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Last Updated: July 14, 2020

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Halobetasol propionate - Generic Drug Details

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What are the generic sources for halobetasol propionate and what is the scope of freedom to operate?

Halobetasol propionate is the generic ingredient in five branded drugs marketed by Mayne Pharma, Cosette, Fougera Pharms, Perrigo Israel, Taro, Sun Pharm Inds Inc, Bausch, Sun Pharm Industries, and Teligent Pharma Inc, and is included in seventeen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Halobetasol propionate has seventy-one patent family members in twenty-eight countries.

There are nine drug master file entries for halobetasol propionate. Eleven suppliers are listed for this compound.

Drug Prices for halobetasol propionate

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Recent Clinical Trials for halobetasol propionate

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SponsorPhase
Mayne Pharma International Pty LtdPhase 4
Bausch Health Americas, Inc.Phase 4
Sun Pharmaceutical Industries LimitedPhase 2

See all halobetasol propionate clinical trials

Pharmacology for halobetasol propionate
Paragraph IV (Patent) Challenges for HALOBETASOL PROPIONATE
Tradename Dosage Ingredient NDA Submissiondate
BRYHALI LOTION;TOPICAL halobetasol propionate 209355 2019-05-15
ULTRAVATE LOTION;TOPICAL halobetasol propionate 208183 2018-01-24

US Patents and Regulatory Information for halobetasol propionate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms HALOBETASOL PROPIONATE halobetasol propionate OINTMENT;TOPICAL 076903-001 Dec 16, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries ULTRAVATE halobetasol propionate LOTION;TOPICAL 208183-001 Nov 6, 2015 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Perrigo Israel HALOBETASOL PROPIONATE halobetasol propionate CREAM;TOPICAL 077123-001 Dec 16, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch BRYHALI halobetasol propionate LOTION;TOPICAL 209355-001 Nov 6, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 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 halobetasol propionate

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

Supplementary Protection Certificates for halobetasol propionate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 SPC/GB13/061 United Kingdom   Start Trial PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 474 Finland   Start Trial
1304992 PA2013025 Lithuania   Start Trial PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992 122013000081 Germany   Start Trial PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
McKesson
Johnson and Johnson
Mallinckrodt
Merck

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