Generic Mirvaso Availability

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

MIRVASO (brimonidine tartrate - gel;topical)

  • Manufacturer: GALDERMA LABS LP
    Approval date: August 23, 2013
    Strength(s): EQ 0.33% BASE [RLD]

Has a generic version of Mirvaso been approved?

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

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

  • Compounds, formulations, and methods for treating or preventing rosacea
    Patent 7,439,241
    Issued: October 21, 2008
    Inventor(s): DeJovin; Jack A. & DeJovin; Isabelle Jean
    Assignee(s): Galderma Laboratories, Inc.
    In methods, compounds, and topical formulations for treatment of rosacea incorporating compounds represented by the formulas below: wherein each of R1, R2, and R3 is independently hydrogen, hologen, alkyl, or alkoxy; each of R4 and R5 is independently hydrogen, alkyl, or alkoxy; and each of R6 and R7 is independently hydrogen, nitro, alkyl, or alkoxy; wherein each of A1, A3, and A4 is independently hydrogen or alkyl; and A2 is independently hydrogen or hydroxy; and wherein each of B1, B2, and B3 is independently hydrogen, hydroxy, or alkoxy; and each of B4 and B5 is independently hydrogen or alkyl, applying such compounds topically as sprays, mists, aerosols, solutions, lotions, gels, creams, ointments, pastes, unguents, emulsions, and suspensions to treat rosacea and its symptoms.
    Patent expiration dates:
    • August 25, 2025
      ✓ 
      Patent use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
  • Brimonidine gel composition
    Patent 8,053,427
    Issued: November 8, 2011
    Inventor(s): Buge; Jean-Christophe & Nadau-Fourcade; Karine & Meunier; Cyril
    Assignee(s): Galderma R&D SNC
    Improved topical gel compositions, such as those containing brimonidine, for the treatment of skin disorders are described. The gel compositions contain carbomer and methylparaben, and are substantially free of methylparaben crystalline particles after an extended period of storage.
    Patent expiration dates:
    • June 13, 2031
      ✓ 
      Patent use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
      ✓ 
      Drug product
  • Gel compositions and methods of use
    Patent 8,163,725
    Issued: April 24, 2012
    Inventor(s): Buge; Jean-Christophe & Nadau-Fourcade; Karine & Meunier; Cyril
    Assignee(s): Galderma R&D SNC
    Improved topical gel compositions for the treatment of skin disorders are described. The gel compositions contain carbomer and methylparaben, and are substantially free of methylparaben crystalline particles after an extended period of storage.
    Patent expiration dates:
    • June 13, 2031
      ✓ 
      Drug product
  • Compounds, formulations, and methods for ameliorating telangiectasis
    Patent 8,231,885
    Issued: July 31, 2012
    Inventor(s): DeJovin; Jack A. & DeJovin; Isabelle Jean
    Assignee(s): Galderma Laboratories Inc.
    Methods, compounds, and topical formulations for treatment of telangiectasias are disclosed. The methods comprise topically applying a composition comprising an α-adrenergic receptor agonist to telangiectatic skin. Amelioration of telangiectasia symptoms begins within minutes after topical application of a disclosed composition. A single application can significantly lessen telangiectasia discoloration for at least about 2 hours.
    Patent expiration dates:
    • May 24, 2025
      ✓ 
      Drug product
  • Methods and compositions for treating or preventing erythema
    Patent 8,410,102
    Issued: April 2, 2013
    Assignee(s): Galderma Laboratories Inc.
    Methods and products for treating or preventing erythema or a symptom associated with erythema in a subject are described. The methods involve topically applying to an affected skin area a topical aqueous gel composition comprising about 0.01% to about 10% by weight of at least one α-adrenergic receptor agonist and a pharmaceutically acceptable carrier.
    Patent expiration dates:
    • May 24, 2025
      ✓ 
      Patent use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
  • Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
    Patent 8,426,410
    Issued: April 23, 2013
    Assignee(s): Galderma Laboratories, Inc.
    In methods, compounds, and topical formulations for treatment of inflammatory skin disorders incorporating compounds represented by the formulas below: wherein each of R1, R2, and R3 is independently hydrogen, hologen, alkyl, or alkoxy; each of R4 and R5 is independently hydrogen, alkyl, or alkoxy; and each of R6 and R7 is independently hydrogen, nitro, alkyl, or alkoxy; wherein each of A1, A3, and A4 is independently hydrogen or alkyl; and A2 is independently hydrogen or hydroxy; and wherein each of B1, B2, and B3 is independently hydrogen, hydroxy, or alkoxy; and each of B4 and B5 is independently hydrogen or alkyl, applying such compounds topically as sprays, mists, aerosols, solutions, lotions, gels, creams, ointments, pastes, unguents, emulsions, and suspensions to treat inflammatory skin disorders and the symptoms associated therewith.
    Patent expiration dates:
    • May 24, 2025
      ✓ 
      Patent use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
  • Methods and compositions for safe and effective treatment of erythema
    Patent 8,513,247
    Issued: August 20, 2013
    Assignee(s): Galderma Laboratories, L.P.
    Improved methods and compositions for safe and effective treatment of erythema or a symptom associated with erythema in a subject are described. The methods involve topically applying to an affected skin area a topical composition comprising about 0.4% to about 0.6% by weight of brimonidine and a pharmaceutically acceptable carrier.
    Patent expiration dates:
    • March 25, 2031
      ✓ 
      Patent use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
      ✓ 
      Drug product
  • Methods and compositions for safe and effective treatment of erythema
    Patent 8,513,249
    Issued: August 20, 2013
    Assignee(s): Galderma Laboratories, L.P.
    Improved methods and compositions for safe and effective treatment of erythema or a symptom associated with erythema in a subject are described. The methods involve topically applying to an affected skin area a topical composition comprising about 0.4% to about 0.6% by weight of brimonidine and a pharmaceutically acceptable carrier.
    Patent expiration dates:
    • March 25, 2031
      ✓ 
      Patent use: TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
      ✓ 
      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:
    • August 23, 2016 -

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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