Generic Restasis Availability
RESTASIS (cyclosporine - emulsion;ophthalmic)
Has a generic version of Restasis been approved?
No. There is currently no therapeutically equivalent version of Restasis available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Restasis. 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.
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.
Nonirritating emulsions for sensitive tissue
Issued: December 12, 1995
Inventor(s): Ding; Shulin & Tien; Walter L. & Olejnik; Orest
Assignee(s): Allergan, Inc.
A pharmaceutical composition is disclosed in the form of a nonirritating emulsion which includes at least one cyclosporin in admixture with a higher fatty acid glyceride and polysorbate 80. More particularly, the cyclosporin may be cyclosporin A and the higher fatty acid glyceride may be castor oil. Composition has been found to be of a high comfort level and low irritation potential suitable for delivery of medications to sensitive areas such as ocular tissues. In addition, the composition has stability for up to nine months without crystallization of cyclosporin.Patent expiration dates:
- May 17, 2014✓
- May 17, 2014
- Restasis Consumer Information (Drugs.com)
- Restasis drops Consumer Information (Wolters Kluwer)
- Restasis Consumer Information (Cerner Multum)
- Restasis Advanced Consumer Information (Micromedex)
- Restasis eent AHFS DI Monographs (ASHP)
- Cyclosporine drops Consumer Information (Wolters Kluwer)
- Cyclosporine ophthalmic Consumer Information (Cerner Multum)
- Cyclosporine Ophthalmic Advanced Consumer Information (Micromedex)
- Cyclosporine eent 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.|