Fluticasone propionate - Generic Drug Details
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What are the generic drug 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 thirty-seven 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 forty-five patent family members in forty countries.
There are twenty-four drug master file entries for fluticasone propionate. Sixty-six suppliers are listed for this compound.
Summary for fluticasone propionate
International Patents: | 745 |
US Patents: | 37 |
Tradenames: | 20 |
Applicants: | 19 |
NDAs: | 35 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 66 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 353 |
Patent Applications: | 7,113 |
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 |
---|---|
Glenmark Pharmaceuticals Ltd. India | Phase 3 |
University of South Florida | Phase 4 |
Andover Research Eye Institute | Phase 4 |
Pharmacology for fluticasone propionate
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for fluticasone propionate
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 | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-002 | Jan 27, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | Jul 12, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-004 | Feb 20, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | Jan 27, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-002 | Jan 27, 2017 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-004 | Jul 12, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Padagis Israel | FLUTICASONE PROPIONATE | fluticasone propionate | LOTION;TOPICAL | 091553-001 | Jul 30, 2013 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | 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 | 021433-002 | May 14, 2004 | See Plans and Pricing | See Plans and Pricing |
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | 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 |
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | See Plans and Pricing | See Plans and Pricing |
Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-003 | Jan 27, 2017 | See Plans and Pricing | See Plans and Pricing |
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 |
>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 | 2405800 | Nasal devices | See Plans and Pricing |
China | 105903113 | 用于吸入器的剂量计数器、吸入器及其轴 (Dose counters for inhalers, inhalers and shafts thereof) | See Plans and Pricing |
United Kingdom | 2365778 | Dose metering system for medicament inhaler | See Plans and Pricing |
Spain | 2620803 | See Plans and Pricing | |
Japan | 2014221416 | 呼吸作動式ドライパウダー吸入器のための空気流アダプタ (AIRFLOW ADAPTOR FOR BREATH-ACTUATED DRY POWDER INHALER) | See Plans and Pricing |
Australia | 8464301 | See Plans and Pricing | |
Denmark | 1180378 | 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 |
---|---|---|---|---|
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 |
2506844 | LUC00077 | Luxembourg | See Plans and Pricing | 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 |
2506844 | 18C1022 | France | See Plans and Pricing | 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 |
1305329 | 08C0014 | France | See Plans and Pricing | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
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 |
1519731 | 92269 | Luxembourg | See Plans and Pricing | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
1519731 | 132013902182575 | Italy | See Plans and Pricing | 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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