Viewing data from:

RETIN-A

NDA

TRETINOIN | N017955 | BAUSCH HEALTH US LLC

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

98 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 69 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Randomised Trial of ATRA in a Novel Drug Combination for Pancreatic Cancer NCT04241276	Phase 2	Active	Queen Mary University of London	170	2020-04-30 → 2029-02-28
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia NCT02339740	Phase 3	Active	Children's Oncology Group	158	2015-07-21 → 2029-06-30
Testing Safe Doses of Anti-Cancer Medicines, 5-Flurouracil (5-FU) and Tretinoin (ATRA), Added to the Usual Cancer Treatment of Ependymoma NCT07848568	Phase 1/2	Not Yet Recruiting	Children's Oncology Group	70	2026-12-11 → 2037-06-30
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia NCT01409161	Phase 2	Recruiting	M.D. Anderson Cancer Center	151	2011-10-05 → 2027-12-18
Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma NCT06528769	Phase 2	Recruiting	Gabriel Tinoco	16	2025-09-10 → 2027-12-31
Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)NCT04303169	Phase 1/2	Completed	Merck Sharp & Dohme LLC	146	2020-06-26 → 2025-09-24
UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia NCT00003598	N/A	Completed	University of Michigan Rogel Cancer Center	180	1999-01 → 2009-11
Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea NCT00823901	Phase 2/3	Completed	Massachusetts General Hospital	83	2009-02 → 2010-10
Randomized Split-Face Controlled Study to Evaluate the Effectiveness of Topical Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% as Compared to Topical Tretinoin 0.05% + Hydroquinone 4% + Fluocinolone 0.01% for the Treatment of Melasma NCT07876323	Phase 2	Completed	National Skin Centre	30	2023-06-06 → 2024-07-11
Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel NCT02249767	Phase 3	Completed	Spear Pharmaceuticals	574	2013-11 → 2014-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$2.42

per gm

Lowest NADAC/Unit

$2.15

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00378808515TRETINOIN 0.01% GEL	$2.42	GM	Generic	—	2026-10-21
00378808545TRETINOIN 0.01% GEL	$2.15	GM	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$6.78

Highest Price

$126.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00378-8085-15TRETINOIN 0.01% GEL,TOP	$18.66	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-8085-15TRETINOIN 0.01% GEL,TOP	$34.99	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-8085-45TRETINOIN 0.01% GEL,TOP	$43.60	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00378-8085-45TRETINOIN 0.01% GEL,TOP	$126.18	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
00187-5172-15RETIN-A 0.01 % TOP GEL	$6.78	Big4	Bausch Health US, LLC	04/30/2026
00187-5172-15RETIN-A 0.01 % TOP GEL	$6.78	FSS	Bausch Health US, LLC	04/30/2026
00187-5172-45RETIN-A 0.01% GEL TOP	$15.83	Big4	Bausch Health US, LLC	04/30/2026
00187-5172-45RETIN-A 0.01% GEL TOP	$15.83	FSS	Bausch Health US, LLC	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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 -23	View Letter (PDF)
Jun 10, 2002	SUPPL -19	View Letter (PDF)
Jun 10, 2002	SUPPL -20	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.01%

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.