FLUTICASONE PROPIONATE - Generic Drug Details

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What are the generic 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 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 ninety-four patent family members in forty countries.

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

Summary for FLUTICASONE PROPIONATE

International Patents:	794
US Patents:	43
Tradenames:	20
Applicants:	19
NDAs:	35
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	68
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	360
Patent Applications:	6,953
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

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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

Sponsor	Phase
Emory University	Phase 3
Sanofi	Phase 3
John Harris	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	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
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
Mylan	WIXELA INHUB	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208891-003	Jan 30, 2019	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
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
>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
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
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	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

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	2453841	Nasal delivery device	See Plans and Pricing
China	104428025	Nasal delivery devices	See Plans and Pricing
European Patent Office	2197525	DISPOSITIFS D'ADMINISTRATION NASALE (NASAL DELIVERY DEVICES)	See Plans and Pricing
>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
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
1305329	SPC/GB08/026	United Kingdom	See Plans and Pricing	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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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