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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 seventeen 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, Optinose Us Inc, and Mylan Pharms Inc, and is included in thirty-two NDAs. There are thirty-eight 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 fifteen patent family members in forty-six countries.

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

Summary for fluticasone propionate

International Patents:	715
US Patents:	38
Tradenames:	17
Applicants:	18
NDAs:	32
Drug Master File Entries:	29
Suppliers / Packagers:	85
Bulk Api Vendors:	70
Clinical Trials:	295
Patent Applications:	6,632
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

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 Rotadisk

Flovent-hfa

Fluinol

Flunase

Flusonal

Fluspiral

Fluticasone (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; Certified Reference Material

Fluticasone propionate, United States Pharmacopeia (USP) Reference Standard

Fluticasonpropionat Allen

Flutide

Flutivate

Fluxonal

FN-25

FT-0082893

GTPL7080

HMS1571G15

HMS2051N19

HMS2098G15

HMS3715G15

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

SC-19333

SCHEMBL4068

Skyron

SMR000469159

SPBio_002984

SR-01000763355

SR-01000763355-3

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	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017		RX	Yes	No			Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No			Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No			Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes			Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017		RX	Yes	No			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 HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004
Glaxo Grp Ltd	FLOVENT DISKUS 100	fluticasone propionate	POWDER;INHALATION	020833-002	Sep 29, 2000
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	021433-002	May 14, 2004
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004

International Patents for fluticasone propionate

Country	Patent Number	Estimated Expiration
China	104784790
Portugal	1516283
Mexico	339742
Uruguay	26792
South Africa	201307991
South Korea	101618421

Supplementary Protection Certificates for fluticasone propionate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	2018C/022	Belgium		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
2506844	LUC00077	Luxembourg		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
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