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Generic Subsys Availability

Subsys is a brand name of fentanyl, approved by the FDA in the following formulation(s):

SUBSYS (fentanyl - spray;sublingual)

  • Manufacturer: INSYS THERAP
    Approval date: January 4, 2012
    Strength(s): 0.8MG, 0.1MG, 0.2MG, 0.4MG [RLD], 0.6MG
  • Manufacturer: INSYS THERAP
    Approval date: August 30, 2012
    Strength(s): 1.2MG, 1.6MG

Has a generic version of Subsys been approved?

No. There is currently no therapeutically equivalent version of Subsys available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Subsys. 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.

  • Sublingual fentanyl spray
    Patent 8,486,972
    Issued: July 16, 2013
    Assignee(s): Insys Therapeutics, Inc.
    The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
    Patent expiration dates:
    • April 27, 2030
      ✓ 
      Drug product
  • Sublingual fentanyl spray
    Patent 8,486,973
    Issued: July 16, 2013
    Assignee(s): Insys Therapeutics, Inc.
    The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
    Patent expiration dates:
    • April 27, 2030
      ✓ 
      Patent use: TREATMENT OF PAIN
  • Sublingual fentanyl spray
    Patent 8,835,459
    Issued: September 16, 2014
    Assignee(s): Insys Therapeutics, Inc.
    The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
    Patent expiration dates:
    • January 25, 2027
      ✓ 
      Drug product
  • Sublingual fentanyl spray and methods of treating pain
    Patent 8,835,460
    Issued: September 16, 2014
    Assignee(s): Insys Therapeutics, Inc.
    The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
    Patent expiration dates:
    • January 25, 2027
      ✓ 
      Patent use: TREATMENT OF PAIN
      ✓ 
      Drug product
  • Sublingual fentanyl spray
    Patent 9,241,935
    Issued: January 26, 2016
    Assignee(s): Insys Pharma, Inc.
    The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
    Patent expiration dates:
    • January 25, 2027
      ✓ 
      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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