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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

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	13
Patent Applications:	271
Drug Prices:	Drug price information for AMELUZ
What excipients (inactive ingredients) are in AMELUZ?	AMELUZ excipients list
DailyMed Link:	AMELUZ at DailyMed

Drug patent expirations by year for AMELUZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AMELUZ

Generic Entry Date for AMELUZ^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208081 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

Sponsor	Phase
Case Comprehensive Cancer Center	Phase 2
The Cleveland Clinic	Phase 2
Biofrontera, Inc.	Phase 2

See all AMELUZ clinical trials

Pharmacology for AMELUZ

Drug Class	Optical Imaging Agent Porphyrin Precursor
Mechanism of Action	Fluorescence Contrast Activity

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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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

Expired US Patents for AMELUZ

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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
Patent: NANOEMULSION
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 07338323
Patent: Nanoemulsion
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0720853
Patent: NANOEMULSÃO
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 70715
Patent: NANOEMULSION (NANOEMULSION)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 07003730
Patent: Nanoemulsion que comprende a) componente acuoso y b) un vehiculo con i) 0,1-15% de un componente lipofilico, ii) un tensoactivo y iii) un alcohol c3-c5; composicion que la comprende opcionalmente con un agente activo; proceso de preparacion de la nanoemulsion y de la composicion; kit; y uso para diagnosticar enfermedades dermicas y proliferativas, y tratar enfermedades virales, dermicas y proliferativas.
Estimated Expiration: ⤷ Sign Up

China

Patent: 1588792
Patent: Nanoemulsion
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 38801
Patent: Nanoémulsion (Nanoemulsion)
Estimated Expiration: ⤷ Sign Up

Patent: 20872
Patent: NANOÉMULSION (NANOEMULSION)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 8934
Patent: ננו-תחליב (Nanoemulsion)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 58827
Estimated Expiration: ⤷ Sign Up

Patent: 10513363
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 09006088
Patent: NANOEMULSION. (NANOEMULSION.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 7061
Patent: NANOEMULSION
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 91917
Patent: НАНОЭМУЛЬСИЯ (NANOEMULSION)
Estimated Expiration: ⤷ Sign Up

Patent: 09128179
Patent: НАНОЭМУЛЬСИЯ
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0903468
Patent: NANOEMULSION
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 02107
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 1471
Patent: НАНОЕМУЛЬСІЇ[НАНОЭМУЛЬСИИ (NANOEMULSIONS)
Estimated Expiration: ⤷ Sign Up

Uruguay

Patent: 833
Patent: NANOEMULSION
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Canada	2670715	NANOEMULSION (NANOEMULSION)	⤷ Sign Up
South Africa	200104726	Nano-emulsion of 5-aminolevulinic acid.	⤷ Sign Up
European Patent Office	1128812	EMULSION NANOMETRIQUE D'ACIDE 5-AMINOLEVULINIQUE (NANO-EMULSION OF 5-AMINOLEVULINIC ACID)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008077641		⤷ Sign Up
Uruguay	30833	NANOEMULSION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration