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Last Updated: February 26, 2024

AMELUZ Drug Patent Profile


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Which patents cover Ameluz, and what generic alternatives are available?

Ameluz is a drug marketed by Biofrontera and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-six patent family members in eighteen countries.

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.

DrugPatentWatch® Generic Entry Outlook for Ameluz

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 7, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AMELUZ
Drug patent expirations by year for AMELUZ
Drug Prices for AMELUZ

See drug prices for AMELUZ

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMELUZ
Generic Entry Date for AMELUZ*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GEL;TOPICAL

*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

SponsorPhase
Dartmouth-Hitchcock Medical CenterEarly Phase 1
Jeffrey B. Travers, MD, PhDEarly Phase 1
Royal Cornwall Hospitals TrustPhase 4

See all AMELUZ clinical trials

Pharmacology for AMELUZ

US Patents and Regulatory Information for AMELUZ

AMELUZ is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AMELUZ is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for AMELUZ

When does loss-of-exclusivity occur for AMELUZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4659
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 07338323
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0720853
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 70715
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 07003730
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1588792
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 38801
Estimated Expiration: ⤷  Try a Trial

Patent: 20872
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8934
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 58827
Estimated Expiration: ⤷  Try a Trial

Patent: 10513363
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 09006088
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 7061
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 91917
Estimated Expiration: ⤷  Try a Trial

Patent: 09128179
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0903468
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 02107
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 1471
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 833
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AMELUZ around the world.

Country Patent Number Title Estimated Expiration
Israel 142876 ⤷  Try a Trial
Portugal 1128812 ⤷  Try a Trial
Japan 2023545490 光線力学的療法用の照明装置、皮膚疾患の治療方法、および照明装置の動作方法 ⤷  Try a Trial
Russian Federation 2491917 НАНОЭМУЛЬСИЯ (NANOEMULSION) ⤷  Try a Trial
Spain 2602107 ⤷  Try a Trial
Canada 2670715 NANOEMULSION (NANOEMULSION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Baxter
Boehringer Ingelheim
Dow
Harvard Business School

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