AIRDUO DIGIHALER Drug Patent Profile
✉ Email this page to a colleague
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-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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Airduo Digihaler
A generic version of AIRDUO DIGIHALER was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
Summary for AIRDUO DIGIHALER
International Patents: | 463 |
US Patents: | 27 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for AIRDUO DIGIHALER |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AIRDUO DIGIHALER |
What excipients (inactive ingredients) are in AIRDUO DIGIHALER? | AIRDUO DIGIHALER excipients list |
DailyMed Link: | AIRDUO DIGIHALER at DailyMed |
Pharmacology for AIRDUO DIGIHALER
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for AIRDUO DIGIHALER
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 | |||
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 | 208799-006 | 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 | 208799-004 | Jul 12, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | Jul 12, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-004 | Jul 12, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-004 | Jul 12, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | 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 |
International Patents for AIRDUO DIGIHALER
See the table below for patents covering AIRDUO DIGIHALER around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 460955 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 0200281 | ⤷ Try a Trial | |
United Kingdom | 0115525 | ⤷ Try a Trial | |
Mexico | 365477 | ADAPTADOR DE FLUJO DE AIRE PARA UN INHALADOR DE POLVO SECO ACCIONADO POR LA RESPIRACION. (AIRFLOW ADAPTOR FOR A BREATH-ACTUATED DRY POWDER INHALER.) | ⤷ Try a Trial |
European Patent Office | 2189176 | Désagglomérateur pour inhalateur à poudre déclenché par l'inspiration (De-agglomerator for breath-actuated dry powder inhaler) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AIRDUO DIGIHALER
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 | 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 |
1305329 | 08C0014 | France | ⤷ Try a Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
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 |