FLUTICASONE PROPIONATE - Generic Drug Details
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What are the generic sources for fluticasone propionate and what is the scope of patent protection?
Fluticasone propionate
is the generic ingredient in twenty branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Anda Repository, Cosette, Nesher Pharms, Padagis Israel, Glenmark Generics, Taro Pharm Inds, Teva Pharm, Glaxosmithkline Cons, Akorn, Apotex, Apotex Inc, Hikma, Wockhardt Bio Ag, Optinose Us Inc, Teva Pharms Usa, and Mylan, and is included in thirty-five NDAs. There are forty-three 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 ninety-four patent family members in forty countries.
There are twenty-four drug master file entries for fluticasone propionate. Sixty-eight suppliers are listed for this compound.
Summary for FLUTICASONE PROPIONATE
International Patents: | 794 |
US Patents: | 43 |
Tradenames: | 20 |
Applicants: | 19 |
NDAs: | 35 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 68 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 360 |
Patent Applications: | 6,953 |
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 |
---|---|
Emory University | Phase 3 |
Sanofi | Phase 3 |
John Harris | Phase 2/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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-003 | Jan 27, 2017 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Mylan | WIXELA INHUB | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208891-003 | Jan 30, 2019 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-008 | Apr 8, 2022 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 | 021433-003 | May 14, 2004 | See Plans and Pricing | See Plans and Pricing |
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | See Plans and Pricing | See Plans and Pricing |
Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-002 | Jan 27, 2017 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FLUTICASONE PROPIONATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
United Kingdom | 2453841 | Nasal delivery device | See Plans and Pricing |
China | 104428025 | Nasal delivery devices | See Plans and Pricing |
European Patent Office | 2197525 | DISPOSITIFS D'ADMINISTRATION NASALE (NASAL DELIVERY DEVICES) | See Plans and Pricing |
>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 | See Plans and Pricing | 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 | See Plans and Pricing | 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 |
1519731 | 13C0067 | France | See Plans and Pricing | 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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