Viewing data from:

RETIN-A MICRO

NDA

TRETINOIN | N020475 | BAUSCH HEALTH US LLC

4 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

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 Retin-A Micro (2023)

Total Spending

$187K

Total Claims

377

Beneficiaries

174

Avg Cost/Unit

$12.66

Spending Trend

$248K(2019)→$230K(2020)→$235K(2021)→$234K(2022)→$187K(2023)

YoY Change:-1.9%

5yr CAGR:-0.3%

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
Apr 7, 2026	SUPPL -36	View Letter (PDF)
Sep 11, 2025	SUPPL -29	View Letter (PDF)
May 10, 2002	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.1%

RLD

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Feb 7, 1997

No patent or exclusivity listings for this strength.

#002 — 0.04%

RLD

0 patents0 exclusivities▾

GEL;TOPICAL | Approved: May 10, 2002

#003 — 0.08%

RLDAB

0 patents0 exclusivities▾

GEL;TOPICAL | Approved: Jan 28, 2014

#004 — 0.06%

RLDAB

0 patents0 exclusivities▾

GEL;TOPICAL | Approved: Oct 23, 2017