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AMELUZ

NDA

AMINOLEVULINIC ACID HYDROCHLORIDE | N208081 | BIOFRONTERA INC

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivityIPRPTAB Challenge

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Today

11235169

Oct. 15, 2040

11540981

Feb. 7, 2028

12280146

Dec. 8, 2043IPR×2

D-194

Oct. 4, 2027

PTAB Proceedings

2 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2026-00396	12280146	IPR	Sun Pharmaceutical Industries, Inc. et al.	Pending	2026-07-09	—
PGR2026-00021	12280146	PGR	Sun Pharmaceutical Industries, Inc.	Discretionary Denial	2026-01-16	2026-05-26

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

73 trials from ClinicalTrials.gov — 3 recruiting, 1 active, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ALA-induced PpIX Fluorescence During Brain Tumor Resection NCT02191488	Phase 1	Active	David W. Roberts	540	2014-07 → 2026-12-31
Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker NCT02691923	Phase 2	Recruiting	David W. Roberts	30	2016-03 → 2026-12
Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II NCT02728388	Phase 2	Recruiting	Donald Basel	30	2016-08 → 2025-12
Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors NCT01898416	Phase 2	Recruiting	michal roll	140	2013-06 → 2026-12
Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol NCT02644187	N/A	Completed	Vastra Gotaland Region	30	2015-12 → 2017-03
Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid NCT04164849	Phase 1/2	Completed	University Hospital, Akershus	7	2019-11-22 → 2023-10-31
Treatment of Oral Premalignant Lesions With 5-ALA PDT NCT00571974	Phase 1/2	Completed	University of Arkansas	29	2007-01 → 2012-01
A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors NCT01128218	Phase 1/2	Completed	Southern Illinois University	33	2011-03 → 2021-02
Photodynamic Therapy for Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion as a Light Sensitizing Cream NCT02685592	Phase 4	Completed	Joint Authority for Päijät-Häme Social and Health Care	10	2016-02 → 2018-03
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis NCT02409732	Phase 4	Completed	Dartmouth-Hitchcock Medical Center	24	2015-04 → 2017-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$238.54

Highest Price

$3490.99

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70621-0101-10AMELUZ 10% GEL,TOP	$349.10	FSS	Biofrontera Inc.	06/14/2029
70621-0101-10AMELUZ 10% GEL,TOP	$238.54	Big4	Biofrontera Inc.	06/14/2029
70621-0101-20AMELUZ 10% GEL,TOP	$3490.99	FSS	Biofrontera Inc.	06/14/2029
70621-0101-20AMELUZ 10% GEL,TOP	$2559.22	Big4	Biofrontera Inc.	06/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part B Spending

CMS physician-administered drug spending for Ameluz (2024)

Total Spending

$16.0M

Total Claims

48,458

Beneficiaries

30,905

ASP Price

$1.70

Spending Trend

$10.3M(2019)→$9.2M(2020)→$10.7M(2021)→$12.0M(2022)→$13.9M(2023)→$16.0M(2024)

YoY Change:+2.6%

5yr CAGR:+3.2%

HCPCS: J7345 — Aminolevulinic acid hcl for topical administration, 10% gel, 10 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 7, 2024	SUPPL -28	View Letter (PDF)
Mar 18, 2024	SUPPL -26	View Letter (PDF)
May 26, 2021	SUPPL -11	View Letter (PDF)
Sep 8, 2017	SUPPL -2	View Letter (PDF)
May 16, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10%

RLD

3 patents1 exclusivity▴

GEL;TOPICAL | Approved: May 10, 2016

Patents (3) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11235169	Oct 15, 2040	—	—	—		—
11540981	Feb 7, 2028	—	—	Yes	—	—
12280146	Dec 8, 2043	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
D-194	Oct 4, 2027	Active