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Last Updated: March 28, 2024

~ Buy the AIRDUO DIGIHALER (fluticasone propionate; salmeterol xinafoate) Drug Profile, 2024 PDF Report in the Report Store ~

AIRDUO DIGIHALER Drug Patent Profile


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When do Airduo Digihaler patents expire, 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-seven patents protecting this drug.

This drug has four hundred and sixty-three 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. Twelve 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-seven US patents and two FDA Regulatory Exclusivities.

Patents protecting AIRDUO DIGIHALER

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Airflow adaptor for a breath-actuated dry powder inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counter for inhaler having an anti-reverse rotation actuator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compliance monitoring module for a breath-actuated inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dry powder inhalation apparatus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compliance monitoring module for a breath-actuated inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Drug delivery device with electronics and power management
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhalation device with integrated electronics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Drug delivery device with electronics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Drug delivery device with electronics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Drug delivery device with electronics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Drug delivery device with electronics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dry powder inhalation apparatus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Airflow adaptor for a breath-actuated dry powder inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dry powder inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counters for inhalers, inhalers and methods of assembly thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dry powder inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dry powder inhalation apparatus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Process for preparing a medicament
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose counter for inhaler having a bore and shaft arrangement
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compliance monitoring module for a breath-actuated inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compliance monitoring module for a breath-actuated inhaler
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Process for preparing a medicament
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting AIRDUO DIGIHALER

REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 208799-006 Jul 12, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 AIRDUO DIGIHALER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 ⤷  Try a Trial ⤷  Try a Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 ⤷  Try a Trial ⤷  Try a Trial
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Supplementary Protection Certificates for AIRDUO DIGIHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 2018C/022 Belgium ⤷  Try a 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
1519731 92269 Luxembourg ⤷  Try a Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329 SPC/GB08/026 United Kingdom ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.