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Ameluz is a drug marketed by Biofrontera and is included in one NDA. There is one patent protecting this drug.
This drug has one patent family member in one country.
The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aminolevulinic acid hydrochloride profile page.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 15, 2040. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for AMELUZ
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||80|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for AMELUZ|
|What excipients (inactive ingredients) are in AMELUZ?||AMELUZ excipients list|
|DailyMed Link:||AMELUZ at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for AMELUZ
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for AMELUZ
Identify potential brand extensions & 505(b)(2) entrants
|Dartmouth-Hitchcock Medical Center||Early Phase 1|
|Jeffrey B. Travers, MD, PhD||Early Phase 1|
|Royal Cornwall Hospitals Trust||Phase 4|
Pharmacology for AMELUZ
|Drug Class||Porphyrin Precursor |
AMELUZ is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AMELUZ is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting AMELUZ
Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL LESION-DIRECTED AND FIELD-DIRECTED TREATMENT OF ACTINIC KERATOSIS OF THE FACE AND SCALP WITH PHOTODYNAMIC THERAPY BY POSITIONING AN ILLUMINATION DEVICE IN AN APPROPRIATE DISTANCE AND ILLUMINATING THE TREATMENT AREA WITH NARROWBAND RED LIGHT
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Biofrontera||AMELUZ||aminolevulinic acid hydrochloride||GEL;TOPICAL||208081-001||May 10, 2016||RX||Yes||Yes||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Biofrontera||AMELUZ||aminolevulinic acid hydrochloride||GEL;TOPICAL||208081-001||May 10, 2016||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
See the table below for patents covering AMELUZ around the world.
|Country||Patent Number||Title||Estimated Expiration|
|European Patent Office||1128812||EMULSION NANOMETRIQUE D'ACIDE 5-AMINOLEVULINIQUE (NANO-EMULSION OF 5-AMINOLEVULINIC ACID)||See Plans and Pricing|
|World Intellectual Property Organization (WIPO)||2022078955||See Plans and Pricing|
|Australia||1271000||See Plans and Pricing|
|Japan||2002529495||See Plans and Pricing|
|Australia||758098||See Plans and Pricing|
|World Intellectual Property Organization (WIPO)||0028971||See Plans and Pricing|
|South Africa||200104726||Nano-emulsion of 5-aminolevulinic acid.||See Plans and Pricing|
|>Country||>Patent Number||>Title||>Estimated Expiration|