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Last Updated: July 22, 2024

Aminolevulinic acid hydrochloride - Generic Drug Details


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What are the generic sources for aminolevulinic acid hydrochloride and what is the scope of freedom to operate?

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:
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
Lee's Pharmaceutical LimitedPhase 3
National Heart, Lung, and Blood Institute (NHLBI)Phase 1/Phase 2
University of ZurichEarly Phase 1

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 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 ⤷  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 aminolevulinic acid hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 ⤷  Sign Up ⤷  Sign Up
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 ⤷  Sign Up ⤷  Sign Up
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 ⤷  Sign Up ⤷  Sign Up
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 ⤷  Sign Up ⤷  Sign Up
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for aminolevulinic acid hydrochloride

Country Patent Number Title Estimated Expiration
Japan 2023130447 光線力学的治療のための局所用組成物、閉塞性ドレッシング材、それを用いたキット、光線力学的治療用材料、および光線力学的治療のための方法 (TOPICAL COMPOSITION FOR PHOTODYNAMIC THERAPY, OBSTRUCTIVE DRESSING MATERIAL, KIT USING THE SAME, MATERIAL FOR PHOTODYNAMIC THERAPY, AND METHOD FOR PHOTODYNAMIC THERAPY) ⤷  Sign Up
Japan 5558827 ⤷  Sign Up
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) ⤷  Sign Up
South Korea 20230088755 광역학 요법용 조명 디바이스, 피부 질환 치료 방법 및 조명 디바이스 작동 방법 ⤷  Sign Up
Uruguay 30833 NANOEMULSION ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.