Details for New Drug Application (NDA): 208081

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NDA 208081 describes AMELUZ, which is a drug marketed by Biofrontera and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the AMELUZ profile page.

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.

Summary for 208081

Tradename:	AMELUZ
Applicant:	Biofrontera
Ingredient:	aminolevulinic acid hydrochloride
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208081

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

Pharmacology for NDA: 208081

Mechanism of Action	Fluorescence Contrast Activity

Medical Subject Heading (MeSH) Categories for 208081

Photosensitizing Agents

Suppliers and Packaging for NDA: 208081

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081	NDA	Biofrontera Inc.	70621-101	70621-101-10	1 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01)
AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081	NDA	Biofrontera Inc.	70621-101	70621-101-20	10 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	10%
Approval Date:	May 10, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 15, 2040	Product Flag?		Substance Flag?		Delist Request?
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:	⤷ Sign Up	Patent Expiration:	Feb 7, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 208081

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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

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