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Last Updated: October 24, 2021

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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.

Recent Clinical Trials for aminolevulinic acid hydrochloride

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

SponsorPhase
Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaN/A
SBI ALApharma Canada, Inc.Phase 3
Westfälische Wilhelms-Universität MünsterPhase 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
Nxdc GLEOLAN aminolevulinic acid hydrochloride FOR SOLUTION;ORAL 208630-001 Jun 6, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Dusa LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

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Serving leading biopharmaceutical companies globally:

Merck
Dow
Colorcon
McKinsey
Express Scripts
AstraZeneca

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