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Last Updated: February 23, 2024

Aminolevulinic acid hydrochloride - Generic Drug Details


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What are the generic drug sources for aminolevulinic acid hydrochloride and what is the scope of patent protection?

Aminolevulinic acid hydrochloride is the generic ingredient in three branded drugs marketed by Nxdc, Biofrontera, and Dusa, and is included in three NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aminolevulinic acid hydrochloride has thirty-six patent family members in eighteen countries.

There are five drug master file entries for aminolevulinic acid hydrochloride. Three suppliers are listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aminolevulinic acid hydrochloride
Generic Entry Dates for aminolevulinic acid hydrochloride*:
Constraining patent/regulatory exclusivity:
OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY
Dosage:
FOR SOLUTION;ORAL
Generic Entry Dates for aminolevulinic acid hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;TOPICAL
Generic Entry Dates for aminolevulinic acid hydrochloride*:
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.

Recent Clinical Trials for aminolevulinic acid hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Heart, Lung, and Blood Institute (NHLBI)Phase 1/Phase 2
University of ZurichEarly Phase 1
Westfälische Wilhelms-Universität MünsterPhase 1/Phase 2

See all aminolevulinic acid hydrochloride clinical trials

Pharmacology for aminolevulinic acid hydrochloride
Medical Subject Heading (MeSH) Categories for aminolevulinic acid hydrochloride

US Patents and Regulatory Information for aminolevulinic acid hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 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
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nxdc GLEOLAN aminolevulinic acid hydrochloride FOR SOLUTION;ORAL 208630-001 Jun 6, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 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 ⤷  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

Expired US Patents for aminolevulinic acid hydrochloride

International Patents for aminolevulinic acid hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 4228745 DISPOSITIF D'ÉCLAIRAGE POUR THÉRAPIE PHOTODYNAMIQUE, MÉTHODE DE TRAITEMENT DE MALADIE DE LA PEAU ET MÉTHODE D'UTILISATION DE DISPOSITIF D'ÉCLAIRAGE (ILLUMINATION DEVICE FOR PHOTODYNAMIC THERAPY, METHOD FOR TREATING A SKIN DISEASE AND METHOD FOR OPERATING AN ILLUMINATION DEVICE) ⤷  Try a Trial
Canada 3195112 DISPOSITIF D'ECLAIRAGE POUR THERAPIE PHOTODYNAMIQUE, METHODE DE TRAITEMENT DE MALADIE DE LA PEAU ET METHODE D'UTILISATION DE DISPOSITIF D'ECLAIRAGE (ILLUMINATION DEVICE FOR PHOTODYNAMIC THERAPY, METHOD FOR TREATING A SKIN DISEASE AND METHOD FOR OPERATING AN ILLUMINATION DEVICE) ⤷  Try a Trial
Chile 2007003730 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. ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2022078955 ⤷  Try a Trial
South Korea 20230088755 광역학 요법용 조명 디바이스, 피부 질환 치료 방법 및 조명 디바이스 작동 방법 ⤷  Try a Trial
Japan 2010513363 ⤷  Try a Trial
Russian Federation 2009128179 НАНОЭМУЛЬСИЯ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Dow
Colorcon
McKinsey
Express Scripts
AstraZeneca

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