Fluticasone propionate - Generic Drug Details
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What are the generic sources for fluticasone propionate and what is the scope of freedom to operate?
Fluticasone propionate
is the generic ingredient in twenty branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Cosette, Encube, Nesher Pharms, Padagis Israel, Glenmark Generics, Bright, Taro Pharm Inds, Teva Pharm, Haleon Us Holdings, Apotex, Apotex Inc, Chartwell Rx, Hikma, Optinose Us Inc, Teva Pharms Usa, and Mylan, and is included in thirty-six NDAs. There are forty-five 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 fifty-eight patent family members in thirty-nine countries.
There are twenty-four drug master file entries for fluticasone propionate. Seventy-eight suppliers are listed for this compound.
Summary for fluticasone propionate
International Patents: | 758 |
US Patents: | 45 |
Tradenames: | 20 |
Applicants: | 19 |
NDAs: | 36 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 78 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 363 |
Patent Applications: | 7,612 |
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 |
What excipients (inactive ingredients) are in fluticasone propionate? | fluticasone propionate excipients list |
DailyMed Link: | fluticasone propionate at DailyMed |
Recent Clinical Trials for fluticasone propionate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eurofarma Laboratorios S.A. | Phase 3 |
Emory University | Phase 3 |
Sanofi | Phase 3 |
Pharmacology for fluticasone propionate
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for FLUTICASONE PROPIONATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FLOVENT HFA | Inhalation Aerosol | fluticasone propionate | 0.22 mcg/inh | 021433 | 1 | 2021-10-29 |
FLOVENT HFA | Inhalation Aerosol | fluticasone propionate | 0.11 mcg/inh | 021433 | 1 | 2016-12-23 |
CUTIVATE | Lotion | fluticasone propionate | 0.05% | 021152 | 1 | 2008-07-28 |
US Patents and Regulatory Information for fluticasone propionate
Expired US Patents for fluticasone propionate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-002 | Jan 27, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | FLOVENT DISKUS 50 | fluticasone propionate | POWDER;INHALATION | 020833-001 | Sep 29, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-001 | Jan 27, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluticasone propionate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2364009 | DISPOSITIF D'ADMINISTRATION NASALE (NASAL DELIVERY DEVICE) | ⤷ Try a Trial |
European Patent Office | 2987523 | COMPTEURS DE DOSES POUR INHALATEURS (DOSE COUNTERS FOR INHALERS) | ⤷ Try a Trial |
Australia | 2013223973 | Nasal delivery devices | ⤷ Try a Trial |
Australia | 2021291033 | Inhaler system | ⤷ Try a Trial |
Japan | 6243360 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fluticasone propionate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2506844 | 2018C/022 | Belgium | ⤷ Try a 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 | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
1305329 | SPC/GB08/026 | United Kingdom | ⤷ Try a Trial | 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 |
2506844 | LUC00077 | Luxembourg | ⤷ Try a 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 | 132013902182575 | Italy | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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