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Fluticasone propionate - Generic Drug Details
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, 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, and Optinose Us Inc, and is included in thirty-one NDAs. There are forty-seven 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 ninety patent family members in forty-seven 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: | 790 |
| US Patents: | 47 |
| Tradenames: | 16 |
| Applicants: | 17 |
| NDAs: | 31 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 85 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 288 |
| Patent Applications: | 6,998 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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-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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Optinose Us Inc | XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022-001 | Sep 18, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | Jan 27, 2017 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free 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 | 021433-003 | May 14, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Glaxo Grp Ltd | FLOVENT DISKUS 100 | fluticasone propionate | POWDER;INHALATION | 020833-002 | Sep 29, 2000 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Glaxosmithkline | FLOVENT | fluticasone propionate | POWDER;INHALATION | 020549-003 | Nov 7, 1997 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for fluticasone propionate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2014223544 | ➤ Try a Free Trial |
| Australia | 742913 | ➤ Try a Free Trial |
| Poland | 188988 | ➤ Try a Free Trial |
| Brazil | 9809554 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for fluticasone propionate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0067 | France | ➤ Try a Free 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 |
| C/GB08/026 | United Kingdom | ➤ Try a Free 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 |
| C0014 | France | ➤ Try a Free Trial | PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111 |
| 269 | Luxembourg | ➤ Try a Free Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 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 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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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