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Last Updated: March 28, 2024

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

Aminolevulinic acid hydrochloride has thirty-six patent family members in eighteen countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aminolevulinic acid hydrochloride
Generic Entry Dates for aminolevulinic acid hydrochloride*:
Constraining patent/regulatory exclusivity:
OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY
Dosage:
FOR SOLUTION;ORAL
Generic Entry Dates for aminolevulinic acid hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;TOPICAL
Generic Entry Dates for aminolevulinic acid hydrochloride*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
National Heart, Lung, and Blood Institute (NHLBI)Phase 1/Phase 2
University of ZurichEarly Phase 1
photonamic GmbH & Co. KGPhase 1/Phase 2

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
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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

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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.