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Last Updated: April 28, 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, Haleon Us Holdings, Apotex, Apotex Inc, Chartwell Rx, Hikma, Optinose Us Inc, Teva Pharms Usa, and Mylan, and is included in thirty-six NDAs. There are forty-five 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-eight patent family members in thirty-nine countries.

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

Summary for fluticasone propionate

International Patents:	758
US Patents:	45
Tradenames:	20
Applicants:	19
NDAs:	36
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	78
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	363
Patent Applications:	7,612
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
What excipients (inactive ingredients) are in fluticasone propionate?	fluticasone propionate excipients list
DailyMed Link:	fluticasone propionate at DailyMed

See drug prices for fluticasone propionate

Drug Sales Revenue Trends 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
Eurofarma Laboratorios S.A.	Phase 3
Sanofi	Phase 3
Emory University	Phase 3

See all fluticasone propionate clinical trials

Pharmacology for fluticasone propionate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	FLOVENT	fluticasone propionate	AEROSOL, METERED;INHALATION	020548-003	Mar 27, 1996		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	May 14, 2004		RX	Yes	Yes	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	CUTIVATE	fluticasone propionate	OINTMENT;TOPICAL	019957-001	Dec 14, 1990	⤷ Try a Trial	⤷ Try a Trial
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	⤷ Try a Trial	⤷ Try a Trial
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluticasone propionate

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Country	Patent Number	Title	Estimated Expiration
Argentina	102055	MÓDULO DE ASISTENCIA PARA EL USO CORRECTO DE UN INHALADOR	⤷ Try a Trial
European Patent Office	3546000	ADMINISTRATION NASALE (NASAL ADMINISTRATION)	⤷ Try a Trial
Spain	2436496		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fluticasone propionate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	92269	Luxembourg	⤷ Try a Trial	PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844	LUC00077	Luxembourg	⤷ Try a Trial	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
1305329	SPC/GB08/026	United Kingdom	⤷ Try a Trial	PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
>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.