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Last Updated: June 29, 2022

AIRDUO DIGIHALER Drug Patent Profile


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Which patents cover Airduo Digihaler, and when can generic versions of Airduo Digihaler launch?

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

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

The generic ingredient in AIRDUO DIGIHALER is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

US Patents and Regulatory Information for AIRDUO DIGIHALER

AIRDUO DIGIHALER is protected by twenty-three US patents and two FDA Regulatory Exclusivities.

Patents protecting AIRDUO 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

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

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

Dry powder 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

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

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

FDA Regulatory Exclusivity protecting AIRDUO DIGIHALER

REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
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 AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-006 Jul 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-006 Jul 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-006 Jul 12, 2019 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 AIRDUO DIGIHALER

EU/EMA Drug Approvals for AIRDUO DIGIHALER

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva B.V. Airexar Spiromax salmeterol xinafoate, fluticasone propionate EMEA/H/C/004267
Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1
Withdrawn no no no 2016-08-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for AIRDUO DIGIHALER

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

Country Patent Number Title Estimated Expiration
Japan 2003535656 See Plans and Pricing
Australia 2001284643 See Plans and Pricing
Japan 2022058665 吸入器 See Plans and Pricing
European Patent Office 2514463 Compteurs de doses pour inhalateurs et méthode de dessiner un compteur de doses (Dose counters for inhalers and method of designing an incremental dose counter) See Plans and Pricing
European Patent Office 3097937 MODULE DE SURVEILLANCE DE LA CONFORMITÉ POUR UN INHALATEUR ACTIONNÉ PAR LA RESPIRATION (COMPLIANCE MONITORING MODULE FOR A BREATH-ACTUATED INHALER) See Plans and Pricing
South Korea 101618933 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AIRDUO 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 1890025-8 Sweden See Plans and Pricing PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1519731 92269 Luxembourg See Plans and Pricing PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
2506844 18C1022 France See Plans and Pricing PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/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:

Express Scripts
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Moodys
Medtronic
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McKesson

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