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Last Updated: January 20, 2020

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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.

Drug Prices for fluticasone propionate

See drug prices for fluticasone propionate

Drug Sales Revenue Trends for fluticasone propionate

See drug sales revenues for fluticasone propionate

Recent Clinical Trials for fluticasone propionate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
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 NameDate
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
PetitionerDate
Mylan Pharmaceuticals Inc.2015-09-29

See all fluticasone propionate litigation

Pharmacology for fluticasone propionate
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   Start Trial   Start Trial Y   Start Trial
Hikma FLUTICASONE PROPIONATE fluticasone propionate SPRAY, METERED;NASAL 076504-001 Feb 22, 2006 AB RX No Yes   Start Trial   Start Trial   Start Trial
Optinose Us Inc XHANCE fluticasone propionate SPRAY, METERED;NASAL 209022-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-006 Jul 12, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Optinose Us Inc XHANCE fluticasone propionate SPRAY, METERED;NASAL 209022-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-001 Aug 24, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-001 Jan 27, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>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

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   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004   Start Trial   Start Trial
Glaxosmithkline FLONASE fluticasone propionate SPRAY, METERED;NASAL 020121-001 Oct 19, 1994   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fluticasone propionate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 92269 Luxembourg   Start Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844 1890025-8 Sweden   Start Trial 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   Start Trial 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   Start Trial 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   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Colorcon
AstraZeneca
McKesson
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.