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RETIN-A

NDA

TRETINOIN | N016921 | VALEANT INTERNATIONAL BARBADOS SRL

2 strengths0 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

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of New Trio Combination for Melasma NCT07676994	Phase 4	Completed	Ghurki Trust and Teaching Hospital	56	2025-05-07 → 2026-01-01
Systemic Isotretinoin Therapy and Eye NCT07675460	N/A	Completed	Demet Mutlu	60	2024-04-01 → 2025-11-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Retin-A (2023)

Total Spending

$1.2M

Total Claims

30,618

Beneficiaries

14,269

Avg Cost/Unit

$1.24

Spending Trend

$1.3M(2019)→$1.2M(2020)→$1.4M(2021)→$1.6M(2022)→$1.2M(2023)

YoY Change:-37.5%

5yr CAGR:-11.1%

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

3 letters from Drugs@FDA

Date	Submission	Document
Jun 10, 2002	SUPPL -21	View Letter (PDF)
Jun 10, 2002	SUPPL -22	View Letter (PDF)
Jun 10, 2002	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 0.05%

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 0.05%

0 patents0 exclusivities▾

SWAB;TOPICAL | Approved: Approved Prior to Jan 1, 1982