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Last Updated: October 27, 2020

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Fluticasone propionate - Generic Drug Details

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

Fluticasone propionate is the generic ingredient in nineteen branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Anda Repository, Cosette, Nesher Pharms, Perrigo Israel, Glenmark Generics, Perrigo New York, Taro Pharm Inds, Teva Pharm, Glaxosmithkline Cons, Apotex, Apotex Inc, Hi Tech, Hi Tech Pharma, Hikma, Wockhardt Bio Ag, Optinose Us Inc, and Mylan, and is included in thirty-three NDAs. There are forty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate has seven hundred and fifty-six patent family members in forty countries.

There are twenty-nine drug master file entries for fluticasone propionate. Seventy-three suppliers are listed for this compound.

Drug Prices for fluticasone propionate

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Drug Sales Revenue Trends for fluticasone propionate

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Recent Clinical Trials for fluticasone propionate

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

SponsorPhase
St. Paul's Sinus CentrePhase 4
European Research CouncilPhase 4
Stanford UniversityPhase 2/Phase 3

See all fluticasone propionate clinical trials

Pharmacology for fluticasone propionate
Paragraph IV (Patent) Challenges for FLUTICASONE PROPIONATE
Tradename Dosage Ingredient NDA Submissiondate
FLOVENT HFA AEROSOL, METERED;INHALATION fluticasone propionate 021433 2016-12-23
CUTIVATE LOTION;TOPICAL fluticasone propionate 021152 2008-07-28

US Patents and Regulatory Information for fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-004 Feb 20, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-006 Jul 12, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-003 Jun 8, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline FLOVENT fluticasone propionate POWDER;INHALATION 020549-001 Nov 7, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-001 Jan 27, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 RX Yes Yes   Start Trial   Start Trial Y   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 fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT DISKUS 100 fluticasone propionate POWDER;INHALATION 020833-002 Sep 29, 2000   Start Trial   Start Trial
Optinose Us Inc XHANCE fluticasone propionate SPRAY, METERED;NASAL 209022-001 Sep 18, 2017   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT DISKUS 50 fluticasone propionate POWDER;INHALATION 020833-001 Sep 29, 2000   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT DISKUS 250 fluticasone propionate POWDER;INHALATION 020833-003 Sep 29, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fluticasone propionate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1305329 08C0014 France   Start Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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 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
1519731 92269 Luxembourg   Start Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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