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FDA Orange Book · active-ingredient family

Aminolevulinic acid hydrochloride

Aminolevulinic acid hydrochloride is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:GLEOLAN · NDA 208630

3

Brand (NDA)

0

Generics (ANDA)

13

Listed patents

1

Exclusivity periods

Brand (NDA) products · for solution, gel, solution

ProductApplicantApplicationTEApproved
GLEOLANRLDNXDCNDA 208630—Jun 06, 2017
AMELUZRLDBIOFRONTERANDA 208081—May 10, 2016
LEVULANRLDSUN PHARM INDS INCNDA 020965—Dec 03, 1999

Marketing exclusivity (1)

  • D-194New indication / change exclusivity (3 years)

    Oct 04, 2027

    in 1 yr 4 mo

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11540981Feb 07, 2028in 1 yr 8 mo
Product
12290700Oct 13, 2036in 10 yr 6 mo
U-804
11697028Oct 13, 2036in 10 yr 6 mo
U-804
11179574Oct 13, 2036in 10 yr 6 mo
U-804
11446512Jan 17, 2037in 10 yr 9 mo
U-804
11690914Jan 12, 2038in 11 yr 9 mo
U-3163
11077192Jan 12, 2038in 11 yr 9 mo
U-3163
12296011Jan 12, 2038in 11 yr 9 mo
U-3163
10357567Jan 12, 2038in 11 yr 9 mo
U-3163
11571478Jan 12, 2038in 11 yr 9 mo
U-3163
11135293Jan 12, 2038in 11 yr 9 mo
U-3163
11235169Oct 15, 2040in 14 yr 6 mo
U-3303
12280146Dec 08, 2043in 17 yr 9 mo
Product

Aminolevulinic acid hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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