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OmniRx › Tools › Generic competition check › Aminolevulinic Acid Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Aminolevulinic Acid Hydrochloride, and who makes it?

Aminolevulinic Acid Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 3 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Aminolevulinic Acid Hydrochloride3 dosage-form groups in the Orange Book
0generic makers listed
  1. Aminolevulinic Acid Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 3 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

For Solution, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Gleolan. No generic is listed as marketed.

201520202025203001brand 2017data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Gel, Topical

Brand listed, no generic listed as marketed

Brand listed as marketed: Ameluz. No generic is listed as marketed.

201520202025203020352040204501brand 2016data datePatent 11540981 listed to expire 7 February 2028Patent 11235169 listed to expire 15 October 2040Patent 12280146 listed to expire 8 December 2043Exclusivity D-194 to 4 October 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 4 October 2027Exclusivity D-194 Ameluz
  • 7 February 2028Patent 11540981 drug product
  • 15 October 2040Patent 11235169
  • 8 December 2043Patent 12280146 drug product

Solution, Topical

Brand listed, no generic listed as marketed

Brand listed as marketed: Levulan. No generic is listed as marketed.

199520002005201020152020202520302035204001brand 1999data datePatent 12290700 listed to expire 13 October 2036Patent 11697028 listed to expire 13 October 2036Patent 11179574 listed to expire 13 October 2036Patent 11446512 listed to expire 17 January 2037Patent 11690914 listed to expire 12 January 2038Patent 11077192 listed to expire 12 January 2038Patent 12296011 listed to expire 12 January 2038Patent 10357567 listed to expire 12 January 2038Patent 11571478 listed to expire 12 January 2038Patent 11135293 listed to expire 12 January 2038
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 13 October 2036Patent 12290700
  • 13 October 2036Patent 11697028
  • 13 October 2036Patent 11179574
  • 17 January 2037Patent 11446512
  • 12 January 2038Patent 11690914
  • 12 January 2038Patent 11077192
  • 12 January 2038Patent 12296011
  • 12 January 2038Patent 10357567

2 more patents are listed.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.