Viewing data from:

WINLEVI

NDA

CLASCOTERONE | N213433 | SUN PHARMACEUTICAL INDUSTRIES LTD

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Expiring < 1yr (1)Active (7)Today

2027

2028

2029

2030

Today

Jan. 12, 2027

Jul. 25, 2030

Feb. 28, 2029

Jul. 24, 2028

Aug. 14, 2028

Nov. 20, 2028

Jul. 24, 2028

Jul. 24, 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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
CASSIOPEA S.P.A. et al v. AUROBINDO PHARMA LTD. et al 2:2024cv10734 6 patentsANDA 219862clascoterone	D.N.J.	2024-11-25	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)NCT02608450	Phase 3	Completed	Cassiopea SpA	708	2016-01-21 → 2018-04-11
A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris NCT01631474	Phase 2	Completed	Intrepid Therapeutics, Inc.	363	2012-06 → 2014-02
An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris NCT01831960	Phase 2	Completed	Intrepid Therapeutics, Inc.	42	2013-04 → 2013-11
A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)NCT02608476	Phase 3	Completed	Cassiopea SpA	732	2015-11-16 → 2018-02-21
An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris NCT02682264	Phase 3	Completed	Cassiopea SpA	609	2016-03-09 → 2018-08-31

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$10.00

per gm

Lowest NADAC/Unit

$10.00

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
47335099436WINLEVI 1% CREAM	$10.00	GM	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$410.69

Highest Price

$601.69

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
47335-0994-36WINLEVI 1% CREAM,TOP	$601.69	FSS	Sun Pharmaceutical Industries, Inc.	07/14/2026
47335-0994-36WINLEVI 1% CREAM,TOP	$410.69	Big4	Sun Pharmaceutical Industries, Inc.	07/14/2026

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

Medicare Part D Spending

CMS annual spending data for Winlevi (2024)

Total Spending

$1.1M

Total Claims

1,883

Beneficiaries

809

Avg Cost/Unit

$9.64

Spending Trend

$21K(2021)→$515K(2022)→$880K(2023)→$1.1M(2024)

YoY Change:-5.9%

5yr CAGR:+1.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

YANGZHOU AURISCO PHARMACEUTICAL CO LTDCLASCOTERONE

DMF 377102024

TAPI NL BVCLASCOTERONE

DMF 395142024

WAVELENGTH ENTERPRISES LTDCLASCOTERONE

DMF 399352024

STEROID SPACLASCOTERONE

DMF 418962025

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDCLASCOTERONE

DMF 435122026

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 21, 2022	SUPPL -2	View Letter (PDF)
Aug 31, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

8 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Aug 26, 2020

Patents (8) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8143240	Jan 12, 2027	—	—	—		—
8785427	Jul 25, 2030	—	—	Yes	—	—
9433628	Feb 28, 2029	—	—	Yes	—	—
9486458	Jul 24, 2028	—	—	—		—
10159682	Aug 14, 2028	—	—	—		—
11207332	Nov 20, 2028	—	—	Yes		—
11938141	Jul 24, 2028	—	—	Yes	—	—
12337002	Jul 24, 2028	—	—	Yes		—