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Generic Restasis Availability

Restasis is a brand name of cyclosporine ophthalmic, approved by the FDA in the following formulation(s):

RESTASIS (cyclosporine - emulsion;ophthalmic)

  • Manufacturer: ALLERGAN
    Approval date: December 23, 2002
    Strength(s): 0.05% [RLD]

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.

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.

  • Nonirritating emulsions for sensitive tissue
    Patent 5,474,979
    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
      ✓ 
      Drug product
  • Methods of providing therapeutic effects using cyclosporin components
    Patent 8,629,111
    Issued: January 14, 2014
    Assignee(s): Allergan, Inc.
    Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.
    Patent expiration dates:
    • August 27, 2024
      ✓ 
      Drug product
  • Methods of providing therapeutic effects using cyclosporin components
    Patent 8,633,162
    Issued: January 21, 2014
    Assignee(s): Allergan, Inc.
    Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1 % by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.
    Patent expiration dates:
    • August 27, 2024
      ✓ 
      Patent use: INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
  • Methods of providing therapeutic effects using cyclosporin components
    Patent 8,642,556
    Issued: February 4, 2014
    Assignee(s): Allergan, Inc.
    Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.
    Patent expiration dates:
    • August 27, 2024
      ✓ 
      Drug product
  • Methods of providing therapeutic effects using cyclosporin components
    Patent 8,648,048
    Issued: February 11, 2014
    Assignee(s): Allergan, Inc.
    Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.
    Patent expiration dates:
    • August 27, 2024
      ✓ 
      Patent use: INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
  • Methods of providing therapeutic effects using cyclosporin components
    Patent 8,685,930
    Issued: April 1, 2014
    Assignee(s): Allergan, Inc.
    Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.
    Patent expiration dates:
    • August 27, 2024
      ✓ 
      Drug product

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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