ADVAIR DISKUS 250/50 Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
Which patents cover Advair Diskus 250/50, and when can generic versions of Advair Diskus 250/50 launch?
Advair Diskus 250/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.
The generic ingredient in ADVAIR DISKUS 250/50 is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Ten 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 250/50
A generic version of ADVAIR DISKUS 250/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
Summary for ADVAIR DISKUS 250/50
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Clinical Trials: | 59 |
Patent Applications: | 108 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ADVAIR DISKUS 250/50 at DailyMed |

Recent Clinical Trials for ADVAIR DISKUS 250/50
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 250/50
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ADVAIR DISKUS 250/50
US Patents and Regulatory Information for ADVAIR DISKUS 250/50
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 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | 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 250/50
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | 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 250/50
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 250/50
See the table below for patents covering ADVAIR DISKUS 250/50 around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Greece | 1002387 | ΣΥΣΚΕΥΗ ΕΙΣΠΝΟΩΝ. (INHALATION DEVICE) | ⤷ Try a Trial |
Hong Kong | 36889 | PHENETHANOLAMINE DERIVATIVES | ⤷ Try a Trial |
Switzerland | 651307 | ANDROSTA-CARBOTHIOSAEUREN UND VERFAHREN ZU IHRER HERSTELLUNG. | ⤷ Try a Trial |
Japan | 3110477 | ⤷ Try a Trial | |
Czech Republic | 9104028 | ⤷ Try a Trial | |
United Kingdom | 9404023 | ⤷ Try a Trial | |
Australia | 6729881 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADVAIR DISKUS 250/50
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1519731 | 132013902182575 | Italy | ⤷ Try a Trial | PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527 |
1305329 | 08C0014 | France | ⤷ Try a Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
0416951 | C990012 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SALMETEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN FLUTICASONPROPIONAAT,IN HET BIJZONDER SALMETEROLXINAFOAAT EN FLUTICASONPROPIONAAT; NATL REGISTRATION NO/DATE: RVG 23529 - RVG 23534 19990112; FIRST REGISTRATION: SE 14591 - 14596 19980907 |
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 |
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 |
1519731 | 13C0067 | France | ⤷ Try a Trial | 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 |