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Last Updated: October 23, 2021

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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 twenty branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Anda Repository, Cosette, Nesher Pharms, Padagis Israel, Glenmark Generics, Taro Pharm Inds, Teva Pharm, Glaxosmithkline Cons, Akorn, Apotex, Apotex Inc, Hikma Pharms, Wockhardt Bio Ag, Optinose Us Inc, and Mylan, and is included in thirty-four NDAs. There are fifty-six 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 sixty-two patent family members in forty countries.

There are twenty-nine drug master file entries for fluticasone propionate. Seventy 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
University of Medicine and Pharmacy at Ho Chi Minh CityPhase 2/Phase 3
Assistance Publique - Hôpitaux de ParisPhase 3
PARZIBUT GillesPhase 4

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
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-003 Jan 27, 2017 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-004 Feb 20, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-004 Jul 12, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Fougera Pharms FLUTICASONE PROPIONATE fluticasone propionate OINTMENT;TOPICAL 076300-001 May 14, 2004 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-002 Jan 27, 2017 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 021433-002 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT DISKUS 50 fluticasone propionate POWDER;INHALATION 020833-001 Sep 29, 2000 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-001 Jan 27, 2017 ⤷  Try it Free ⤷  Try it Free
>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
2506844 1890025-8 Sweden ⤷  Try it Free 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
1519731 92269 Luxembourg ⤷  Try it Free PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731 132013902182575 Italy ⤷  Try it Free 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 LUC00077 Luxembourg ⤷  Try it Free 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
1519731 13C0067 France ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Johnson and Johnson
Merck
Mallinckrodt
Moodys

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