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Last Updated: December 4, 2020

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ULTRAVATE Drug 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 Sun Pharm Industries and is included in three NDAs. There is one patent protecting this drug.

This drug has twenty-one patent family members in seventeen countries.

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

US ANDA Litigation and Generic Entry Outlook for Ultravate

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

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Drug patent expirations by year for ULTRAVATE
Drug Prices for ULTRAVATE

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Recent Clinical Trials for ULTRAVATE

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SponsorPhase
Valeant Pharmaceuticals International, Inc.Phase 2
Valeant Pharmaceuticals International, Inc.Phase 1
Therapeutics, Inc.Phase 2

See all ULTRAVATE clinical trials

Pharmacology for ULTRAVATE
Paragraph IV (Patent) Challenges for ULTRAVATE
Tradename Dosage Ingredient NDA Submissiondate
ULTRAVATE LOTION;TOPICAL halobetasol propionate 208183 2018-01-24

US Patents and Regulatory Information for ULTRAVATE

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   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Inc ULTRAVATE halobetasol propionate OINTMENT;TOPICAL 019968-001 Dec 17, 1990 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries ULTRAVATE halobetasol propionate LOTION;TOPICAL 208183-001 Nov 6, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm Industries ULTRAVATE halobetasol propionate LOTION;TOPICAL 208183-001 Nov 6, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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

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   Start Trial   Start Trial
Sun Pharm Inds Inc ULTRAVATE halobetasol propionate OINTMENT;TOPICAL 019968-001 Dec 17, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Merck

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