ADVAIR DISKUS 500/50 Drug Patent Profile
✉ Email this page to a colleague
When do Advair Diskus 500/50 patents expire, and what generic alternatives are available?
Advair Diskus 500/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.
The generic ingredient in ADVAIR DISKUS 500/50 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 500/50
A generic version of ADVAIR DISKUS 500/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ADVAIR DISKUS 500/50?
- What are the global sales for ADVAIR DISKUS 500/50?
- What is Average Wholesale Price for ADVAIR DISKUS 500/50?
Summary for ADVAIR DISKUS 500/50
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Clinical Trials: | 59 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ADVAIR DISKUS 500/50 at DailyMed |
Recent Clinical Trials for ADVAIR DISKUS 500/50
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Becro Ltd. | Phase 3 |
Teva Pharmaceuticals USA | Phase 3 |
Respirent Pharmaceuticals Co Ltd. | Phase 1 |
Pharmacology for ADVAIR DISKUS 500/50
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for ADVAIR DISKUS 500/50
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 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | AB | 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 ADVAIR DISKUS 500/50
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ADVAIR DISKUS 500/50
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 500/50
See the table below for patents covering ADVAIR DISKUS 500/50 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ireland | 810282 | ⤷ Sign Up | |
New Zealand | 237274 | POWDER INHALATOR: CONTAINERS OPENED BY PEELING SHEETS APART | ⤷ Sign Up |
United Kingdom | 9019659 | ⤷ Sign Up | |
Austria | 395428 | ⤷ Sign Up | |
Denmark | 175075 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADVAIR DISKUS 500/50
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0416951 | 12/1999 | Austria | ⤷ Sign Up | 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 |
2506844 | 132018000000341 | Italy | ⤷ Sign Up | PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117 |
2506844 | LUC00077 | Luxembourg | ⤷ Sign Up | 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 |
1519731 | 92269 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
1519731 | 13C0067 | France | ⤷ Sign Up | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |