Generic Invirase Availability
INVIRASE (saquinavir mesylate - capsule;oral)
Manufacturer: HOFFMANN LA ROCHE
Approval date: December 6, 1995
Strength(s): EQ 200MG BASE [RLD]
INVIRASE (saquinavir mesylate - tablet;oral)
Manufacturer: HOFFMAN LA ROCHE
Approval date: December 17, 2004
Strength(s): EQ 500MG BASE [RLD]
Has a generic version of Invirase been approved?
No. There is currently no therapeutically equivalent version of Invirase available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Invirase. 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.
There are no current U.S. patents associated with Invirase.
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:
- November 30, 2015 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
- May 30, 2016 -
- Invirase Consumer Information (Drugs.com)
- Invirase Consumer Information (Wolters Kluwer)
- Invirase capsules Consumer Information (Wolters Kluwer)
- Invirase Consumer Information (Cerner Multum)
- Invirase Advanced Consumer Information (Micromedex®)
- Invirase AHFS DI Monographs (ASHP)
- Saquinavir Consumer Information (Wolters Kluwer)
- Saquinavir capsules Consumer Information (Wolters Kluwer)
- Saquinavir mesylate Consumer Information (Wolters Kluwer)
- Saquinavir Consumer Information (Cerner Multum)
- Saquinavir Advanced Consumer Information (Micromedex®)
- Saquinavir AHFS DI Monographs (ASHP)
|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.|