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Last Updated: January 27, 2023

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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aminolevulinic acid hydrochloride has nine patent family members in four countries.

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

Recent Clinical Trials for aminolevulinic acid hydrochloride

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

SponsorPhase
Westfälische Wilhelms-Universität MünsterPhase 1/Phase 2
photonamic GmbH & Co. KGPhase 1/Phase 2
Alpheus Medical, Inc.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
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nxdc GLEOLAN aminolevulinic acid hydrochloride FOR SOLUTION;ORAL 208630-001 Jun 6, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Japan 2019123708 光線力学療法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、光線力学療法材料、および光線力学療法のための方法 (TOPICAL COMPOSITION FOR PHOTODYNAMIC THERAPY, OCCLUSIVE DRESSING MATERIAL, KIT USING THE SAME, PHOTODYNAMIC THERAPY MATERIAL, AND METHOD FOR PHOTODYNAMIC THERAPY) See Plans and Pricing
Australia 2021102111 Methods for photodynamic therapy See Plans and Pricing
Australia 2020103365 Methods for photodynamic therapy See Plans and Pricing
Australia 2020267186 Methods for photodynamic therapy See Plans and Pricing
Canada 3029792 METHODES DE THERAPIE PHOTODYNAMIQUE (METHODS FOR PHOTODYNAMIC THERAPY) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2022078955 See Plans and Pricing
Australia 2019200152 Methods for photodynamic therapy See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Dow
Colorcon
McKinsey
Express Scripts
AstraZeneca

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.