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VESANOID

NDA

TRETINOIN | N020438 | CHEPLAPHARM ARZNEIMITTEL GMBH

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Rakoczy Molino Mazzochi Siwik LLP - Citizen Petition FDA-2010-P-0157 · 6 docket documents Rakoczy Molino Mazzochi Siwik LLP filed this citizen petition on March 17, 2010, requesting that the FDA determine whether Hoffman-La Roche voluntarily withdrew VESANOID (Tretinoin) Capsules, 10 mg, from the market for reasons unrelated to safety or effectiveness, and if so, permit abbreviated new d	505(q)	2010-03-26	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

94 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 67 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
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
A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products NCT01313728	Phase 4	Completed	Bausch Health Americas, Inc.	26	2010-12 → 2011-01
Sequential ATRA Then IL-2 for Modulation of Dendritic Cells and Treatment of Metastatic Renal Cell Cancer NCT00100906	Phase 2	Completed	H. Lee Moffitt Cancer Center and Research Institute	18	2004-08 → 2013-07
Tretinoin With or Without Fenretinide in Treating Patients With Dysplastic Nevus Syndrome NCT00003601	Phase 2	Completed	Eastern Cooperative Oncology Group	38	1999-02-23 → 2004-03-02
Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes NCT00382200	Phase 1/2	Completed	Memorial Sloan Kettering Cancer Center	54	2006-07 → 2023-01-05
Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face NCT00919191	Phase 4	Completed	Bausch Health Americas, Inc.	26	2009-04 → 2009-05
Proof of Concept Study to Investigate the Recurrence of Acne Post Isotretinoin NCT00939133	Phase 4	Completed	Dermatrials Research	20	2009-07 → 2010-12
Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia NCT00003934	Phase 3	Completed	National Cancer Institute (NCI)	420	1999-06

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

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

6 letters from Drugs@FDA

Date	Submission	Document
Oct 7, 2024	SUPPL -9	View Letter (PDF)
Feb 22, 2023	SUPPL -7	View Letter (PDF)
Feb 22, 2023	SUPPL -8	View Letter (PDF)
Jul 8, 2008	SUPPL -6	View Letter (PDF)
Oct 8, 2004	SUPPL -4	View Letter (PDF)
Feb 14, 2000	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 22, 1995

No patent or exclusivity listings for this strength.