Aminolevulinic Acid Hydrochloride Patent Expiration
Aminolevulinic Acid Hydrochloride is Used for treating actinic keratoses on the upper extremities, face, and scalp through photodynamic therapy. It was first introduced by Sun Pharmaceutical Industries Inc
Aminolevulinic Acid Hydrochloride Patents
Given below is the list of patents protecting Aminolevulinic Acid Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Ameluz | US12280146 | Nanoemulsion without propylene glycol | Dec 08, 2043 | Biofrontera |
| Ameluz | US11235169 | Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device | Oct 15, 2040 | Biofrontera |
| Levulan | US10357567 | Methods for photodynamic therapy | Jan 12, 2038 | Sun Pharm Inds Inc |
| Levulan | US11077192 | Methods for photodynamic therapy | Jan 12, 2038 | Sun Pharm Inds Inc |
| Levulan | US11135293 | Methods for photodynamic therapy | Jan 12, 2038 | Sun Pharm Inds Inc |
| Levulan | US11571478 | Methods for photodynamic therapy | Jan 12, 2038 | Sun Pharm Inds Inc |
| Levulan | US11690914 | Methods for photodynamic therapy | Jan 12, 2038 | Sun Pharm Inds Inc |
| Levulan | US12296011 | Methods for photodynamic therapy | Jan 12, 2038 | Sun Pharm Inds Inc |
| Levulan | US11446512 | Adjustable illuminator for photodynamic therapy and diagnosis | Jan 17, 2037 | Sun Pharm Inds Inc |
| Levulan | US11179574 | Method of administering 5-aminolevulinic acid (ALA) to a patient | Oct 13, 2036 | Sun Pharm Inds Inc |
| Levulan | US11697028 | Adjustable illuminator for photodynamic therapy and diagnosis | Oct 13, 2036 | Sun Pharm Inds Inc |
| Levulan | US12290700 | Adjustable illuminator for photodynamic therapy and diagnosis | Oct 13, 2036 | Sun Pharm Inds Inc |
| Ameluz | US11540981 | Nanoemulsion formulation with improved stability and cell penetration | Feb 07, 2028 | Biofrontera |
| Ameluz | US6559183 | Nano-emulsion of 5-aminolevulinic acid |
Nov 12, 2019
(Expired) | Biofrontera |
| Levulan | US7723910 | Method of photodynamically diagnosing or treating a contoured surface |
Jun 17, 2019
(Expired) | Sun Pharm Inds Inc |
| Levulan | US6709446 | Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light |
May 01, 2018
(Expired) | Sun Pharm Inds Inc |
| Levulan | US8216289 | Illuminator for photodynamic therapy |
May 01, 2018
(Expired) | Sun Pharm Inds Inc |
| Levulan | US8758418 | Illuminator for photodynamic therapy |
May 01, 2018
(Expired) | Sun Pharm Inds Inc |
| Levulan | US5954703 | Method and apparatus for applying 5-aminolevulinic acid |
Oct 31, 2017
(Expired) | Sun Pharm Inds Inc |
| Levulan | US5079262 | Method of detection and treatment of malignant and non-malignant lesions utilizing 5-aminolevulinic acid |
Sep 30, 2013
(Expired) | Sun Pharm Inds Inc |
Aminolevulinic Acid Hydrochloride's Family Patents
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Clinical Trials
Recent Clinical Trials on Aminolevulinic Acid Hydrochloride:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| PDT Plus Vitamin D3 for Anal Dysplasia | Abramson Cancer Center at Penn Medicine | NA |
WITHDRAWN
(Aug 1, 2026)
| PHASE1 |
| Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp | Biofrontera Inc. | NA |
COMPLETED
(Jul 1, 2026)
| PHASE3 |
| Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer | Roswell Park Cancer Institute | NA |
RECRUITING
(Jun 1, 2026)
| PHASE1, PHASE2 |
| A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma | Hemerion Therapeutics | NA |
ACTIVE NOT RECRUITING
(May 1, 2026)
| PHASE1, PHASE2 |
| Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma | NX Development Corp | NA |
COMPLETED
(Apr 1, 2026)
| PHASE3 |