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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, Perrigo Israel, Glenmark Generics, Perrigo New York, Taro Pharm Inds, Teva Pharm, Glaxosmithkline Cons, Akorn, Apotex, Apotex Inc, Hikma, Wockhardt Bio Ag, Optinose Us Inc, and Mylan, and is included in thirty-four NDAs. There are forty-four 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.

Summary for fluticasone propionate

International Patents:	762
US Patents:	44
Tradenames:	20
Applicants:	19
NDAs:	34
Drug Master File Entries:	29
Suppliers / Packagers:	70
Bulk Api Vendors:	77
Clinical Trials:	314
Patent Applications:	7,164
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fluticasone propionate
Drug Sales Revenues:	Drug sales revenues for fluticasone propionate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone propionate
DailyMed Link:	fluticasone propionate at DailyMed

See drug prices for fluticasone propionate

See drug sales revenues for fluticasone propionate

Recent Clinical Trials for fluticasone propionate

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 3
PARZIBUT Gilles	Phase 4
St. Paul's Sinus Centre	Phase 4

See all fluticasone propionate clinical trials

Pharmacology for fluticasone propionate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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 DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020		RX	Yes	No			Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		RX	Yes	No			Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		RX	Yes	No			Y
Anda Repository	FLUTICASONE PROPIONATE	fluticasone propionate	CREAM;TOPICAL	076633-001	May 14, 2004		DISCN	No	No
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017		DISCN	Yes	No			Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		RX	Yes	No			Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No			Y

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
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	May 14, 2004
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000

International Patents for fluticasone propionate

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	201690642
Portugal	2189176
Austria	487506
European Patent Office	3185938
China	102655902
Canada	2407057
South Africa	201509290

Supplementary Protection Certificates for fluticasone propionate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	18C1022	France		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
2506844	2018C/022	Belgium		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
2506844	132018000000341	Italy		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	SPC/GB08/026	United Kingdom		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
1519731	132013902182575	Italy		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	1890025-8	Sweden		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
2506844	LUC00077	Luxembourg		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