ADVAIR DISKUS 100/50 Drug Patent Profile
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When do Advair Diskus 100/50 patents expire, and when can generic versions of Advair Diskus 100/50 launch?
Advair Diskus 100/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.
The generic ingredient in ADVAIR DISKUS 100/50 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 Advair Diskus 100/50
A generic version of ADVAIR DISKUS 100/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
Summary for ADVAIR DISKUS 100/50

Recent Clinical Trials for ADVAIR DISKUS 100/50
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Becro Ltd. | Phase 3 |
Teva Pharmaceuticals USA | Phase 3 |
Becro Ltd. | Phase 1 |
Pharmacology for ADVAIR DISKUS 100/50
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ADVAIR DISKUS 100/50
US Patents and Regulatory Information for ADVAIR DISKUS 100/50
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for ADVAIR DISKUS 100/50
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ADVAIR DISKUS 100/50
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 ADVAIR DISKUS 100/50
See the table below for patents covering ADVAIR DISKUS 100/50 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Bulgaria | 61490 | ⤷ Try a Trial | |
United Kingdom | 2088877 | ANDROSTANE 17 CARBOTHIOATES | ⤷ Try a Trial |
Spain | 8502447 | ⤷ Try a Trial | |
Japan | H0569817 | ⤷ Try a Trial | |
United Kingdom | 8329568 | ⤷ Try a Trial | |
Switzerland | 644615 | ANDROSTAN-CARBOTHIOATE, VERFAHREN ZU DEREN HERSTELLUNG UND DIESE ENTHALTENDE PHARMAZEUTISCHE ZUSAMMENSETZUNGEN. | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADVAIR DISKUS 100/50
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 |
1519731 | 92269 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
1305329 | SPC/GB08/026 | United Kingdom | ⤷ Try a Trial | 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 | 2018C/022 | Belgium | ⤷ Try a Trial | PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 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 |
0416951 | 12/1999 | Austria | ⤷ Try a Trial | PRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |