FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE Drug Patent Profile
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Which patents cover Fluticasone Propionate And Salmeterol Xinafoate, and when can generic versions of Fluticasone Propionate And Salmeterol Xinafoate launch?
Fluticasone Propionate And Salmeterol Xinafoate is a drug marketed by Hikma and Teva Pharms Usa and is included in two NDAs.
The generic ingredient in FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fluticasone Propionate And Salmeterol Xinafoate
A generic version of FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
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Questions you can ask:
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Summary for FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 8 |
| Clinical Trials: | 43 |
| Patent Applications: | 63 |
| DailyMed Link: | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE at DailyMed |
Recent Clinical Trials for FLUTICASONE PROPIONATE AND 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 AND SALMETEROL XINAFOATE clinical trials
Pharmacology for FLUTICASONE PROPIONATE AND 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 AND SALMETEROL XINAFOATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 203433-001 | Dec 17, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 213948-001 | Dec 13, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 203433-002 | Dec 17, 2020 | AB | RX | No | No | ⤷ 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 |
EU/EMA Drug Approvals for FLUTICASONE PROPIONATE AND 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 |
