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Last Updated: May 29, 2020

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ADVAIR DISKUS 500/50 Drug Profile


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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. Seven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

Summary for ADVAIR DISKUS 500/50
Drug patent expirations by year for ADVAIR DISKUS 500/50
Recent Clinical Trials for ADVAIR DISKUS 500/50

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Respirent Pharmaceuticals Co Ltd.Phase 1
BECRO Ltd.Phase 1
Teva Pharmaceuticals USAPhase 3

See all ADVAIR DISKUS 500/50 clinical trials

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   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 500/50

Supplementary Protection Certificates for ADVAIR DISKUS 500/50

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 2018C/022 Belgium   Start 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
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 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
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 92269 Luxembourg   Start Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
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

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
McKinsey
Moodys
Boehringer Ingelheim
AstraZeneca

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