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Fluticasone propionate - Generic Drug Details
What are the generic drug sources for fluticasone propionate and what is the scope of patent protection?
Fluticasone propionate
is the generic ingredient in nineteen 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-three 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 forty-eight patent family members in forty countries.
There are twenty-nine drug master file entries for fluticasone propionate. Seventy-two suppliers are listed for this compound.
Summary for fluticasone propionate
| International Patents: | 748 |
| US Patents: | 43 |
| Tradenames: | 19 |
| Applicants: | 20 |
| NDAs: | 33 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 72 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 302 |
| Patent Applications: | 6,828 |
| 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 |
Recent Clinical Trials for fluticasone propionate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stanford University | Phase 2/Phase 3 |
| Adare Pharmaceuticals, Inc. | Phase 3 |
| Nicox Ophthalmics, Inc. | Phase 2 |
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 |
|---|---|
| 2018-10-26 | |
| Mylan Pharmaceuticals Inc. | 2015-09-29 |
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 |
| 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 |
| 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 |
| HMS3413A19 |
| HMS3677A19 |
| HMS3715G15 |
| HY-B0154 |
| Inalacor |
| KS-1173 |
| LS-19323 |
| MFCD00866007 |
| MLS001424085 |
| NC00231 |
| NCGC00179308-01 |
| NCGC00179308-05 |
| O2GMZ0LF5W |
| PF-00241939 |
| Prestwick0_000997 |
| Prestwick1_000997 |
| Prestwick2_000997 |
| Prestwick3_000997 |
| Q-101393 |
| Q8564098 |
| Rinosone |
| S-(Fluoromethyl) 6alpha,9-difluoro-11beta,17-dihydroxy-16alpha-methyl-3-oxoandrosta-1,4-diene-17beta-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 DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-004 | Jul 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-005 | Feb 20, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-004 | Feb 20, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| 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 | |||
| Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-003 | Jan 27, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-005 | Feb 20, 2020 | RX | 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 DISKUS 100 | fluticasone propionate | POWDER;INHALATION | 020833-002 | Sep 29, 2000 | Start Trial | Start Trial |
| Optinose Us Inc | XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022-001 | Sep 18, 2017 | 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 | 021433-001 | 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 | 021433-001 | May 14, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluticasone propionate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2317916 | Start Trial |
| China | 101918061 | Start Trial |
| Portugal | 2514467 | Start Trial |
| Eurasian Patent Organization | 201300234 | Start Trial |
| Cyprus | 1116358 | Start Trial |
| Australia | 709052 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for fluticasone propionate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 132018000000341 | Italy | Start Trial | PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): 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 |
| 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 |
| 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 |
| 1519731 | 92269 | Luxembourg | Start Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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