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Last Updated: June 27, 2022

ARMONAIR DIGIHALER Drug Patent 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 sixty 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. Sixty-six suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Armonair Digihaler

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

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US Patents and Regulatory Information for ARMONAIR DIGIHALER

ARMONAIR DIGIHALER is protected by twenty-one US patents and two FDA Regulatory Exclusivities.

Patents protecting ARMONAIR DIGIHALER

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Airflow adaptor for a breath-actuated dry powder inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compliance monitoring module for a breath-actuated inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dry powder inhalation apparatus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compliance monitoring module for a breath-actuated inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Drug delivery device with electronics and power management
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhalation device with integrated electronics
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Reservoir pressure system for medicament inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dry powder inhalation apparatus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Airflow adaptor for a breath-actuated dry powder inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Airflow adaptor for a breath-actuated dry powder inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dry powder inhalation apparatus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for preparing a medicament
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose counter for inhaler having a bore and shaft arrangement
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compliance monitoring module for a breath-actuated inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compliance monitoring module for a breath-actuated inhaler
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ARMONAIR DIGIHALER

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-004 Feb 20, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-004 Feb 20, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-005 Feb 20, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-005 Feb 20, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-005 Feb 20, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-005 Feb 20, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 ARMONAIR DIGIHALER

International Patents for ARMONAIR DIGIHALER

See the table below for patents covering ARMONAIR DIGIHALER around the world.

Country Patent Number Title Estimated Expiration
Brazil 112012029106 contadores de doses para inaladores, inaladores e eixos dos mesmos See Plans and Pricing
Australia 2015308748 Compliance monitoring module for a breath-actuated inhaler See Plans and Pricing
World Intellectual Property Organization (WIPO) 0200280 See Plans and Pricing
Israel 241912 מתאם זרימת אויר למשאף אבקה יבשה המופעל באמצעות נשימה (Airflow adaptor for a breath-actuated dry powder inhaler) See Plans and Pricing
Japan 5806354 See Plans and Pricing
Spain 2544277 See Plans and Pricing
Japan 2017525511 吸入器のためのコンプライアンス支援モジュール See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARMONAIR DIGIHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1305329 SPC/GB08/026 United Kingdom See Plans and Pricing PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
2506844 LUC00077 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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
1305329 08C0014 France See Plans and Pricing PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731 13C0067 France See Plans and Pricing 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
2506844 2018C/022 Belgium See Plans and Pricing 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
2506844 132018000000341 Italy See Plans and Pricing 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
>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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