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Last Updated: September 30, 2022

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, Wockhardt Bio Ag, Optinose Us Inc, Teva Pharms Usa, and Mylan, and is included in thirty-five NDAs. There are forty-one 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 ninety patent family members in forty countries.

There are twenty-four drug master file entries for fluticasone propionate. Sixty-five 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
Glenmark Pharmaceuticals Ltd. IndiaPhase 3
University of South FloridaPhase 4
Andover Research Eye InstitutePhase 4

See all FLUTICASONE PROPIONATE clinical trials

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-003 Jan 27, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-004 Jul 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-005 Feb 20, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd FLOVENT DISKUS 100 fluticasone propionate POWDER;INHALATION 020833-002 Sep 29, 2000 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 See Plans and Pricing See Plans and Pricing
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-003 Jan 27, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FLUTICASONE PROPIONATE

Country Patent Number Title Estimated Expiration
European Patent Office 3761318 DISPOSITIF D'ADMINISTRATION DE MÉDICAMENT COMPRENANT UN SYSTÈME ÉLECTRONIQUE ET UNE GESTION DE L'ALIMENTATION (DRUG DELIVERY DEVICE WITH ELECTRONICS AND POWER MANAGEMENT) See Plans and Pricing
United Kingdom 2381460 Nasal delivery device See Plans and Pricing
Japan 5778422 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011054527 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLUTICASONE PROPIONATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 SPC/GB18/020 United Kingdom See Plans and Pricing PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1519731 132013902182575 Italy See Plans and Pricing 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 See Plans and Pricing 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 08C0014 France See Plans and Pricing PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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