DrugPatentWatch Database Preview
FLOVENT HFA Drug Profile
Which patents cover Flovent Hfa, and what generic alternatives are available?
Flovent Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are five patents protecting this drug.
This drug has one hundred and fifty patent family members in thirty-six countries.
The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
US ANDA Litigation and Generic Entry Outlook for Flovent Hfa
A generic version of FLOVENT HFA was approved as fluticasone propionate by ANDA REPOSITORY on January 28th, 2020.
Summary for FLOVENT HFA
| International Patents: | 150 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 68 |
| Clinical Trials: | 28 |
| Patent Applications: | 6,623 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FLOVENT HFA |
| Drug Sales Revenues: | Drug sales revenues for FLOVENT HFA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FLOVENT HFA |
| DailyMed Link: | FLOVENT HFA at DailyMed |
See drug prices for FLOVENT HFA
Recent Clinical Trials for FLOVENT HFA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Teva Pharmaceuticals USA | Phase 3 |
| Actavis Inc. | Phase 3 |
| University of Pittsburgh | Phase 1 |
Recent Litigation for FLOVENT HFA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Glaxo Group Ltd. v. Teva Pharmaceuticals USA, Inc. | 2017-03-31 |
See all FLOVENT HFA litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2015-09-29 |
Pharmacology for FLOVENT HFA
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Synonyms for FLOVENT HFA
| (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 Rotadisk |
| Flovent-hfa |
| Fluinol |
| Flunase |
| Flusonal |
| Fluspiral |
| Fluticasone (propionate) |
| Fluticasone Impurity B |
| FLUTICASONE PROPIONATE |
| 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 FLOVENT HFA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FLOVENT HFA | AEROSOL, METERED;INHALATION | fluticasone propionate | 021433 | 2016-12-23 |
US Patents and Regulatory Information for FLOVENT HFA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | 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 FLOVENT HFA
International Patents for FLOVENT HFA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1108995 | Start Trial |
| Yugoslavia | 49329 | Start Trial |
| European Patent Office | 1516283 | Start Trial |
| Denmark | 0617610 | Start Trial |
| Australia | 7918100 | Start Trial |
| Germany | 60008402 | Start Trial |
| European Patent Office | 1145987 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FLOVENT HFA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 92269 | Luxembourg | Start Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 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 |
| 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 | 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 | 08C0014 | France | Start Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
