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.

Summary for aminolevulinic acid hydrochloride

International Patents:	9
US Patents:	4
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	96
Patent Applications:	5,714
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aminolevulinic acid hydrochloride
What excipients (inactive ingredients) are in aminolevulinic acid hydrochloride?	aminolevulinic acid hydrochloride excipients list
DailyMed Link:	aminolevulinic acid hydrochloride at DailyMed

Recent Clinical Trials for aminolevulinic acid hydrochloride

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

Sponsor	Phase
Westfälische Wilhelms-Universität Münster	Phase 1/Phase 2
photonamic GmbH & Co. KG	Phase 1/Phase 2
Alpheus Medical, Inc.	Phase 1

See all aminolevulinic acid hydrochloride clinical trials

Pharmacology for aminolevulinic acid hydrochloride

Drug Class	Optical Imaging Agent Porphyrin Precursor
Mechanism of Action	Fluorescence Contrast Activity

Medical Subject Heading (MeSH) Categories for aminolevulinic acid hydrochloride

Photosensitizing Agents

US Patents and Regulatory Information for aminolevulinic acid hydrochloride

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Glossary

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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

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

International Patents for aminolevulinic acid hydrochloride

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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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