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RHOFADE

NDA

OXYMETAZOLINE HYDROCHLORIDE | N208552 | MAYNE PHARMA LLC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

2027

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Today

May. 2, 2028

Dec. 1, 2031

Jun. 11, 2035

Jun. 11, 2035

Jun. 11, 2035

Jun. 11, 2035

Jun. 11, 2035

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
EPI Health, LLC et al v. Padagis Israel Pharmaceuticals Ltd 1:2021cv00498	D. Del.	2021-04-05	Terminated 2021-09-14	—
EPI Health, LLC et al v. Taro Pharmaceuticals, Inc. 1:2019cv01910 5 patentsANDA 213584oxymetazoline HCl (oxymetazoline)	D. Del.	2019-10-08	Terminated 2021-05-24	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

39 trials from ClinicalTrials.gov — 1 recruiting, 31 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea NCT02630121	Phase 4	Recruiting	University of South Florida	52	2023-04-01 → 2026-04
Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects NCT01952990	Phase 2	Completed	St. Renatus, LLC	18	2013-09 → 2013-10
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)NCT01275105	Phase 2	Completed	Eye Therapies, LLC	68	2011-01 → 2011-03
Intranasal Steroids and Oxymetazoline in Allergic Rhinitis NCT00584987	Phase 4	Completed	University of Chicago	64	2007-06 → 2009-07
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults NCT01745380	Phase 3	Completed	St. Renatus, LLC	150	2013-02 → 2013-05
Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis NCT01365650	Phase 1	Completed	Egalet Ltd	24	2007-12 → 2008-06
Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea NCT02132117	Phase 3	Completed	Allergan	445	2014-06 → 2015-05
Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea NCT03380390	Phase 4	Completed	Aclaris Therapeutics, Inc.	46	2017-12-04 → 2018-06-15
Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery NCT03228914	Phase 4	Completed	The University of Texas Health Science Center, Houston	20	2018-06-14 → 2018-08-29
TransMEM Gas Exchange -- Project 1, Aim 2 NCT01925729	Phase 1	Completed	Cuneyt M. Alper	84	2013-10-01 → 2019-03-22

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

$23.47

per gm

Lowest NADAC/Unit

$23.47

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51862076530RHOFADE 1% CREAM	$23.47	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 (2 FSS)

Lowest Price

$431.59

Highest Price

$431.59

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71403-0003-30RHOFADE 1% CREAM,TOP	$431.59	FSS	Mayne Pharma Commercial LLC	07/14/2030
51862-0765-30RHOFADE 1% CREAM,TOP	$431.59	FSS	Mayne Pharma Commercial LLC	07/14/2030

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

Medicare Part D Spending

CMS annual spending data for Rhofade (2024)

Total Spending

$928K

Total Claims

1,474

Beneficiaries

1,269

Avg Cost/Unit

$19.99

Spending Trend

$1.7M(2021)→$2.7M(2022)→$2.5M(2023)→$928K(2024)

YoY Change:+0.9%

5yr CAGR:+3.1%

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

API Supply Chain2 active DMFs

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

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHOXYMETAZOLINE HYDROCHLORIDE

DMF 89401991

CTX LIFE SCIENCES PVT LTDOXYMETAZOLINE HYDROCHLORIDE USP

DMF 224012008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 19, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLDAB

7 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jan 18, 2017

Patents (7) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7812049	May 2, 2028	—	—	—		—
8883838	Dec 1, 2031	—	—	Yes	—	—
9974773	Jun 11, 2035	—	—	—		—
10335391	Jun 11, 2035	—	—	—		—
10751325	Jun 11, 2035	—	—	—		—
11517560	Jun 11, 2035	—	—	—		—
12350255	Jun 11, 2035	—	—	—		—