FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - Generic Drug Details
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What are the generic drug sources for fluticasone propionate; salmeterol xinafoate and what is the scope of patent protection?
Fluticasone propionate; salmeterol xinafoate
is the generic ingredient in eight branded drugs marketed by Glaxo Grp Ltd, Teva Pharm, Hikma, Teva Pharms Usa, and Mylan, and is included in six NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fluticasone propionate; salmeterol xinafoate has four hundred and sixty-three patent family members in thirty-six countries.
Twelve suppliers are listed for this compound.
Summary for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
International Patents: | 463 |
US Patents: | 27 |
Tradenames: | 8 |
Applicants: | 5 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 12 |
Clinical Trials: | 43 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
DailyMed Link: | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE at DailyMed |
Recent Clinical Trials for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Novartis Pharmaceuticals | Phase 3 |
European Research Council | Phase 4 |
Imperial College London | Phase 4 |
See all FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE clinical trials
Pharmacology for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Expired US Patents for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
EU/EMA Drug Approvals for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Teva B.V. | Airexar Spiromax | salmeterol xinafoate, fluticasone propionate | EMEA/H/C/004267 Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 |
Withdrawn | no | no | no | 2016-08-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101618934 | ⤷ Sign Up | |
South Korea | 101618932 | ⤷ Sign Up | |
Australia | 2020200005 | Compliance-assisting module for an inhaler | ⤷ Sign Up |
Japan | 2013526353 | ⤷ Sign Up | |
European Patent Office | 2596827 | Adaptateur d'écoulement d'air pour un inhalateur à poudre sèche actionné par la respiration (Airflow adaptor for a breath-actuated dry powder inhaler) | ⤷ Sign Up |
Hong Kong | 1219444 | 干粉吸入器 (DRY POWDER INHALER) | ⤷ Sign Up |
Eurasian Patent Organization | 201690641 | ИНКРЕМЕНТАЛЬНЫЙ СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА ОТМЕРЕННЫХ ДОЗ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | LUC00077 | Luxembourg | ⤷ Sign Up | 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 | ⤷ 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 |
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 | 08C0014 | France | ⤷ Sign Up | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
1519731 | 92269 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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