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-seven patent family members in eighteen 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:	37
US Patents:	7
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	100
Patent Applications:	6,457
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SOLUTION;TOPICAL
Generic Entry Dates for AMINOLEVULINIC ACID HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Lee's Pharmaceutical Limited	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1/Phase 2
University of Zurich	Early 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

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

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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
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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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

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Country	Patent Number	Title	Estimated Expiration
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
Mexico	2009006088	NANOEMULSION. (NANOEMULSION.)	⤷ Sign Up
China	116507387	用于光动力治疗的照明装置、用于治疗皮肤病的方法和用于操作照明装置的方法 (Lighting device for photodynamic therapy, method for treating skin diseases and method for operating lighting device)	⤷ Sign Up
Uruguay	30833	NANOEMULSION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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