Viewing data from:

ARAZLO

NDA

TAZAROTENE | N211882 | BAUSCH HEALTH US LLC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)TodayIPRPTAB Challenge

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

11311482

May. 11, 2038IPR

11679116

Jun. 6, 2036

12128137

May. 11, 2038

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2023-01114	11311482	IPR	Padagis Israel Pharmaceuticals Ltd. et al.	Institution Denied	2023-06-21	2024-01-12

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Arazlo (2023)

Total Spending

$290K

Total Claims

526

Beneficiaries

318

Avg Cost/Unit

$11.91

Spending Trend

$20K(2020)→$112K(2021)→$217K(2022)→$290K(2023)

YoY Change:+9.8%

5yr CAGR:+6.2%

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
Dec 20, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.045%

RLD

3 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Dec 18, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11311482	May 11, 2038	—	—	—		—
11679116	Jun 6, 2036	—	—	Yes	—	—
12128137	May 11, 2038	—	—	Yes		—