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ZILXI

NDA

MINOCYCLINE HYDROCHLORIDE | N213690 | JOURNEY MEDICAL CORP

1 strength9 unique patents0 unique exclusivities

Patent Timeline

9 unique patents by expiration date

Active (9)Today

2027

2028

2029

2030

Today

Oct. 1, 2030

Oct. 1, 2030

Oct. 1, 2030

Oct. 1, 2030

Oct. 1, 2030

Oct. 1, 2030

Oct. 1, 2030

Oct. 1, 2030

Oct. 1, 2030

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
Journey Medical Corporation v. Padagis Israel Pharmaceuticals Ltd. 1:2022cv00587 8 patentsANDA 217148Minocycline hydrochloride	D. Del.	2022-05-02	Terminated 2022-05-19	—

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 Zilxi (2023)

Total Spending

$403K

Total Claims

788

Beneficiaries

453

Avg Cost/Unit

$16.79

Spending Trend

$21K(2020)→$325K(2021)→$372K(2022)→$403K(2023)

YoY Change:+1.0%

5yr CAGR:+1.1%

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

API Supply Chain9 active DMFs7 inactive

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

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE

DMF 137381998

CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SAMINOCYCLINE HYDROCHLORIDE

DMF 137581998

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE)

DMF 148022000

IDT AUSTRALIA LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 150142000

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 260502012

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE MICRONIZED

DMF 290032015

ZHEJIANG MEDICINE CO LTDMINOCYCLINE HYDROCHLORIDE

DMF 326642018

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE) MICRONIZED

DMF 332792018

ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 359392022

PARKE DAVIS AND COInactiveMINOCYCLINE HYDROCHLORIDE CAP

DMF 24081975

FINE CHEMICALS CORPInactiveMINOCYCLINE HYDROCHLORIDE

DMF 71991987

LEDERLE LABORATORIESInactiveMINOCYCLINE HYDROCHLORIDE

DMF 134041998

NIPPON KAYAKU CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137481998

KYOWA HAKKO KOGYO CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137551998

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMINOCYCLINE HYDROCHLORIDE USP

DMF 151712000

HOVIONE FARMACIENCIA SAInactiveMINOCYCLINE

DMF 342172019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 1, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1.5% BASE

RLD

9 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: May 28, 2020

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8865139	Oct 1, 2030	—	—	Yes		—
8945516	Oct 1, 2030	—	—	Yes	—	—
8992896	Oct 1, 2030	—	—	Yes		—
9675700	Oct 1, 2030	—	—	Yes		—
10213512	Oct 1, 2030	—	—	Yes		—
10265404	Oct 1, 2030	—	—	Yes	—	—
10322186	Oct 1, 2030	—	—	—		—
10946101	Oct 1, 2030	—	—	—		—
12138311	Oct 1, 2030	—	—	—		—