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Generic Qbrexza Availability

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

QBREXZA (glycopyrronium tosylate - cloth;topical)

  • Manufacturer: DERMIRA INC
    Approval date: June 28, 2018
    Strength(s): EQ 2.4% BASE [RLD]

Has a generic version of Qbrexza been approved?

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

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

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.

  • Glycopyrrolate salts
    Patent 10,004,717
    Issued: June 26, 2018
    Assignee(s): DERMIRA, INC.

    Salts of glycopyrrolate, including solid forms and formulations such as topicals thereof, are disclosed. Methods of making glycopyrrolate salts, including formulations such as topicals thereof, and methods of treating hyperhidrosis with salts of glycopyrrolate, and formulations such as topicals thereof, are disclosed.

    Patent expiration dates:

    • February 28, 2033
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      Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
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      Drug product
  • Topical glycopyrrolate formulations
    Patent 10,052,267
    Issued: August 21, 2018
    Assignee(s): ROSE U, LLC

    Individually packaged topical formulations comprising about 0.25 to about 6% w/w of glycopyrrolate for the treatment of hyperhidrosis, wherein said wipe is contained within a pouch resistant to leakage. The formulations may further comprise ethanol, a buffering agent and water. In addition, the formulations may further comprise a polymer system comprising a hydrophobic polymer in combination with a hydrophilic polymer.

    Patent expiration dates:

    • October 17, 2028
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      Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
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      Drug product
  • Patent 10,543,192

    Patent expiration dates:

    • February 28, 2033
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      Drug product
  • Patent 10,548,875

    Patent expiration dates:

    • February 28, 2033
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      Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
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      Drug substance
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      Drug product
  • Topical glycopyrrolate formulations
    Patent 8,618,160
    Issued: December 31, 2013
    Assignee(s): Rose U

    Individually packaged topical formulations comprising about 0.25 to about 6% w/w of glycopyrrolate for the treatment of hyperhidrosis, wherein said wipe is contained within a pouch resistant to leakage. The formulations may further comprise ethanol, a buffering agent and water. In addition, the formulations may further comprise a polymer system comprising a hydrophobic polymer in combination with a hydrophilic polymer.

    Patent expiration dates:

    • December 10, 2029
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      Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
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      Drug product
  • Crystalline glycopyrrolate tosylate
    Patent 8,859,610
    Issued: October 14, 2014
    Assignee(s): Dermira, Inc.

    Salts of glycopyrrolate, including solid forms thereof are herein disclosed. Methods of making glycopyrrolate salts and methods of treating hyperhidrosis with salts of glycopyrrolate are disclosed.

    Patent expiration dates:

    • February 28, 2033
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      Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
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      Drug product
  • Glycopyrrolate salts
    Patent 9,259,414
    Issued: February 16, 2016
    Assignee(s): Dermira, Inc.

    Salts of glycopyrrolate, including solid forms and formulations such as topicals thereof, are disclosed. Methods of making glycopyrrolate salts, including formulations such as topicals thereof, and methods of treating hyperhidrosis with salts of glycopyrrolate, and formulations such as topicals thereof, are disclosed.

    Patent expiration dates:

    • February 28, 2033
      ✓ 
      Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
  • Topical glycopyrrolate formulations
    Patent 9,744,105
    Issued: August 29, 2017
    Assignee(s): ROSE U, LLC

    Individually packaged topical formulations comprising about 0.25 to about 6% w/w of glycopyrrolate for the treatment of hyperhidrosis, wherein said wipe is contained within a pouch resistant to leakage. The formulations may further comprise ethanol, a buffering agent and water. In addition, the formulations may further comprise a polymer system comprising a hydrophobic polymer in combination with a hydrophilic polymer.

    Patent expiration dates:

    • July 18, 2030
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      Patent use: TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
      ✓ 
      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:

    • June 28, 2021 - NEW PRODUCT

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.