (raltegravir potassium - tablet;oral)
Is there a generic version of Isentress available?
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.
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Potassium salt of an HIV integrase inhibitor
Patent 7,754,731
Issued: July 13, 2010
Inventor(s): Belyk; Kevin M. et al.
Assignee(s): Merck Sharp & Dohme Corp. (Rahway, NJ)Potassium salts of Compound A and methods for their preparation are disclosed, wherein Compound A is of formula: ##STR00001## 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✓✓✓
- March 11, 2029
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Potassium salt of an HIV integrase inhibitor
Patent 7754731*PED
Issued: July 13, 2010
Inventor(s): Belyk; Kevin M. et al.
Assignee(s): Merck Sharp & Dohme Corp. (Rahway, NJ)Potassium salts of Compound A and methods for their preparation are disclosed, wherein Compound A is of formula: ##STR00001## 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:
- September 11, 2029✓
- September 11, 2029
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Pharmaceutical composition containing an anti-nucleating agent
Patent 8,771,733
Issued: July 8, 2014
Inventor(s): Cruanes Maria T. & Xu Wei & Artino Laura M. & Zhu Honggang
Assignee(s): Merck Sharp & Dohme Corp.Pharmaceutical compositions suitable for oral administration in solid dosage forms are described. The compositions comprise an effective amount of a drug compound in the form of a salt, wherein the drug salt is characterized by conversion to a less soluble form of the drug compound under certain pH conditions, and an anti-nucleating agent.
Patent expiration dates:
- June 2, 2030✓✓✓
- June 2, 2030
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Pharmaceutical formulation containing a release rate controlling composition
Patent 8,852,632
Issued: October 7, 2014
Inventor(s): Pourkavoos Nazaneen & Ney James R. & Cruanes Maria T. & Wu Yunhui & Palkar Saurabh A.
Assignee(s): Merck Sharp & Dohme Corp.Pharmaceutical formulations suitable for oral administration in solid dosage forms are described. The compositions comprise an effective amount of a base salt of a compound of Formula (I) and a release rate controlling composition comprising a solubilizing agent, a gelling agent, and a water soluble filler; wherein R, R, Rand Rare defined herein. The formulations are suitable for use in the inhibition of HIV integrase, the treatment and prophylaxis of HIV infection, and the treatment, prophylaxis and delay in the onset of AIDS.
Patent expiration dates:
- January 28, 2028✓✓✓
- January 28, 2028
More about Isentress (raltegravir)
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- Drug class: integrase strand transfer inhibitor
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Glossary
Term | Definition |
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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. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.