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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]
  • Manufacturer: ALLERGAN
    Approval date: October 27, 2016
    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.

  • Dispensing device
    Patent 8,292,129
    Issued: October 23, 2012
    Inventor(s): Stadelhofer; Peter & Greiner-Perth; Juergen
    Assignee(s): Ing. Erich Pfeiffer GmbH
    A dispensing device for liquid media having a housing, a medium reservoir, an outlet opening for dispensing the medium and an inlet opening for intake of air for the purpose of volume equalization in the medium reservoir, wherein a cap is provided that is fittable onto the housing and protects the outlet opening when in the fitted state. The cap closes the inlet opening in gas-tight manner from an environment on the one hand and from the outlet opening on the other hand.
    Patent expiration dates:
    • February 25, 2031
      ✓ 
      Drug product
  • Dispensing device
    Patent 8,561,859
    Issued: October 22, 2013
    Assignee(s): Aptar Radolfzell GmbH
    A dispensing device for dispensing liquid media having a housing, an outlet opening for the medium, a medium reservoir for storage of the medium and a conveying device for transporting the medium from the medium reservoir to the outlet opening, wherein a flow brake is provided in a medium duct between the conveying device and the outlet opening. The flow brake has a first flow brake component which can be arranged and fixed relative to the housing or to a second flow brake component during assembly in several differing relative positions, wherein differing flow resistances of the flow brake are achieved depending on the selected relative positions.
    Patent expiration dates:
    • April 16, 2032
      ✓ 
      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
  • Methods of providing therapeutic effects using cyclosporin components
    Patent 9,248,191
    Issued: February 2, 2016
    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).
  • Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
    Patent 9,669,974
    Issued: June 6, 2017
    Assignee(s): APTAR RADOLFZELL GMBH
    The invention relates to a protective cap for a dispenser, and to a dispenser for discharging pharmaceutical and/or cosmetical liquids, wherein the dispenser has a liquid reservoir and an outlet opening through which the liquid can be discharged into a surrounding atmosphere. The protective cap comprises an outer cap and an inner element inserted therein, wherein either at least one ventilation channel, which can be closed by means of a shut-off element and provides communication between an interior of the protective cap and an external environment, is formed between the outer cap and the inner element, or the inner element closes a ventilation opening of the outer cap.
    Patent expiration dates:
    • May 11, 2034
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      Drug product
  • Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
    Patent 9,676,525
    Issued: June 13, 2017
    Assignee(s): APTAR RADOLFZELL GMBH
    A protective cap for a dispenser for discharging liquids, wherein the dispenser has a liquid reservoir and an outlet opening through which the liquid is discharged into a surrounding atmosphere. The protective cap has an inner cap and an outer cap, the inner cap having a ventilation opening for communication between an interior of the protective cap and an external environment. Before use, the outer cap is mounted on the inner cap in a first position with the inner cap and the outer cap in sealing contact with each other and the ventilation opening is separated in an airtight and germproof manner from the environment, and the outer cap is movable relative to the inner cap from the first position to a second position in which the inner and outer caps are out of sealing contact with each other and the ventilation opening communicates with the environment.
    Patent expiration dates:
    • February 7, 2034
      ✓ 
      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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