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ADVAIR DISKUS 100/50 Drug 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. Eight suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for ADVAIR DISKUS 100/50
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Clinical Trials: | 52 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADVAIR DISKUS 100/50 |
| DailyMed Link: | ADVAIR DISKUS 100/50 at DailyMed |
Recent Clinical Trials for ADVAIR DISKUS 100/50
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| BECRO Ltd. | Phase 1 |
| Respirent Pharmaceuticals Co Ltd. | Phase 1 |
| Teva Pharmaceuticals USA | Phase 3 |
Pharmacology for ADVAIR DISKUS 100/50
| Drug Class | beta2-Adrenergic Agonist Corticosteroid |
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
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 | Start Trial | Start Trial | Start 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
International Patents for ADVAIR DISKUS 100/50
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 9004781 | Start Trial |
| France | 2477156 | Start Trial |
| Germany | 69005951 | Start Trial |
| Switzerland | 661497 | Start Trial |
| Argentina | 247721 | Start Trial |
| Brazil | 9100843 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ADVAIR DISKUS 100/50
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1305329 | SPC/GB08/026 | United Kingdom | Start Trial | PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111 |
| 2506844 | 18C1022 | France | Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117 |
| 2506844 | 132018000000341 | Italy | Start Trial | 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 |
| 1519731 | 132013902182575 | Italy | Start 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 |
| 0416951 | C990012 | Netherlands | Start 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 | 1890025-8 | Sweden | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
