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ULTRAVATE

NDA

HALOBETASOL PROPIONATE | N019968 | SUN PHARMACEUTICAL INDUSTRIES INC

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
Citizen Petition from Lachman Consultants Services, Inc FDA-2017-P-4194 · 3 docket documents Lachman Consultants Services, Inc. filed this citizen petition requesting that the FDA designate either Halobetasol Propionate Ointment 0.05% held by Perrigo Israel Pharmaceuticals Ltd under ANDA A076872 or Halobetasol Propionate Ointment 0.05% held by G and W Laboratories Inc under ANDA A077721 as	505(q)	2017-07-14	Withdrawn	Lachman Consultants Services, Inc

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

Clinical Trials

11 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis NCT01404338	Phase 1	Completed	Patel, Rita Vikram, M.D.	10	2011-06
The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects NCT00865267	Phase 1	Completed	Actavis Inc.	20	2003-12 → 2003-12
Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis NCT01166646	Phase 2	Completed	Therapeutics, Inc.	43	2010-07 → 2011-07
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis NCT03992261	Phase 4	Completed	Mayne Pharma International Pty Ltd	24	2019-06-14 → 2019-12-30
Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis NCT00715975	Phase 2/3	Completed	Azidus Brasil	140	2008-07 → 2010-08
Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis NCT00990561	Phase 4	Completed	University of California, San Francisco	40	2009-07 → 2010-06
Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects NCT00865605	Phase 1	Completed	Actavis Inc.	71	2003-12 → 2004-07
A Study to Determine the Efficacy and Safety of Halobetasol Propionate Lotion 0.05% in Subjects With Plaque Psoriasis NCT01610596	Phase 2	Completed	Therapeutics, Inc.	72	2011-11 → 2012-02
Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%NCT03212963	Phase 4	Terminated	Sun Pharmaceutical Industries Limited	16	2017-03-21 → 2019-08-12
Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis NCT03245385	Phase 2	Terminated	Sun Pharmaceutical Industries Limited	20	2017-07-24 → 2018-02-05

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

API Supply Chain7 active DMFs2 inactive

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

WAVELENGTH ENTERPRISES LTDHALOBETASOL PROPIONATE

DMF 168562003

STERLING SPAHALOBETASOL PROPIONATE

DMF 168612003

HOVIONE FARMACIENCIA SAHALOBETASOL PROPIONATE

DMF 169532003

TARO PHARMACEUTICAL INDUSTRIES LTDHALOBETASOL PROPIONATE USP, MICRONIZED

DMF 175292004

TRIFARMA SPAHALOBETASOL PROPIONATE

DMF 185662005

SYMBIOTEC PHARMALAB PRIVATE LTDHALOBETASOL PROPIONATE

DMF 194022006

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDHALOBETASOL PROPIONATE

DMF 309062016

SAFC INCInactiveHALOBETASOL PROPIONATE (HBS)

DMF 163292002

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveHALOBETASOL PROPIONATE

DMF 169442003

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 4, 2012	SUPPL -11	View Letter (PDF)
Sep 17, 2004	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Dec 17, 1990

No patent or exclusivity listings for this strength.