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Last Updated: March 19, 2024

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

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 fifteen patents protecting this drug.

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

The generic ingredient in AIRDUO RESPICLICK 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 RESPICLICK

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

Patents protecting AIRDUO RESPICLICK

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

Dry powder inhalation apparatus
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

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

FDA Regulatory Exclusivity protecting AIRDUO RESPICLICK

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 RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 RX Yes Yes ⤷  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 RESPICLICK

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-003 Jan 27, 2017 ⤷  Try a Trial ⤷  Try a Trial
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 ⤷  Try a Trial ⤷  Try a Trial
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-001 Jan 27, 2017 ⤷  Try a Trial ⤷  Try a Trial
>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

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

Country Patent Number Title Estimated Expiration
China 105636630 Dry powder inhaler ⤷  Try a Trial
European Patent Office 3552645 DISPOSITIF D'ADMINISTRATION DE MÉDICAMENT COMPRENANT UNE ÉLECTRONIQUE (DRUG DELIVERY DEVICE WITH ELECTRONICS) ⤷  Try a Trial
Cyprus 1113531 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AIRDUO RESPICLICK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 18C1022 France ⤷  Try a Trial 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 ⤷  Try a 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 ⤷  Try a 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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