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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 |
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 |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-002 | Jan 27, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | RX | Yes | Yes | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FLUTICASONE PROPIONATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1111201 | Start Trial |
| Hong Kong | 1222811 | Start Trial |
| Japan | 2015507990 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FLUTICASONE PROPIONATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1305329 | 08C0014 | France | Start Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.