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Last Updated: July 14, 2020

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CUTIVATE Drug Profile


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

Cutivate is a drug marketed by Fougera Pharms and is included in three NDAs.

The generic ingredient in CUTIVATE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Drug patent expirations by year for CUTIVATE
Drug Prices for CUTIVATE

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Recent Clinical Trials for CUTIVATE

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

SponsorPhase
Fougera Pharmaceuticals Inc.Phase 4
Novartis PharmaceuticalsPhase 4
Children's Hospital of PhiladelphiaPhase 4

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Pharmacology for CUTIVATE
Paragraph IV (Patent) Challenges for CUTIVATE
Tradename Dosage Ingredient NDA Submissiondate
CUTIVATE LOTION;TOPICAL fluticasone propionate 021152 2008-07-28

US Patents and Regulatory Information for CUTIVATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms CUTIVATE fluticasone propionate CREAM;TOPICAL 019958-001 Dec 18, 1990 DISCN Yes No   Start Trial   Start Trial   Start Trial
Fougera Pharms CUTIVATE fluticasone propionate LOTION;TOPICAL 021152-001 Mar 31, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Fougera Pharms CUTIVATE fluticasone propionate OINTMENT;TOPICAL 019957-001 Dec 14, 1990 DISCN Yes No   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 CUTIVATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms CUTIVATE fluticasone propionate CREAM;TOPICAL 019958-001 Dec 18, 1990   Start Trial   Start Trial
Fougera Pharms CUTIVATE fluticasone propionate OINTMENT;TOPICAL 019957-001 Dec 14, 1990   Start Trial   Start Trial
Fougera Pharms CUTIVATE fluticasone propionate LOTION;TOPICAL 021152-001 Mar 31, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CUTIVATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 13C0067 France   Start Trial PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1519731 132013902182575 Italy   Start Trial PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
2506844 132018000000341 Italy   Start Trial PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1305329 SPC/GB08/026 United Kingdom   Start Trial PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111
2506844 18C1022 France   Start Trial PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
2506844 1890025-8 Sweden   Start Trial PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
2506844 LUC00077 Luxembourg   Start Trial PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Johnson and Johnson
McKinsey
AstraZeneca
Medtronic

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