DrugPatentWatch Database Preview
ADVAIR DISKUS 100/50 Drug Profile
Email this page to a colleague
» See Plans and PricingWhen 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. Seven 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: | 48 |
| 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 |
Recent Litigation for ADVAIR DISKUS 100/50
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ART+COM Innovationpool GmbH v. Google Inc. | 2016-10-05 |
| Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-08 |
| Ted Miller Dairy, LLC | 2010-02-17 |
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 |
|---|---|---|
| Cyprus | 1291 | Start Trial |
| Germany | 19975040 | Start Trial |
| Switzerland | 644615 | Start Trial |
| Canada | 2024916 | Start Trial |
| Czech Republic | 9104034 | Start Trial |
| Germany | 4106379 | Start Trial |
| Japan | 3110477 | 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 | 08C0014 | France | Start Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
| 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 |
| 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 |
| 1519731 | 13C0067 | France | Start 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 |
| 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 |
| 2506844 | LUC00077 | Luxembourg | Start 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
