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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 fluticasone propionate freedom to operate?

Fluticasone propionate is the generic ingredient in sixteen branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Anda Repository, G And W Labs, Nesher Pharms, Perrigo New York, Glenmark Generics, Perrigo Israel, Taro Pharm Inds, Teva Pharm, Glaxosmithkline Cons, Apotex Inc, Hi Tech Pharma, West-ward Pharms Int, Wockhardt Bio Ag, and Optinose Us Inc, and is included in thirty-one 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.

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

Summary for fluticasone propionate

US Patents:	43
Tradenames:	16
Applicants:	17
NDAs:	31
Drug Master File Entries:	28
Suppliers / Packagers:	84
Bulk Api Vendors:	65
Clinical Trials:	285
Patent Applications:	6,976
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for fluticasone propionate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone propionate
DailyMed Link:	fluticasone propionate at DailyMed

Pharmacology for fluticasone propionate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Synonyms for fluticasone propionate

(1R,2S,8S,10S,11S,13R,14R,15S,17S)-1,8-difluoro-14-{[(fluoromethyl)sulfanyl]carbonyl}-17-hydroxy-2,13,15-trimethyl-5-oxotetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-3,6-dien-14-yl propanoate

(6?,11?,16?,17?)-6,9-Difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid fluoromethyl ester

(6alpha,11beta,16alpha,17alpha)-6,9-Difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-(fluoromethyl) ester

[(6S,8S,9R,10S,11S,13S,14S,16R,17R)-6,9-difluoro-17-(fluoromethylsulfanylcarbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate

474F142

6alpha,9-difluoro-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-11beta-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17alpha-yl propanoate

80474-14-2

AB00513992

AB00513992_08

AB00513992-06

AB1010912

AC-457

AC1L9FLD

AJ-47435

AKOS015895220

AN-584/43505443

Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-, (6alpha,11beta,16alpha,17alpha)-S-(fluoromethyl) ester

Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-, S-(fluoromethyl) ester, (6-alpha,11-beta,16-alpha,17-alpha)-

ArmonAir RespiClick

ArmonAir RespiClickTM

Asmatil

atemur

Axotide

BC216013

BDBM50354849

BIF0710

BPBio1_001203

BR-72799

BRD-K62310379-001-03-0

Brethal

BSPBio_001093

C25H31F3O5S

CCG-100981

CCI 18781

CCI-18781

CHEBI:31441

CHEMBL1473

CS-1986

Cultivate

Cutivate

Cutivate (TN)

D01708

DB00588

Flixonase

Flixonase Nasal Spray

Flixotide

Flixotide Disk

Flixotide Disks

Flixotide Inhaler

Flonase

Flonase (TN)

Flonase Allergy Relief

Flonase Aq

Flovent

Flovent (TN)

Flovent Diskus

Flovent Diskus 100

Flovent Diskus 250

Flovent Diskus 50

Flovent HFA

Flovent-hfa

Fluinol

Flunase

Flusonal

Fluspiral

Fluticasone (propionate)

fluticasone 17-propionate

Fluticasone Impurity B

Fluticasone propionate (Flonase, Veramyst)

Fluticasone propionate (JAN/USAN)

Fluticasone propionate [USAN:USP]

Fluticasone propionate [USAN]

Fluticasone propionate for impurity C identification, EuropePharmacopoeia (EP) Reference Standard

Fluticasone propionate for impurity G identification, EuropePharmacopoeia (EP) Reference Standard

Fluticasone propionate, >=98% (HPLC), powder

Fluticasone propionate, European Pharmacopoeia (EP) Reference Standard

Fluticasone Propionate, pharmaceutical secondary standard; traceable to USP, PhEur, BP

Fluticasone propionate, United States Pharmacopeia (USP) Reference Standard

fluticasone proprionate

Fluticasonpropionat Allen

Flutide

Flutivate

Fluxonal

FN-25

FT-0082893

GTPL7080

HMS1571G15

HMS2051N19

HMS2098G15

HY-B0154

Inalacor

KS-1173

LS-19323

MFCD00866007

MLS001424085

MolPort-003-847-468

NC00231

NCGC00179308-01

NCGC00179308-05

O2GMZ0LF5W

Prestwick0_000997

Prestwick1_000997

Prestwick2_000997

Prestwick3_000997

Q-101393

Rinosone

RS0009

S-(Fluoromethyl) 6alpha,9-difluoro-11beta,17-dihydroxy-16alpha-methyl-3-oxoandrosta-1,4-diene-17beta-carbothioate, 17-propionate

S-(fluoromethyl)-6,9-difluoro-11,17-dihydroxy-16-methyl-3-oxoandrosta-1,4-diene-17-carbothioate,17-propionate

s1992

SBB071021

SC-19333

SCHEMBL4068

Skyron

SMR000469159

SPBio_002984

ST2407016

Trialona

Ubizol

UNII-O2GMZ0LF5W

WMWTYOKRWGGJOA-CENSZEJFSA-N

Xhance

ZINC3920027

Zoflut

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			Y
Anda Repository	FLUTICASONE PROPIONATE	fluticasone propionate	CREAM;TOPICAL	076633-001	May 14, 2004	AB	RX	No	No
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		RX	Yes	Yes			Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017		RX	Yes	No			Y
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	May 14, 2004		RX	Yes	Yes
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		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 DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000
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
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017
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	021433-003	May 14, 2004

International Patents for fluticasone propionate

Country	Document Number	Estimated Expiration
United Kingdom	0311191
Australia	709052
Taiwan	I224513
Canada	2635426
Portugal	1667627
United Kingdom	0316033

Supplementary Protection Certificates for fluticasone propionate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0067	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
C/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
269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
C0014	France		PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111