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Generic Levulan Kerastick Availability

Levulan Kerastick is a brand name of aminolevulinic acid topical, approved by the FDA in the following formulation(s):

LEVULAN (aminolevulinic acid hydrochloride - solution;topical)

  • Manufacturer: DUSA
    Approval date: December 3, 1999
    Strength(s): 20% [RLD]

Has a generic version of Levulan Kerastick been approved?

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

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

  • Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light
    Patent 6,709,446
    Issued: March 23, 2004
    Inventor(s): Scott; Lundahl & Rebecca; Kozodoy & Ronald; Carroll & Elton; Leppelmeier
    Assignee(s): Dusa Pharmaceuticals, Inc.

    An apparatus and method for photodynamic therapy or photodynamic diagnosis using an illuminator comprising a plurality of light sources generally conforming to a contoured surface and irradiating the contoured surface with substantially uniform intensity visible light. The light sources may comprise generally U-shaped fluorescent tubes that are driven by electronic ballasts. Adjustment of the ballast voltage controls the output power of the tubes. The tubes are supported by a sheet-metal or plastic housing and are covered by a polycarbonate shield which directs cooling airflow within the unit and prevents glass-patient contact in the event of tube breakage. An aluminum reflector located behind the tubes increases both the output irradiance and the uniformity of the output distribution. The spacing of the U-shaped tubes is varied to increase the output at the edges of the illuminator to make the output more uniform. Also, different portions of the tubes are cooled at different amounts, to improve uniformity. A light sensor monitors output from the U-shaped tubes to provide a signal for adjusting the output from the tubes.

    Patent expiration dates:

    • May 1, 2018
      ✓ 
      Patent use: TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
  • Method of photodynamically diagnosing or treating a contoured surface
    Patent 7,723,910
    Issued: May 25, 2010
    Inventor(s): Lundahl; Scott & Kozodoy; Rebecca & Carroll; Ronald & Leppelmeier; Elton
    Assignee(s): DUSA Pharmaceuticals, Inc.

    A method of photodynamically diagnosing or treating a contoured surface includes topically applying 5-aminolevulinic acid to the contoured surface and irradiating the contoured surface with substantially uniform intensity visible light from a plurality of light sources generally conforming to the contoured surface. The plurality of light sources may comprise fluorescent tubes.

    Patent expiration dates:

    • June 17, 2019
      ✓ 
      Patent use: TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
  • Illuminator for photodynamic therapy
    Patent 8,216,289
    Issued: July 10, 2012
    Inventor(s): Lundahl; Scott & Kozodoy; Rebecca & Carroll; Ronald & Leppelmeier; Elton
    Assignee(s): Dusa Pharmaceuticals, Inc.

    An apparatus and method for photodynamic therapy or photodynamic diagnosis using an illuminator comprising a plurality of light sources generally conforming to a contoured surface and irradiating the contoured surface with substantially uniform intensity visible light. The light sources may comprise generally U-shaped fluorescent tubes that are driven by electronic ballasts. Adjustment of the ballast voltage controls the output power of the tubes. The tubes are supported by a sheet-metal or plastic housing and are covered by a polycarbonate shield which directs cooling airflow within the unit and prevents glass-patient contact in the vent of tube breakage. An aluminum reflector located behind the tubes increases both the output irradiance and the uniformity of the output distribution. The spacing of the U-shaped tubes is varied to increase the output at the edges of the illuminator to make the output more uniform. Also, different portions of the tubes are cooled at different amounts, to improve uniformity. A light sensor monitors output from the U-shaped tubes to provide a signal for adjusting the output from the tubes.

    Patent expiration dates:

    • May 1, 2018
      ✓ 
      Patent use: TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
  • Illuminator for photodynamic therapy
    Patent 8,758,418
    Issued: June 24, 2014
    Assignee(s): Dusa Pharmaceuticals, Inc.

    An apparatus and method for photodynamic therapy or photodynamic diagnosis using an illuminator comprising a plurality of light sources generally conforming to a contoured surface and irradiating the contoured surface with substantially uniform intensity visible light. The light sources may comprise generally U-shaped fluorescent tubes that are driven by electronic ballasts. The spacing of the U-shaped tubes is varied to increase the output at the edges of the illuminator to make the output more uniform. Also, different portions of the tubes are cooled at different amounts, to improve uniformity. A light sensor monitors output from the U-shaped tubes to provide a signal for adjusting the output from the tubes.

    Patent expiration dates:

    • May 1, 2018
      ✓ 
      Patent use: TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP

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 9, 2021 - TREATMENT OF MINIMALLY TO MODERATELY THICK ACTINIC KERATOSIS OF THE UPPER EXTREMITIES IN CONJUNCTION WITH A BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

Further information

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

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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