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 PHARMA AS
    Approval date: January 23, 2012
    Strength(s): 0.015%, 0.05% [RLD]

Has a generic version of Picato been approved?

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

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: 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.

  • Anti-cancer compounds
    Patent 6,432,452
    Issued: August 13, 2002
    Inventor(s): James Harrison; Aylward
    Assignee(s): Peplin Biotech Pty. Ltd.
    This invention relates to a compound or group of compounds present in an active principle derived from plants of the 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:
    • August 19, 2018
      ✓ 
      Patent use: TREATMENT OF ACTINIC KERATOSIS
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      Drug substance
  • Methods of stimulating the immune system
    Patent 6,844,013
    Issued: January 18, 2005
    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:
    • December 13, 2018
      ✓ 
      Patent use: TO STIMULATE THE IMMUNE SYSTEM TO INDUCE T CELL PROLIFERATION
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 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:
    • August 19, 2018
      ✓ 
      Patent use: TO INHIBIT THE PROLIFERATIVE ACTIVITY OF NEOPLASTIC CELLS
      ✓ 
      Drug substance
  • 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:
    • February 20, 2027
      ✓ 
      Drug substance
      ✓ 
      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 substance
      ✓ 
      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 substance
      ✓ 
      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 substance
      ✓ 
      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

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:
    • January 23, 2017 -

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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