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SORIATANE

NDA

ACITRETIN | N019821 | STIEFEL LABORATORIES INC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Connetics Corporation - Citizen Petition FDA-2006-P-0451 · 10 docket documents Connetics Corporation filed this citizen petition in March 2006 under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA withhold approval of any abbreviated new drug application for a generic version of acitretin capsules (Soriatane) until the applicant	505(q)	2008-07-14	Partially Denied	—

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

Clinical Trials

23 trials from ClinicalTrials.gov — 1 recruiting, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis NCT04239859	Phase 4	Not Yet Recruiting	Singapore General Hospital	40	2024-01 → 2027-12
Dose Ranging Study to Assess the Efficacy and Safety of Acitretin in Severe Plaque Type Psoriasis NCT01039142	Phase 4	Completed	Post Graduate Institute of Medical Education and Research, Chandigarh	61	2008-03 → 2009-03
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis NCT00395941	Phase 2	Completed	Post Graduate Institute of Medical Education and Research, Chandigarh	40	2006-12 → 2008-12
Alzheimer's Disease Acitretin Medication NCT01078168	Phase 2	Completed	K. Lieb	22	2010-03 → 2013-05
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis NCT00936065	Phase 4	Completed	Pfizer	60	2009-07 → 2011-04
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation NCT00003611	N/A	Completed	Alliance for Clinical Trials in Oncology	129	2000-05 → 2003-06
Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis NCT01545284	Phase 2/3	Completed	Innovaderm Research Inc.	9	2012-03 → 2014-01
Acitretin and Etanercept in Psoriasis NCT00156247	Phase 2	Completed	University of Medicine and Dentistry of New Jersey	10	2005-09 → 2009-03
Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis NCT02191020	N/A	Completed	Xijing Hospital	108	2013-02 → 2013-10
Evaluation of the Efficacy of Acitretin Therapy for Nail Psoriasis NCT00723437	Phase 4	Completed	Istituti Fisioterapici Ospitalieri	36	2005-01 → 2008-07

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

Medicare Part D Spending

CMS annual spending data for Acitretin (2024)

Total Spending

$13.8M

Total Claims

45,250

Beneficiaries

10,125

Avg Cost/Unit

$7.46

Spending Trend

$22.9M(2019)→$23.0M(2020)→$21.3M(2021)→$20.9M(2022)→$20.9M(2023)→$13.8M(2024)

YoY Change:-39.6%

5yr CAGR:-14.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs2 inactive

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

OLON SPAACITRETIN

DMF 170012003

SOLARA ACTIVE PHARMA SCIENCES LTDACITRETIN

DMF 223582008

USV PRIVATE LTDACITRETIN USP

DMF 233102009

OLON SPAACITRETIN (FORM I)

DMF 244302010

CHONGQING HUAPONT PHARMACEUTICAL CO LTDACITRETIN

DMF 246212011

GLOPEC INTERNATIONAL INCACITRETIN

DMF 261822012

SUN PHARMACEUTICAL INDUSTRIES LTDACITRETIN USP

DMF 288962014

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveACITRETIN USP

DMF 165802003

BASF SEInactiveACITRETIN

DMF 220902008

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Feb 23, 2023	SUPPL -29	View Letter (PDF)
Sep 29, 2017	SUPPL -28	View Letter (PDF)
May 22, 2015	SUPPL -27	View Letter (PDF)
May 19, 2014	SUPPL -24	View Letter (PDF)
Feb 20, 2014	SUPPL -22	View Letter (PDF)
Feb 4, 2014	SUPPL -23	View Letter (PDF)
Nov 28, 2011	SUPPL -18	View Letter (PDF)
Feb 16, 2010	SUPPL -17	View Letter (PDF)
Oct 22, 2007	SUPPL -15	View Letter (PDF)
Oct 22, 2007	SUPPL -14	View Letter (PDF)
Nov 8, 2004	SUPPL -12	View Letter (PDF)
Oct 15, 2004	SUPPL -11	View Letter (PDF)
Mar 24, 2004	SUPPL -10	View Letter (PDF)
May 29, 2003	SUPPL -2	View Letter (PDF)
May 29, 2003	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

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

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 28, 1996

No patent or exclusivity listings for this strength.

#002 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 28, 1996

#003 — 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 6, 2009

#004 — 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 6, 2009