WIXELA INHUB Drug Patent Profile
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Which patents cover Wixela Inhub, and when can generic versions of Wixela Inhub launch?
Wixela Inhub is a drug marketed by Mylan and is included in one NDA.
The generic ingredient in WIXELA INHUB 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 Wixela Inhub
A generic version of WIXELA INHUB was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
Summary for WIXELA INHUB
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for WIXELA INHUB |
| DailyMed Link: | WIXELA INHUB at DailyMed |
Pharmacology for WIXELA INHUB
| Drug Class | Corticosteroid beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for WIXELA INHUB
US Patents and Regulatory Information for WIXELA INHUB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | WIXELA INHUB | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208891-001 | Jan 30, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan | WIXELA INHUB | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208891-002 | Jan 30, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan | WIXELA INHUB | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208891-003 | Jan 30, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 WIXELA INHUB
| 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 |
