Generic Ameluz Availability
Last updated on May 7, 2025.
Ameluz is a brand name of aminolevulinic acid topical, approved by the FDA in the following formulation(s):
AMELUZ (aminolevulinic acid hydrochloride - gel;topical)
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Manufacturer: BIOFRONTERA
Approval date: May 10, 2016
Strength(s): 10% [RLD]
Is there a generic version of Ameluz available?
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: 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.
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Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device
Patent 11,235,169
Issued: February 1, 2022
Inventor(s): Osterloh Markus & Novak Ben & Lübbert Hermann
Assignee(s): BIOFRONTERA PHARMA GMBHAn Illumination device () for photodynamic therapy is provided, the illumination device comprising at least one electromagnetic radiation emitting unit (), the at least one electromagnetic radiation emitting unit comprising at least one electromagnetic radiation source (), the electromagnetic radiation source being configured to generate radiation for the irradiation of a region of an irradiation object in an illumination session, wherein the irradiation object is to be arranged at a predetermined object location (), wherein the predetermined object location is arranged at a distance relative to a radiation output area () of the radiation emitting unit through which the radiation generated by the at least one electromagnetic radiation source exits the radiation emitting unit during operation of the illumination device ().
Patent expiration dates:
- October 15, 2040✓
- October 15, 2040
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Nanoemulsion formulation with improved stability and cell penetration
Patent 11,540,981
Issued: January 3, 2023
Inventor(s): Foguet Roca; Montserrat
Assignee(s): BIOFRONTERA BIOSCIENCE GMBH (Leverkusen, DE)The present invention relates to a nanoemulsion comprising at least one aqueous component and a carrier, wherein the carrier comprises at least one lipophilic component, at least one surfactant and at least one alcohol. The present invention further relates to a composition comprising said nanoemulsion and an active agent. In particular, the composition is present as a gel and the active agent is 5-aminolevulinic acid, a derivative, precursor and/or metabolite thereof. The invention further relates to the preparation of said nanoemulsion and/or composition and to their use for the treatment of dermatological diseases, virus-associated diseases as well as diseases associated with cell proliferation, in particular, tumor diseases and/or psoriasis. The present invention is further directed to the use of said nanoemulsion in cosmetics.
Patent expiration dates:
- February 7, 2028✓
- February 7, 2028
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:
- October 4, 2027 - INCREASE IN THE APPROVED DOSAGE REGIMEN TO A MAXIMUM APPLICATION AREA OF 60 CM^2 IN TOTAL (CORRESPONDING TO THREE 2 GM TUBES)
More about Ameluz (aminolevulinic acid topical)
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- Drug class: topical photochemotherapeutics
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.