Viewing data from:

ATRALIN

NDA

TRETINOIN | N022070 | DOW PHARMACEUTICAL SCIENCES

1 strength0 unique patents0 unique exclusivities

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 Atralin (2023)

Total Spending

$7K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$13.24

Spending Trend

$30K(2019)→$29K(2020)→$14K(2021)→$10K(2022)→$7K(2023)

YoY Change:-1.0%

5yr CAGR:+0.9%

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

API Supply Chain6 active DMFs4 inactive

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

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHTRETINOIN

DMF 34561978

OLON SPATRETINOIN

DMF 74741988

AMCOL HEALTH AND BEAUTY SOLUTIONS INCTRETINOIN 4% IN POLY-POREr POLYMER (TRETINOIN IN ALLYL METHACRYLATES CROSSPOLYMER)

DMF 231862009

OLON SPATRETINOIN TYPE 2

DMF 251922011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTRETINOIN

DMF 269222013

CHONGQING HUAPONT PHARMACEUTICAL CO LTDTRETINOIN

DMF 273982013

DSM NUTRITIONAL PRODUCTS LTDInactiveTRETINOIN (ALL-TRANS-RETINDE, ACID)

DMF 77341988

SHANGHAI NO 6 PHARMACEUTICAL FACTORYInactiveTRETINOIN

DMF 79961989

HOFFMANN LA ROCHE INCInactiveTRETINOIN CAPSULES

DMF 85921990

RANBAXY LABORATORIES LTDInactiveTRETINOIN USP (NON STERILE BULK)

DMF 244202010

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 3, 2014	SUPPL -3	View Letter (PDF)
Jul 30, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

RLDAB

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jul 26, 2007

No patent or exclusivity listings for this strength.