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Generic Ameluz Availability

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

AMELUZ (aminolevulinic acid hydrochloride - gel;topical)

  • Manufacturer: BIOFRONTERA
    Approval date: May 10, 2016
    Strength(s): 10% [RLD]

Has a generic version of Ameluz been approved?

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

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

  • Nano-emulsion of 5-aminolevulinic acid
    Patent 6,559,183
    Issued: May 6, 2003
    Inventor(s): Hans W.; Schmid & Gerd; Burmeister
    Assignee(s): ASAT AG Applied Science & Technology
    The present invention relates to a composition comprising a nano-emulsion that contains 5-aminolevulinic acid as well as a carrier in an aqueous phase. This invention also relates to a pharmaceutical preparation containing this composition. The nano-emulsions of this type can be used in photodynamic therapy as well as in the photodiagnostic detection of proliferatives cells.
    Patent expiration dates:
    • November 12, 2019
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      Patent use: TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY
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      Drug product

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:
    • May 10, 2019 - NEW PRODUCT

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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