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Last Updated: January 28, 2020

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ADVAIR HFA Drug Profile

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When do Advair Hfa patents expire, and what generic alternatives are available?

Advair Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and twenty patent family members in thirty-five countries.

The generic ingredient in ADVAIR HFA 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.

US ANDA Litigation and Generic Entry Outlook for Advair Hfa

Advair Hfa was eligible for patent challenges on December 31, 1968.

Annual sales in 2017 were $1.3bn, indicating a strong incentive for generic entry (peak sales were $1.6bn in 2016).

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ADVAIR HFA
Drug Prices for ADVAIR HFA

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Drug Sales Revenue Trends for ADVAIR HFA

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Recent Clinical Trials for ADVAIR HFA

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 HFA clinical trials

Recent Litigation for ADVAIR HFA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Glaxo Group Ltd. v. Teva Pharmaceuticals USA, Inc.2017-03-31
ART+COM Innovationpool GmbH v. Google Inc.2016-10-05
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-08

See all ADVAIR HFA litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2015-09-29

See all ADVAIR HFA litigation

US Patents and Regulatory Information for ADVAIR HFA

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 HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-002 Jun 8, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006 RX Yes Yes   Start Trial   Start Trial Y   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 HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006   Start Trial   Start Trial
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006   Start Trial   Start Trial
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ADVAIR HFA

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson
Medtronic
Mallinckrodt
Merck

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