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LEVULAN

NDA

AMINOLEVULINIC ACID HYDROCHLORIDE | N020965 | SUN PHARMACEUTICAL INDUSTRIES INC

1 strength10 unique patents0 unique exclusivities

Patent Timeline

10 unique patents by expiration date

Active (10)TodayIPRPTAB Challenge

2026

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2031

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2038

Today

Jan. 12, 2038IPR

Jan. 12, 2038

Jan. 12, 2038

Oct. 13, 2036

Jan. 17, 2037IPR

Jan. 12, 2038

Jan. 12, 2038

Oct. 13, 2036IPR×2

Oct. 13, 2036

Jan. 12, 2038

PTAB Proceedings

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

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2022-00056	10357567	IPR	Biofrontera Inc. et al.	Terminated	2021-10-19	2022-01-24
IPR2024-00874	11697028	IPR	Biofrontera AG et al.	Institution Denied	2024-04-30	2024-11-12
IPR2024-01312	11697028	IPR	Biofrontera Incorporated et al.	Pending Director Review	2024-08-21	2026-02-23
IPR2025-00287	11446512	IPR	Biofrontera Incorporated et al.	Discretionary Denial	2024-12-27	2025-07-02

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
DUSA Pharmaceuticals, Inc. v. Biofrontera Inc. et al 1:2018cv10568 2 patentsaminolevulinic acid (ALA)	D. Mass.	2018-03-23	Terminated 2021-11-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

ITC Section 337 Investigations

International Trade Commission investigations involving patents listed for this drug.

Pending before the Commission337-TA-1411Instituted: Jul. 26, 2024

Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination with the Same; Inv. No. 337-TA-1411 (Violation)

Source: USITC Investigative Data System (IDS). Matched via patent overlap.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor NCT05590689	Phase 1/2	Recruiting	Universität Münster	34	2022-11-09 → 2028-01

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

Medicare Part D Spending

CMS annual spending data for Levulan (2023)

Total Spending

$310K

Total Claims

595

Beneficiaries

499

Avg Cost/Unit

$411.72

Spending Trend

$113K(2019)→$140K(2020)→$161K(2021)→$196K(2022)→$310K(2023)

YoY Change:+5.3%

5yr CAGR:+3.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Levulan (2023)

Total Spending

$39.9M

Total Claims

92,924

Beneficiaries

63,865

ASP Price

—

HCPCS: J7308 — Aminolevulinic acid hcl for topical administration, 20%, single unit dosage form (354 mg)

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
May 10, 2022	SUPPL -17	View Letter (PDF)
Apr 23, 2018	SUPPL -16	View Letter (PDF)
Mar 12, 2018	SUPPL -15	View Letter (PDF)
Mar 18, 2010	SUPPL -7	View Letter (PDF)
Nov 20, 2009	SUPPL -6	View Letter (PDF)
Jul 28, 2003	SUPPL -4	View Letter (PDF)
Jul 6, 2003	SUPPL -3	View Letter (PDF)
Mar 28, 2003	SUPPL -2	View Letter (PDF)
Dec 7, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20%

RLD

10 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Dec 3, 1999

Patents (10)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10357567	Jan 12, 2038	—	—	—	—
11077192	Jan 12, 2038	—	—	—	—
11135293	Jan 12, 2038	—	—	—	—
11179574	Oct 13, 2036	—	—	—	—
11446512	Jan 17, 2037	—	—	—	—
11571478	Jan 12, 2038	—	—	—	—
11690914	Jan 12, 2038	—	—	—	—
11697028	Oct 13, 2036	—	—	—	—
12290700	Oct 13, 2036	—	—	—	—
12296011	Jan 12, 2038	—	—	—	—