Viewing data from:

EPSOLAY

NDA

BENZOYL PEROXIDE | N214510 | MAYNE PHARMA LLC

1 strength14 unique patents0 unique exclusivities

Patent Timeline

14 unique patents by expiration date

Active (14)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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2038

2039

2040

2041

2042

Today

Nov. 27, 2032

Aug. 8, 2028

Feb. 19, 2040

Feb. 19, 2040

Aug. 18, 2040

Feb. 19, 2040

Dec. 27, 2040

Feb. 19, 2040

Feb. 19, 2040

Feb. 19, 2040

Feb. 3, 2028

May. 23, 2041

Dec. 27, 2040

Feb. 3, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center NCT07485322	N/A	Recruiting	Inova Health Care Services	100	2026-06-17 → 2029-07-31

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

Medicare Part D Spending

CMS annual spending data for Epsolay (2023)

Total Spending

$438K

Total Claims

803

Beneficiaries

465

Avg Cost/Unit

$17.05

Spending Trend

$130K(2022)→$438K(2023)

YoY Change:+3.6%

5yr CAGR:+3.6%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZYDUS LIFESCIENCES LTDBENZOYL PEROXIDE HYDROUS USP

DMF 238602010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 26, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%

RLD

14 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Apr 22, 2022

Patents (14)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9687465	Nov 27, 2032	—	—	Yes		—
9868103	Aug 8, 2028	—	—	Yes		—
10933046	Feb 19, 2040	—	—	Yes		—
10945987	Feb 19, 2040	—	—	—		—
11426378	Aug 18, 2040	—	—	—		—
11541026	Feb 19, 2040	—	—	—		—
11628155	Dec 27, 2040	—	—	—		—
11865100	Feb 19, 2040	—	—	—		—
11877997	Feb 19, 2040	—	—	—		—
11986456	Feb 19, 2040	—	—	—		—
12156946	Feb 3, 2028	—	—	Yes	—	—
12257348	May 23, 2041	—	—	Yes		—
12295935	Dec 27, 2040	—	—	—		—
12350382	Feb 3, 2028	—	—	Yes	—	—