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 |
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 |
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 RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-003 | Jan 27, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | 021254-002 | Jun 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 |
---|---|---|---|
Croatia | P20150103 | ⤷ Sign Up | |
Australia | 2015308748 | Compliance monitoring module for a breath-actuated inhaler | ⤷ Sign Up |
Eurasian Patent Organization | 201291267 | СЧЕТЧИКИ ДОЗ ДЛЯ ИНГАЛЯТОРОВ, ИНГАЛЯТОРЫ И ИХ РАБОЧИЕ ОСИ | ⤷ 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 |
---|---|---|---|---|
1305329 | SPC/GB08/026 | United Kingdom | ⤷ Sign Up | 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 |
2506844 | SPC/GB18/020 | United Kingdom | ⤷ Sign Up | 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 | 1890025-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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