Details for New Drug Application (NDA): 208081
✉ Email this page to a colleague
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*:
Constraining patent/regulatory exclusivity:
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
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: | ⤷ Subscribe | 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: | ⤷ Subscribe | Patent Expiration: | Feb 7, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 208081
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Biofrontera | AMELUZ | aminolevulinic acid hydrochloride | GEL;TOPICAL | 208081-001 | May 10, 2016 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription