FLOVENT HFA Drug Patent Profile
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Which patents cover Flovent Hfa, and when can generic versions of Flovent Hfa launch?
Flovent Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.
This drug has twenty-nine patent family members in seventeen countries.
The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Flovent Hfa
A generic version of FLOVENT HFA was approved as fluticasone propionate by FOUGERA PHARMS on May 14th, 2004.
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Summary for FLOVENT HFA
| International Patents: | 29 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 38 |
| Patent Applications: | 5,456 |
| 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 |
|---|---|
| Glenmark Pharmaceuticals Ltd. India | Phase 3 |
| Children's Hospital Medical Center, Cincinnati | Phase 2 |
| Becro Ltd. | Phase 1 |
Pharmacology for FLOVENT HFA
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for FLOVENT HFA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FLOVENT HFA | Inhalation Aerosol | fluticasone propionate | 0.22 mg/inh | 021433 | 1 | 2021-10-29 |
| FLOVENT HFA | Inhalation Aerosol | fluticasone propionate | 0.11 mg/inh | 021433 | 1 | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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
| 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 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FLOVENT HFA
See the table below for patents covering FLOVENT HFA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2099415 | ⤷ Sign Up | |
| United Kingdom | 9126378 | ⤷ Sign Up | |
| Austria | 274952 | ⤷ Sign Up | |
| Japan | H0776380 | AEROSOL CONTAINER AND ITS USAGE | ⤷ Sign Up |
| Japan | 2003512157 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FLOVENT HFA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2506844 | 18C1022 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117 |
| 2506844 | 132018000000341 | Italy | ⤷ Sign Up | 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 | 2018C/022 | Belgium | ⤷ Sign Up | 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 | 132013902182575 | Italy | ⤷ Sign Up | 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 |
| 1305329 | SPC/GB08/026 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116 |
| >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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