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Aminolevulinic Acid Hydrochloride

Sold as AMELUZ, GLEOLAN, LEVULAN · given by oral, topical

Ten years or more until it comes off patent
17.3 yr
Until anyone may copy it
Protection runs to 2043-12-08
14
Trials running now
297 registered in total
In routine use
Furthest stage reached
already in routine clinical use
3
Organisations running trials
lead sponsors on record
01

Who owns it, and until when

Biofrontera Inc
Approval holder
the only company permitted to sell it today
2043-12
Last patent expires
latest patent filed against this product
2027-10
FDA exclusivity ends
a separate protection granted at approval

Whichever date falls later is when other manufacturers may apply to sell copies. Price typically falls steeply within a year of that point, and with it any company's ability to recover the cost of new research on the molecule. That is when it becomes a candidate for the ledger on the first tab.

02

What it is being tested for

Actinic KeratosisBladder CancerGlioblastoma
03

Who is paying for the research

Photocure
Company
5
Roswell Park Cancer Institute
University or hospital
3
Biofrontera Inc.
Company
2

Who funds the trials matters after protection lapses. Company-funded work usually stops once exclusivity ends; university, hospital and government-funded work does not, and is the research most likely to continue on this molecule afterwards.

04

The trials themselves

NCT07038278Phase 12026 · 20 people · not yet recruiting
5-AminoLevulinic Acid Aided Resection Margin

Expiry dates are what the patent holder has filed; litigation, paediatric extensions and settlements routinely move them, so read these as the earliest plausible date rather than a schedule. Not medical advice.

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