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Generic Picato Availability

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

PICATO (ingenol mebutate - gel;topical)

  • Manufacturer: LEO LABS
    Approval date: January 23, 2012
    Strength(s): 0.015% [RLD] [AB], 0.05% [RLD] [AB]

Has a generic version of Picato been approved?

A generic version of Picato 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 Picato and have been approved by the FDA:

ingenol mebutate gel;topical

  • Manufacturer: PERRIGO UK FINCO
    Approval date: January 7, 2019
    Strength(s): 0.015% [AB]
  • Manufacturer: PERRIGO UK FINCO
    Approval date: January 9, 2019
    Strength(s): 0.05% [AB]

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

  • Anti-cancer compounds
    Patent 7,410,656
    Issued: August 12, 2008
    Inventor(s): Aylward; James Harrison
    Assignee(s): Peplin Research Pty. Ltd.

    This invention relates to a compound or group of compounds present in an active principle derived from plants of species Euphorbia peplus, Euphorbia hirta and Euphorbia drummondii, and to pharmaceutical compositions comprising these compounds. Extracts from these plants have been found to show selective cytotoxicity against several different cancer cell lines. The compounds are useful in effective treatment of cancers, particularly malignant melanomas and squamous cell carcinomas (SCCs). In a preferred embodiment of the invention, the compound is selected from the group consisting of jatrophanes, pepluanes, paralianes and ingenanes, and pharmaceutically-acceptable salts or esters thereof, and more particularly jatrophanes of Conformation II.

    Patent expiration dates:

    • October 10, 2020
      ✓ 
      Patent use: TO INHIBIT THE PROLIFERATIVE ACTIVITY OF NEOPLASTIC CELLS
  • Therapeutic compositions
    Patent 8,278,292
    Issued: October 2, 2012
    Inventor(s): Brown; Marc Barry & Crowthers; Michael Edward Donald & Nazir; Tahir
    Assignee(s): LEO Laboroatories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • July 6, 2027
      ✓ 
      Drug product
  • Therapeutic compositions
    Patent 8,372,827
    Issued: February 12, 2013
    Assignee(s): LEO Laboratories Limted

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Drug product
  • Therapeutic compositions
    Patent 8,372,828
    Issued: February 12, 2013
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Drug product
  • Therapeutic compositions
    Patent 8,377,919
    Issued: February 19, 2013
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Drug product
  • Therapeutic compositions
    Patent 8,536,163
    Issued: September 17, 2013
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Patent use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
  • Therapeutic compositions
    Patent 8,716,271
    Issued: May 6, 2014
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Patent use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
  • Therapeutic compositions
    Patent 8,735,375
    Issued: May 27, 2014
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Patent use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
  • Method of topically treating actinic keratosis with ingenol mebutate cycle therapy
    Patent 9,789,078
    Issued: October 17, 2017
    Assignee(s): LEO Laboratories Limited

    The present invention relates to cyclic or repeated use of the ingenol mebutate for topical treatment of actinic keratosis lesions. Generally speaking, the present invention comprises a first ingenol mebutate treatment cycle and a second ingenol mebutate treatment cycle, wherein the first treatment cycle topically treats a treatment area with a topical gel formulated with ingenol mebutate at a selected dosage strength for a specified treatment regimen, and the second ingenol mebutate treatment cycle comprises topically re-treating the treatment area with the same topical ingenol mebutate gel for the same specified treatment regimen, if following the first treatment cycle, the treatment area failed to clear or failed to remain clear of AK lesions. The present invention further relates to spot or individual lesion therapy in the treatment area following the topical bi-cyclic therapy with ingenol mebutate.

    Patent expiration dates:

    • May 15, 2033
      ✓ 
      Patent use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP USING MORE THAN ONE TREATMENT COURSE OF INGENOL MEBUTATE
  • Therapeutic compositions
    Patent 9,820,959
    Issued: November 21, 2017
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Patent use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
      ✓ 
      Drug product
  • Therapeutic compositions
    Patent 9,833,428
    Issued: December 5, 2017
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Drug product
  • Therapeutic compositions
    Patent 9,833,429
    Issued: December 5, 2017
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Drug product
  • Therapeutic compositions
    Patent 9,861,603
    Issued: January 9, 2018
    Assignee(s): LEO Laboratories Limited

    Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.

    Patent expiration dates:

    • December 18, 2026
      ✓ 
      Patent use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Further information

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

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 (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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.
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