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Last Updated: March 1, 2024

Fluticasone propionate - Generic Drug Details


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What are the generic drug sources for fluticasone propionate and what is the scope of patent protection?

Fluticasone propionate is the generic ingredient in twenty branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Cosette, Encube, Nesher Pharms, Padagis Israel, Glenmark Generics, Bright, Taro Pharm Inds, Teva Pharm, Glaxosmithkline Cons, Apotex, Apotex Inc, Chartwell Rx, Hikma, Optinose Us Inc, Teva Pharms Usa, and Mylan, and is included in thirty-six NDAs. There are forty-eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate has eight hundred and fifty-two patent family members in forty countries.

There are twenty-four drug master file entries for fluticasone propionate. Seventy-nine 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
Eurofarma Laboratorios S.A.Phase 3
Emory UniversityPhase 3
SanofiPhase 3

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Pharmacology for fluticasone propionate
Paragraph IV (Patent) Challenges for FLUTICASONE PROPIONATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FLOVENT HFA Inhalation Aerosol fluticasone propionate 0.22 mcg/inh 021433 1 2021-10-29
FLOVENT HFA Inhalation Aerosol fluticasone propionate 0.11 mcg/inh 021433 1 2016-12-23
CUTIVATE Lotion fluticasone propionate 0.05% 021152 1 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 DIGIHALER fluticasone propionate POWDER;INHALATION 208798-008 Apr 8, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-008 Apr 8, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-006 Jul 12, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-004 Feb 20, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd FLOVENT DISKUS 50 fluticasone propionate POWDER;INHALATION 020833-001 Sep 29, 2000 ⤷  Try a Trial ⤷  Try a Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-005 Feb 20, 2020 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT DISKUS 50 fluticasone propionate POWDER;INHALATION 020833-001 Sep 29, 2000 ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 ⤷  Try a Trial ⤷  Try a 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
1519731 13C0067 France ⤷  Try a 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
2506844 1890025-8 Sweden ⤷  Try a 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 08C0014 France ⤷  Try a Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731 132013902182575 Italy ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.