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-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fluticasone propionate; salmeterol xinafoate has five hundred and twenty patent family members in thirty-seven countries.
Nine suppliers are listed for this compound.
Summary for fluticasone propionate; salmeterol xinafoate
International Patents: | 520 |
US Patents: | 24 |
Tradenames: | 8 |
Applicants: | 5 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 9 |
Clinical Trials: | 41 |
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 |
---|---|
European Research Council | Phase 4 |
Imperial College London | Phase 4 |
Respirent Pharmaceuticals Co Ltd. | Phase 1 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for fluticasone propionate; salmeterol xinafoate
US Patents and Regulatory Information for fluticasone propionate; salmeterol xinafoate
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 DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | 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 RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-003 | Jan 27, 2017 | RX | Yes | Yes | 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; salmeterol xinafoate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-001 | Jun 8, 2006 | See Plans and Pricing | See Plans and Pricing |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | See Plans and Pricing | See Plans and Pricing |
Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-002 | 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; salmeterol xinafoate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 201291267 | СЧЕТЧИКИ ДОЗ ДЛЯ ИНГАЛЯТОРОВ, ИНГАЛЯТОРЫ И ИХ РАБОЧИЕ ОСИ | See Plans and Pricing |
South Africa | 201601960 | DRY POWDER INHALER | See Plans and Pricing |
Australia | 2015308424 | Compliance-assisting module for an inhaler | See Plans and Pricing |
>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 |
---|---|---|---|---|
1519731 | 92269 | Luxembourg | See Plans and Pricing | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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