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Last Updated: April 18, 2024

FEMSTAT Drug Patent Profile


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Which patents cover Femstat, and when can generic versions of Femstat launch?

Femstat is a drug marketed by Roche Palo and Bayer and is included in three NDAs.

The generic ingredient in FEMSTAT is butoconazole nitrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the butoconazole nitrate profile page.

US Patents and Regulatory Information for FEMSTAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo FEMSTAT butoconazole nitrate CREAM;VAGINAL 019215-001 Nov 25, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche Palo FEMSTAT butoconazole nitrate SUPPOSITORY;VAGINAL 019359-001 Nov 25, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer FEMSTAT 3 butoconazole nitrate CREAM;VAGINAL 020421-001 Dec 21, 1995 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 FEMSTAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo FEMSTAT butoconazole nitrate CREAM;VAGINAL 019215-001 Nov 25, 1985 ⤷  Try a Trial ⤷  Try a Trial
Roche Palo FEMSTAT butoconazole nitrate SUPPOSITORY;VAGINAL 019359-001 Nov 25, 1985 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FEMSTAT

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

Country Patent Number Title Estimated Expiration
Germany 2633492 ⤷  Try a Trial
Malaysia 8100370 1-[2-(HALOPHENYLTHIO)-4-(P-CHLORO-OR-FLUOROPHENYL)-N-BUTYL]IMIDAZOLES ⤷  Try a Trial
United Kingdom 1522717 ⤷  Try a Trial
Japan S53135976 11**22HALOPHENYLTHIO**44*CHLOROOORR FLUOROPHENYL**NNBUTYL*IMIDAZOLE PROCESS FOR PREPARING SAME AND APPLICATION METHOD THEREOF ⤷  Try a Trial
Australia 1622276 ⤷  Try a Trial
France 2319348 ⤷  Try a Trial
Spain 450204 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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