Last Updated: June 24, 2026

Aminolevulinic acid hydrochloride - Generic Drug Details

Name: aminolevulinic acid hydrochloride Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

✉ Email this page to a colleague

« Back to Dashboard

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 Sun Pharm Inds Inc, and is included in three NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aminolevulinic acid hydrochloride has sixty-one patent family members in nineteen countries.

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

Summary for aminolevulinic acid hydrochloride

International Patents:	61
US Patents:	13
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	110
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aminolevulinic acid hydrochloride

Generic Entry Dates for aminolevulinic acid hydrochloride^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 12,290,700 Dosage: SOLUTION;TOPICAL
Generic Entry Dates for aminolevulinic acid hydrochloride^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 12,280,146 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

Sponsor	Phase
University of Pittsburgh Medical Center	PHASE2
NX Development Corp	PHASE2
StacheStrong Foundation	PHASE2

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

Anatomical Therapeutic Chemical (ATC) Classes for aminolevulinic acid hydrochloride

L01XD	Sensitizers used in photodynamic/radiation therapy
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for aminolevulinic acid hydrochloride

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	11,077,192	⤷ Start Trial				⤷ Start Trial
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	11,179,574	⤷ Start Trial				⤷ Start Trial
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999		RX	Yes	Yes	10,357,567	⤷ Start Trial				⤷ Start 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

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	7,723,910	⤷ Start Trial
Sun Pharm Inds Inc	LEVULAN	aminolevulinic acid hydrochloride	SOLUTION;TOPICAL	020965-001	Dec 3, 1999	5,211,938	⤷ Start Trial
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081-001	May 10, 2016	6,559,183	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for aminolevulinic acid hydrochloride

Subscribe to access the full database, or Start Trial
Country	Patent Number	Title	Estimated Expiration
Australia	2019200152	Methods for photodynamic therapy	⤷ Start Trial
Australia	2020103365	Methods for photodynamic therapy	⤷ Start Trial
Australia	2020267186	Methods for photodynamic therapy	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.