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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 fluticasone propionate patent protection?

Fluticasone propionate is the generic ingredient in sixteen branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, G And W Labs, Nesher Pharms, Perrigo New York, Tolmar, 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-one 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-four patent family members in forty-six countries.

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

Summary for fluticasone propionate

International Patents:	764
US Patents:	41
Tradenames:	16
Applicants:	17
NDAs:	31
Drug Master File Entries:	26
Suppliers / Packagers:	83
Bulk Api Vendors:	66
Clinical Trials:	277
Patent Applications:	6,957
Formulation / Manufacturing:	see details
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
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006		RX	Yes	Yes					Y
Apotex Inc	FLUTICASONE PROPIONATE	fluticasone propionate	SPRAY, METERED;NASAL	208150-001	Feb 29, 2016		OTC	No	No
Nesher Pharms	FLUTICASONE PROPIONATE	fluticasone propionate	CREAM;TOPICAL	076865-001	Sep 10, 2004		DISCN	No	No

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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	021433-003	May 14, 2004
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000
Glaxo Grp Ltd	FLOVENT DISKUS 250	fluticasone propionate	POWDER;INHALATION	020833-003	Sep 29, 2000

Non-Orange Book US Patents for fluticasone propionate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,191,777	Medicament dispenser
7,661,423	Device housing for an aerosol container
7,819,116	Medicament dispenser
6,142,339	Aerosol dispensing device

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International Patents for fluticasone propionate

Country	Document Number	Estimated Expiration
Canada	2779347
China	1265601
European Patent Office	3124067
South Africa	200209369

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
C0014	France		PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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