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Last Updated: October 1, 2022

AIRDUO RESPICLICK Drug Patent Profile


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

Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. There are sixteen patents protecting this drug.

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

The generic ingredient in AIRDUO RESPICLICK 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 RESPICLICK

AIRDUO RESPICLICK is protected by sixteen US patents and two FDA Regulatory Exclusivities.

Patents protecting AIRDUO RESPICLICK

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

Dry powder inhalation apparatus
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

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

FDA Regulatory Exclusivity protecting AIRDUO RESPICLICK

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 RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 RX Yes Yes 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 RESPICLICK

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 See Plans and Pricing See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 See Plans and Pricing See Plans and Pricing
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for AIRDUO RESPICLICK

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 RESPICLICK

When does loss-of-exclusivity occur for AIRDUO RESPICLICK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Patent: 8394
Estimated Expiration: See Plans and Pricing

Canada

Patent: 75957
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13221
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 99434
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 99434
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004031459
Estimated Expiration: See Plans and Pricing

Poland

Patent: 99434
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 99434
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 99434
Estimated Expiration: See Plans and Pricing

Spain

Patent: 62038
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AIRDUO RESPICLICK around the world.

Country Patent Number Title Estimated Expiration
Hungary E046522 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011144326 See Plans and Pricing
Australia 2014332191 Dry powder inhaler See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AIRDUO RESPICLICK

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
2506844 SPC/GB18/020 United Kingdom See Plans and Pricing PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Medtronic
Merck
Express Scripts
Mallinckrodt

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.