DrugPatentWatch Database Preview
FLOVENT Drug Profile
» See Plans and Pricing
Which patents cover Flovent, and what generic alternatives are available?
Flovent is a drug marketed by Glaxosmithkline and Glaxo Grp Ltd and is included in four NDAs. There are four patents protecting this drug.
The generic ingredient in FLOVENT is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy 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
A generic version of FLOVENT was approved as fluticasone propionate by FOUGERA PHARMS on May 14th, 2004.
Summary for FLOVENT
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 4 |
| Bulk Api Vendors: | 77 |
| Clinical Trials: | 29 |
| Patent Applications: | 4,311 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FLOVENT |
| Drug Sales Revenues: | Drug sales revenues for FLOVENT |
| DailyMed Link: | FLOVENT at DailyMed |
Recent Clinical Trials for FLOVENT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Respirent Pharmaceuticals Co Ltd. | Phase 3 |
| BECRO Ltd. | Phase 3 |
| Teva Pharmaceuticals USA | Phase 3 |
US Patents and Regulatory Information for FLOVENT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | FLOVENT | fluticasone propionate | AEROSOL, METERED;INHALATION | 020548-001 | Mar 27, 1996 | DISCN | No | No | Start Trial | Start Trial | 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 DISKUS 100 | fluticasone propionate | POWDER;INHALATION | 020833-002 | Sep 29, 2000 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Glaxosmithkline | FLOVENT | fluticasone propionate | POWDER;INHALATION | 020549-001 | Nov 7, 1997 | DISCN | No | No | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | FLOVENT | fluticasone propionate | AEROSOL, METERED;INHALATION | 020548-001 | Mar 27, 1996 | Start Trial | Start Trial |
| Glaxosmithkline | FLOVENT | fluticasone propionate | POWDER;INHALATION | 020549-001 | Nov 7, 1997 | Start Trial | Start Trial |
| Glaxosmithkline | FLOVENT | fluticasone propionate | POWDER;INHALATION | 020549-002 | Nov 7, 1997 | Start Trial | Start Trial |
| Glaxosmithkline | FLOVENT | fluticasone propionate | POWDER;INHALATION | 020549-003 | Nov 7, 1997 | Start Trial | Start Trial |
| Glaxosmithkline | FLOVENT | fluticasone propionate | AEROSOL, METERED;INHALATION | 020548-002 | Mar 27, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FLOVENT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 72502 | Start Trial |
| Belgium | 887518 | Start Trial |
| Austria | A67481 | Start Trial |
| Czech Republic | 281275 | Start Trial |
| Spain | 8305379 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FLOVENT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1519731 | 132013902182575 | Italy | Start Trial | PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527 |
| 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 |
| 1519731 | 92269 | Luxembourg | Start Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
