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

Aminolevulinic acid hydrochloride has six patent family members in three countries.

There are six drug master file entries for aminolevulinic acid hydrochloride. Two suppliers are listed for this compound.

Summary for aminolevulinic acid hydrochloride

International Patents:	6
US Patents:	2
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	88
Patent Applications:	308
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
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	N/A
SBI ALApharma Canada, Inc.	Phase 3
Westfälische Wilhelms-Universität Münster	Phase 2

See all aminolevulinic acid hydrochloride clinical trials

Pharmacology for aminolevulinic acid hydrochloride

Drug Class

Porphyrin Precursor

Medical Subject Heading (MeSH) Categories for aminolevulinic acid hydrochloride

Photosensitizing Agents

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
Nxdc	GLEOLAN	aminolevulinic acid hydrochloride	FOR SOLUTION;ORAL	208630-001	Jun 6, 2017		RX	Yes	Yes
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016		RX	Yes	Yes

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
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999
Dusa	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999

International Patents for aminolevulinic acid hydrochloride

Country	Patent Number	Estimated Expiration
Japan	2019123708
Australia	2019200152
Australia	2020267186
Canada	3029792
Australia	2021102111
Australia	2020103365