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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 patent protection?

Fluticasone propionate is the generic ingredient in eighteen branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Acp Nimble, Anda Repository, Nesher Pharms, Perrigo Israel, Glenmark Generics, Perrigo New York, Taro Pharm Inds, Teva Pharm, Glaxosmithkline Cons, Apotex, Apotex Inc, Hi Tech, Hi Tech Pharma, Hikma, Wockhardt Bio Ag, Optinose Us Inc, and Mylan, and is included in thirty-three NDAs. There are forty-two 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 eighty-five patent family members in forty-six countries.

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

Summary for fluticasone propionate

International Patents:	785
US Patents:	42
Tradenames:	18
Applicants:	20
NDAs:	33
Drug Master File Entries:	29
Suppliers / Packagers:	74
Bulk Api Vendors:	68
Clinical Trials:	299
Patent Applications:	6,691
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

See drug prices 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
Nicox Ophthalmics, Inc.	Phase 2
BECRO Ltd.	Phase 1
Respirent Pharmaceuticals Co Ltd.	Phase 1

See all fluticasone propionate clinical trials

Recent Litigation for fluticasone propionate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ADAMAS PHARMA, LLC v. SANDOZ INC.	2018-05-10
Glaxo Group Ltd. v. Teva Pharmaceuticals USA, Inc.	2017-03-31
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2015-09-08

See all fluticasone propionate litigation

PTAB Litigation

Petitioner	Date
Mylan Pharmaceuticals Inc.	2015-09-29

See all fluticasone propionate litigation

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

Paragraph IV (Patent) Challenges for FLUTICASONE PROPIONATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
FLOVENT HFA	AEROSOL, METERED;INHALATION	fluticasone propionate	021433	2016-12-23
CUTIVATE	LOTION;TOPICAL	fluticasone propionate	021152	2008-07-28

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
Hikma	FLUTICASONE PROPIONATE	fluticasone propionate	SPRAY, METERED;NASAL	076504-001	Feb 22, 2006	AB	RX	No	Yes
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		RX	Yes	No			Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	AB	RX	Yes	Yes
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017		DISCN	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	021433-001	May 14, 2004
Glaxosmithkline	FLONASE	fluticasone propionate	SPRAY, METERED;NASAL	020121-001	Oct 19, 1994
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	021433-002	May 14, 2004
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	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
Japan	2003535656
Japan	6403287
United Kingdom	2366208
Australia	8582501
Spain	2216800
Australia	2013223973
World Intellectual Property Organization (WIPO)	0200281

Supplementary Protection Certificates for fluticasone propionate

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