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Generic Zyclara Availability

Last updated on Sep 8, 2021.

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

ZYCLARA (imiquimod - cream;topical)

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

Has a generic version of Zyclara been approved?

A generic version of Zyclara has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Zyclara and have been approved by the FDA:

imiquimod cream;topical

  • Manufacturer: TARO
    Approval date: January 26, 2021
    Strength(s): 3.75% [AB]

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: 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.

  • 2×2×2 week dosing regimen for treating acting keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
    Patent 10,238,644
    Issued: March 26, 2019
    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
  • Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
    Patent 10,238,645
    Issued: March 26, 2019
    Assignee(s): Medicis Pharmaceutical Corporation

    Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-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 genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available for 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 genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter 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 genital/perianal warts are also disclosed and described.

    Patent expiration dates:

    • August 18, 2029
      ✓ 
      Patent use: TREATMENT OF GENITAL WARTS
    • August 18, 2029
      ✓ 
      Patent use: TREATMENT OF PERIANAL WARTS
  • Patent 10,918,635

    Patent expiration dates:

    • April 30, 2030
      ✓ 
      Patent use: TREATMENT OF GENITAL WARTS
    • April 30, 2030
      ✓ 
      Patent use: TREATMENT OF PERIANAL WARTS
  • 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 GENITAL WARTS
    • August 18, 2029
      ✓ 
      Patent use: TREATMENT OF PERIANAL WARTS

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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