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Generic Qutenza Availability

Last updated on July 7, 2021.

Qutenza is a brand name of capsaicin topical, approved by the FDA in the following formulation(s):

QUTENZA (capsaicin - patch;topical)

  • Manufacturer: AVERITAS
    Approval date: November 16, 2009
    Strength(s): 8% [RLD]

Has a generic version of Qutenza been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Qutenza. 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: Generic Drug FAQ.

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.

  • Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer
    Patent 10,034,841
    Issued: July 31, 2018
    Assignee(s): LTS Lohmann Therapie-Systeme AG

    The invention generally relates to a transdermal therapeutic system which comprises a backing layer, an adhesive layer, a polymer layer and a removable protective layer. The adhesive layer is an organosiloxane layer that is anchored to the backing layer by siliconization.

    Patent expiration dates:

    • September 6, 2025
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      Drug product
  • Patent 10,463,598

    Patent expiration dates:

    • September 5, 2023
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      Drug product
  • Transdermal therapeutic device and method with capsaicin and capsaicin analogs
    Patent 6,239,180
    Issued: May 29, 2001
    Inventor(s): Robbins; Wendye R.
    Assignee(s): The Regents of the University of California

    Transdermal application of capsaicin (or a capsaicin analog) in a concentration from greater than about 5% to about 10% by weight has been discovered to be an extremely effective therapy for treating neuropathic pain, so long as an anesthetic, preferably by means of a transdermal patch, is administered initially to the affected area to minimize the expected side effects from subsequent capsaicin application.

    Patent expiration dates:

    • June 4, 2021
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      Drug product
  • Compositions and kits for the removal of irritating compounds from bodily surfaces
    Patent 8,263,059
    Issued: September 11, 2012
    Inventor(s): Angel; Arturo J. & Litle; Larry W. & Bley; Keith R. & Wilcox; Allan L. & Jamieson; Gene Curtis & Muhammad; Naweed
    Assignee(s): NeurogesX, Inc.

    The invention provides compositions, methods and kits for the removal of harmful or irritating substances from bodily surfaces. Kits may include a composition containing capsaicin and a capsaicin-cleansing composition, e.g., a composition in which capsaicin is soluble.

    Patent expiration dates:

    • September 5, 2023
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      Patent use: METHOD OF USING CAPSAICIN IN COMBINATION WITH A GEL COMPOSITION FOR REMOVAL OF CAPSAICIN FROM A TREATMENT AREA OR UNINTENDED AREA
  • Therapeutic patch for transdermal delivery of capsaicin
    Patent 8,821,920
    Issued: September 2, 2014
    Assignee(s): LTS Lohmann Therapie Systeme AG

    The invention relates to a topical patch comprising a therapeutic compound-impermeable backing layer, a self-adhesive matrix based on polysiloxanes and containing capsaicin or a therapeutic compound analogous to capsaicin, and a protective film to be removed before use, in which the matrix contains liquid microreservoirs based on an amphiphilic solvent, in which the therapeutic compound is present in completely dissolved form and the concentration of the therapeutic compound in the microreservoir droplets is below the saturation concentration. The invention furthermore relates to a process for its production and its use in the treatment of neuropathic pain.

    Patent expiration dates:

    • March 26, 2030
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      Drug product
  • Compositions and kits for the removal of irritating compounds from bodily surfaces
    Patent 8,889,113
    Issued: November 18, 2014
    Assignee(s): Acorda Therapeutics, Inc.

    The invention provides compositions, methods and kits for the removal of harmful or irritating substances from bodily surfaces. Kits may include a composition containing capsaicin and a capsaicin-cleansing composition, e.g., a composition in which capsaicin is soluble.

    Patent expiration dates:

    • September 5, 2023
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      Patent use: METHOD OF USING CAPSAICIN IN COMBINATION WITH A GEL COMPOSITION FOR REMOVAL OF CAPSAICIN FROM A TREATMENT AREA OR UNINTENDED AREA
  • Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer
    Patent 9,226,903
    Issued: January 5, 2016
    Assignee(s): LTS Lohmann Therapie-Systeme AG

    The invention relates to a transdermal therapeutic system which comprises a backing layer, an adhesive layer, a polymer layer and a removable protective layer. The adhesive layer is an organosiloxane layer and is anchored in the backing layer by siliconization.

    Patent expiration dates:

    • December 15, 2028
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      Drug product

Related Exclusivities

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:

    • July 17, 2023 - TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY (DPN) OF THE FEET

Glossary

Term Definition
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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.