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Last Updated: January 25, 2020

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AIRDUO DIGIHALER Drug Profile

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Which patents cover Airduo Digihaler, and what generic alternatives are available?

Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has four hundred and thirty-five patent family members in thirty-six countries.

The generic ingredient in AIRDUO DIGIHALER 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 Airduo Digihaler

Airduo Digihaler was eligible for patent challenges on December 31, 1968.

Indicators of Generic Entry

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Summary for AIRDUO DIGIHALER
International Patents:435
US Patents:21
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Formulation / Manufacturing:see details
DailyMed Link:AIRDUO DIGIHALER at DailyMed
Drug patent expirations by year for AIRDUO DIGIHALER

US Patents and Regulatory Information for AIRDUO DIGIHALER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-006 Jul 12, 2019 RX Yes No   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

Supplementary Protection Certificates for AIRDUO DIGIHALER

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
1305329 08C0014 France   Start Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Medtronic
Express Scripts
Dow
Boehringer Ingelheim

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