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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

2028

2029

2030

2031

2032

2033

2034

2035

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Rhofade (2023)

Total Spending

$2.5M

Total Claims

3,972

Beneficiaries

2,559

Avg Cost/Unit

$19.80

Spending Trend

$1.7M(2021)→$2.7M(2022)→$2.5M(2023)

YoY Change:+4.4%

5yr CAGR:+4.2%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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	—	—	—		—

Change History (1)

Recent changes detected for this application.

MODIFIEDTE Code7/1/2026

Oxymetazoline hydrochloride (RHOFADE) received an AB therapeutic equivalence rating, indicating FDA has determined it is therapeutically equivalent to reference products and eligible for generic substitution.

New: AB