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Last Updated: September 26, 2020

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ARMONAIR DIGIHALER Drug Profile

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When do Armonair Digihaler patents expire, and when can generic versions of Armonair Digihaler launch?

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

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

The generic ingredient in ARMONAIR DIGIHALER is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

US ANDA Litigation and Generic Entry Outlook for Armonair Digihaler

A generic version of ARMONAIR DIGIHALER was approved as fluticasone propionate by ANDA REPOSITORY on May 14th, 2004.

  Start Trial

Drug patent expirations by year for ARMONAIR DIGIHALER
Pharmacology for ARMONAIR DIGIHALER

US Patents and Regulatory Information for ARMONAIR 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 ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-005 Feb 20, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 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

Supplementary Protection Certificates for ARMONAIR DIGIHALER

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 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 08C0014 France   Start Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 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
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
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:

Johnson and Johnson
Colorcon
Harvard Business School
Mallinckrodt
Medtronic
Baxter

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