ADVAIR DISKUS 250/50 Drug Patent Profile
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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. Nine 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: | 3 |
Clinical Trials: | 57 |
Patent Applications: | 103 |
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 |
---|---|
Teva Pharmaceuticals USA | Phase 3 |
Respirent Pharmaceuticals Co Ltd. | Phase 1 |
Becro 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | See Plans and Pricing | See Plans and Pricing |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | See Plans and Pricing | See Plans and Pricing |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | See Plans and Pricing | See Plans and Pricing |
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 |
---|---|---|---|
Denmark | 201784 | See Plans and Pricing | |
Philippines | 24267 | ANDROSTANE CARBOTHIOATES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME | See Plans and Pricing |
Czech Republic | 283168 | Inhalační přístroj (INHALATOR) | See Plans and Pricing |
Poland | 167736 | See Plans and Pricing | |
United Kingdom | 2137206 | ANDROSTANE 17-CARBOTHIOC ACID DERIVATIVES | See Plans and Pricing |
>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 |
---|---|---|---|---|
2506844 | 1890025-8 | Sweden | See Plans and Pricing | PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117 |
2506844 | LUC00077 | Luxembourg | See Plans and Pricing | 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 |
1305329 | 08C0014 | France | See Plans and Pricing | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
1305329 | SPC/GB08/026 | United Kingdom | See Plans and Pricing | 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 |
0416951 | C990012 | Netherlands | See Plans and Pricing | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |