AIRDUO RESPICLICK Drug Patent Profile
✉ Email this page to a colleague
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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Airduo Respiclick
A generic version of AIRDUO RESPICLICK was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
Summary for AIRDUO RESPICLICK
International Patents: | 327 |
US Patents: | 15 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 8 |
Patent Applications: | 74 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AIRDUO RESPICLICK |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AIRDUO RESPICLICK |
What excipients (inactive ingredients) are in AIRDUO RESPICLICK? | AIRDUO RESPICLICK excipients list |
DailyMed Link: | AIRDUO RESPICLICK at DailyMed |
Pharmacology for AIRDUO RESPICLICK
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for AIRDUO RESPICLICK
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 | |||
Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-002 | Jan 27, 2017 | RX | Yes | No | ⤷ 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 | 208799-002 | Jan 27, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | Jan 27, 2017 | 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 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 | ⤷ 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 |
Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | 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 |
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 | 208799-003 | 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 |
---|---|---|---|
Uruguay | 26796 | SISTEMA DE MEDICIÓN DE DOSIS PARA INHALADOR DE MEDICAMENTOS | ⤷ Try a Trial |
Canada | 2799625 | COMPTEURS DE DOSES POUR INHALATEURS, INHALATEURS ET TIGES ASSOCIEES (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2005034833 | ⤷ Try a Trial | |
Japan | 2017525512 | 呼吸作動式の吸入器用のコンプライアンス監視モジュール | ⤷ Try a Trial |
Japan | 4511785 | ⤷ Try a Trial | |
United Kingdom | 0115523 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 9828033 | ⤷ 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 |
---|---|---|---|---|
1519731 | 92269 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
2506844 | LUC00077 | Luxembourg | ⤷ Try a Trial | 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 |
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 |
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 |
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 |
2506844 | 1890025-8 | Sweden | ⤷ Try a Trial | 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 | 13C0067 | France | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |