ULTRAVATE Drug Patent Profile

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Which patents cover Ultravate, and what generic alternatives are available?

Ultravate is a drug marketed by Sun Pharm Inds Inc and Mical Pharms and is included in three NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in eighteen countries.

The generic ingredient in ULTRAVATE is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ultravate

A generic version of ULTRAVATE was approved as halobetasol propionate by FOUGERA PHARMS on December 16^th, 2004.

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Summary for ULTRAVATE

International Patents:	22
US Patents:	1
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	8
Patent Applications:	4,752
Drug Prices:	Drug price information for ULTRAVATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ULTRAVATE
What excipients (inactive ingredients) are in ULTRAVATE?	ULTRAVATE excipients list
DailyMed Link:	ULTRAVATE at DailyMed

Drug patent expirations by year for ULTRAVATE

Recent Clinical Trials for ULTRAVATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 1

See all ULTRAVATE clinical trials

Pharmacology for ULTRAVATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for ULTRAVATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULTRAVATE	Lotion	halobetasol propionate	0.05%	208183	1	2018-01-24

US Patents and Regulatory Information for ULTRAVATE

ULTRAVATE is protected by one US patents.

Patents protecting ULTRAVATE

Topical steroid composition and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF A LOTION CONTAINING HALOBETASOL PROPIONATE FOR THE TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES INCLUDING PSORIASIS

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967-001	Dec 27, 1990		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mical Pharms	ULTRAVATE	halobetasol propionate	LOTION;TOPICAL	208183-001	Nov 6, 2015		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ULTRAVATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	CREAM;TOPICAL	019967-001	Dec 27, 1990	⤷ Sign Up	⤷ Sign Up
Sun Pharm Inds Inc	ULTRAVATE	halobetasol propionate	OINTMENT;TOPICAL	019968-001	Dec 17, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ULTRAVATE

See the table below for patents covering ULTRAVATE around the world.

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Country	Patent Number	Title	Estimated Expiration
Sweden	423903	FORFARANDE FOR FRAMSTELLNING AV 9 ALFA, 21-DIHALOGEN-11 BETA,17 ALFA-DIHYDROXI-6 ALFA-FLOUR-16 ALFA-METYL-PREGNA-1,4-DIEN-3,20-DION-ESTRAR	⤷ Sign Up
Austria	A81179		⤷ Sign Up
Austria	A913976		⤷ Sign Up
Switzerland	631998	Process for the preparation of polyhalogenated steroids	⤷ Sign Up
Switzerland	632521	Process for the preparation of polyhalogenated steroids	⤷ Sign Up
Canada	1056371	STEROIDES POLYHALOGENES ET PROCEDE DE FABRICATION (POLYHALOGENO-STEROIDS AND PROCESSES FOR THEIR MANUFACTURE)	⤷ Sign Up
German Democratic Republic	133150	VERFAHREN ZUR HERSTELLUNG VON MEHRFACH HALOGENIERTEN STEROIDEN	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration