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Last Updated: July 6, 2020

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ADVAIR DISKUS 250/50 Drug 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. Seven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

Summary for ADVAIR DISKUS 250/50
Drug patent expirations by year for ADVAIR DISKUS 250/50
Recent Clinical Trials for ADVAIR DISKUS 250/50

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

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

See all ADVAIR DISKUS 250/50 clinical trials

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   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 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   Start Trial   Start Trial
Glaxo Grp Ltd ADVAIR DISKUS 250/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-002 Aug 24, 2000   Start Trial   Start Trial
Glaxo Grp Ltd ADVAIR DISKUS 250/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-002 Aug 24, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ADVAIR DISKUS 250/50

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 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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
Moodys
Boehringer Ingelheim
Baxter
McKesson

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