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-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fluticasone propionate; salmeterol xinafoate has four hundred and ninety-two patent family members in thirty-six countries.
Twelve suppliers are listed for this compound.
Summary for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
International Patents: | 492 |
US Patents: | 28 |
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 |
Imperial College London | Phase 4 |
European Research Council | 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 |
---|---|---|---|
Hong Kong | 1223311 | 用於吸入器的劑量計數器、吸入器及其軸 (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) | ⤷ Try a Trial |
European Patent Office | 3552646 | DISPOSITIF D'ADMINISTRATION DE MÉDICAMENT COMPRENANT UNE ÉLECTRONIQUE (DRUG DELIVERY DEVICE WITH ELECTRONICS) | ⤷ Try a Trial |
United Kingdom | 0311191 | ⤷ Try a Trial | |
South Korea | 101618933 | ⤷ Try a Trial | |
Canada | 3111537 | COMPTEURS DE DOSES POUR INHALATEURS, INHALATEURS ET TIGES ASSOCIEES (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) | ⤷ Try a Trial |
Israel | 247397 | מוני מינון למשאפים, משאפים, ועמודים למשאפים (Dose counters for inhalers and inhalers and shafts thereof) | ⤷ Try a Trial |
>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 | SPC/GB18/020 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117 |
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 |
1305329 | 08C0014 | France | ⤷ Try a Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
1519731 | 92269 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
2506844 | 132018000000341 | Italy | ⤷ Try a Trial | 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 |
1519731 | 13C0067 | France | ⤷ Try a Trial | 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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