Generic Zyclara Availability

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

ZYCLARA (imiquimod - cream;topical)

  • Manufacturer: MEDICIS
    Approval date: March 25, 2010
    Strength(s): 3.75% [RLD]
  • Manufacturer: MEDICIS
    Approval date: July 15, 2011
    Strength(s): 2.5% [RLD]

Has a generic version of Zyclara been approved?

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

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

  • 2×2×2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod
    Patent 8,222,270
    Issued: July 17, 2012
    Inventor(s): Nordsiek; Michael T. & Levy; Sharon F. & Lee; James H. & Kulp; James H. & Balaji; Kodumudi S. & Meng; Tze-Chiang & Wu; Jason J. & Bahm; Valyn S. & Babilon; Robert
    Assignee(s): Medicis Pharmaceutical Corporation
    Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available ALDARA 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for ALDARA 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
    Patent expiration dates:
    • December 11, 2029
      ✓ 
      Patent use: TREATMENT OF ACTINIC KERATOSIS
  • 2×2×2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod
    Patent 8,236,816
    Issued: August 7, 2012
    Inventor(s): Nordsiek; Michael T. & Levy; Sharon F. & Lee; James H. & Kulp; James H. & Balaji; Kodumudi S. & Meng; Tze-Chiang & Wu; Jason J. & Bahm; Valyn S. & Babilon; Robert
    Assignee(s): Medicis Pharmaceutical Corporation
    Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available ALDARA 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for ALDARA 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
    Patent expiration dates:
    • December 11, 2029
      ✓ 
      Patent use: TREATMENT OF ACTINIC KERATOSIS
  • Method of treating actinic keratosis with 3.75% imiquimod cream
    Patent 8,299,109
    Issued: October 30, 2012
    Inventor(s): Nordsiek; Michael T. & Levy; Sharon F. & Lee; James H. & Kulp; James H. & Balaji; Kodumudi S. & Meng; Tze-Chiang & Wu; Jason J. & Bahm; Valyn S. & Babilon; Robert
    Assignee(s): Medicis Pharmaceutical Corporation
    Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available ALDARA 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for ALDARA 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
    Patent expiration dates:
    • December 11, 2029
      ✓ 
      Patent use: TREATMENT OF ACTINIC KERATOSIS
  • Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
    Patent 8,598,196
    Issued: December 3, 2013
    Assignee(s): Medicis Pharmaceutical Corporation
    Pharmaceutical formulations and methods for the topical and/or transdermal delivery of imiquimod, including creams, ointments and pressure-sensitive adhesive compositions to treat dermatological disorders, namely, viral infections, such as Type I or Type II Herpes simplex infections and genital and perianal warts, actinic keratosis and superficial basal cell carcinoma, and to induce interferon biosynthesis to achieve an antiviral effect, with shorter durations of therapy, than currently approved for imiquimod by the Food & Drug Administration (“FDA”).
    Patent expiration dates:
    • August 18, 2029
      ✓ 
      Patent use: TREATMENT OF PERIANAL WARTS
    • August 18, 2029
      ✓ 
      Patent use: TREATMENT OF GENITAL WARTS

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:
    • March 24, 2014 - TREATMENT OF EXTERNAL GENITAL AND PERIANAL WARTS/CONDYLOMA ACUMINATA IN PATIENTS 12 YEARS OR OLDER
    • July 15, 2014 -

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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