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Last Updated: May 26, 2022

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, 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 thirty-seven 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 forty-five patent family members in forty countries.

There are twenty-four drug master file entries for fluticasone propionate. Sixty-six 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 AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 RX 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 208799-006 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 208798-004 Feb 20, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-001 Jan 27, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 RX 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
Padagis Israel FLUTICASONE PROPIONATE fluticasone propionate LOTION;TOPICAL 091553-001 Jul 30, 2013 AB RX No No See Plans and Pricing See Plans and Pricing 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 HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 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
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 See Plans and Pricing See Plans and Pricing
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 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
United Kingdom 2405800 Nasal devices See Plans and Pricing
China 105903113 用于吸入器的剂量计数器、吸入器及其轴 (Dose counters for inhalers, inhalers and shafts thereof) See Plans and Pricing
United Kingdom 2365778 Dose metering system for medicament inhaler See Plans and Pricing
Spain 2620803 See Plans and Pricing
Japan 2014221416 呼吸作動式ドライパウダー吸入器のための空気流アダプタ (AIRFLOW ADAPTOR FOR BREATH-ACTUATED DRY POWDER INHALER) See Plans and Pricing
Australia 8464301 See Plans and Pricing
Denmark 1180378 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
1519731 13C0067 France See Plans and Pricing 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 LUC00077 Luxembourg See Plans and Pricing 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
2506844 18C1022 France See Plans and Pricing 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
1305329 08C0014 France See Plans and Pricing PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844 2018C/022 Belgium See Plans and Pricing PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1519731 92269 Luxembourg See Plans and Pricing PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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