Viewing data from:

FABIOR

NDA

TAZAROTENE | N202428 | MAYNE PHARMA LLC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

Today

8808716

Feb. 24, 2030

10568859

Feb. 24, 2030

10688071

Feb. 24, 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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Fabior (2023)

Total Spending

$79K

Total Claims

Beneficiaries

Avg Cost/Unit

$12.80

Spending Trend

$145K(2019)→$115K(2020)→$103K(2021)→$69K(2022)→$79K(2023)

YoY Change:-3.0%

5yr CAGR:+4.1%

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

API Supply Chain3 active DMFs4 inactive

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

ALIVUS LIFE SCIENCES LTDTAZAROTENE

DMF 214222008

PCASTAZAROTENE

DMF 251612011

OLON SPATAZAROTENE

DMF 296002015

CARDINAL HEALTH PTS LLCInactiveTAZAROTENE 1.5 MG AND 4.5 MG CAPSULES

DMF 168642003

BASF SEInactiveTAZAROTENE

DMF 190892006

WATSON PHARMA PRIVATE LTDInactiveTAZAROTENE

DMF 200632006

PIRAMAL HEALTHCARE CANADA LTDInactiveTAZAROTENE

DMF 248742011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 16, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLD

3 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: May 11, 2012

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8808716	Feb 24, 2030	—	—	Yes	—	—
10568859	Feb 24, 2030	—	—	Yes		—
10688071	Feb 24, 2030	—	—	Yes		—