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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 nineteen 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, Apotex, Apotex Inc, Hi Tech, Hi Tech Pharma, Hikma, Wockhardt Bio Ag, Optinose Us Inc, and Mylan, and is included in thirty-three NDAs. There are forty-three 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 fifty-six patent family members in forty countries.

There are twenty-nine drug master file entries for fluticasone propionate. Seventy-three suppliers are listed for this compound.

Summary for fluticasone propionate

International Patents:	756
US Patents:	43
Tradenames:	19
Applicants:	20
NDAs:	33
Drug Master File Entries:	29
Suppliers / Packagers:	73
Bulk Api Vendors:	69
Clinical Trials:	308
Patent Applications:	5,316
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
St. Paul's Sinus Centre	Phase 4
European Research Council	Phase 4
Stanford University	Phase 2/Phase 3

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
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004		RX	Yes	Yes					Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		RX	Yes	No			Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		RX	Yes	No			Y
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006		RX	Yes	Yes					Y
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-001	Nov 7, 1997		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	208798-006	Feb 20, 2020		RX	Yes	Yes			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
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	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
Peru	20020075
Argentina	028747
China	105597205
Denmark	2514467
Turkey	200102563
Australia	2002255224
Hong Kong	1173954

Supplementary Protection Certificates for fluticasone propionate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731	13C0067	France		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
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	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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
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