airduo digihaler Drug Patent Profile
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Which patents cover Airduo Digihaler, and what generic alternatives are available?
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.
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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 |
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
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Dose counter for inhaler having an anti-reverse rotation actuator
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Airflow adaptor for a breath-actuated dry powder inhaler
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Dose counter for inhaler having an anti-reverse rotation actuator
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Compliance monitoring module for a breath-actuated inhaler
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Dry powder inhalation apparatus
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Compliance monitoring module for a breath-actuated inhaler
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Inhaler
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Drug delivery device with electronics and power management
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Inhalation device with integrated electronics
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Drug delivery device with electronics
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Drug delivery device with electronics
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Drug delivery device with electronics
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Drug delivery device with electronics
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Dry powder inhalation apparatus
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Airflow adaptor for a breath-actuated dry powder inhaler
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Dose counters for inhalers, inhalers and methods of assembly thereof
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Dry powder inhaler
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Dose counters for inhalers, inhalers and methods of assembly thereof
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Dry powder inhaler
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Dry powder inhalation apparatus
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Process for preparing a medicament
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Dose counter for inhaler having a bore and shaft arrangement
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Compliance monitoring module for a breath-actuated inhaler
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Compliance monitoring module for a breath-actuated inhaler
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Process for preparing a medicament
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FDA Regulatory Exclusivity protecting airduo digihaler
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
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PEDIATRIC EXCLUSIVITY
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Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | Jul 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 | 208799-006 | Jul 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | Jul 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | Jul 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
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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 |
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Croatia | P20150103 | ⤷ Sign Up | |
Argentina | 102057 | MÓDULO DE MONITOREO DE LA DOCILIDAD PARA UN INHALADOR ACCIONADO POR EL ALIENTO | ⤷ Sign Up |
Cyprus | 1113531 | ⤷ Sign Up | |
Eurasian Patent Organization | 201291267 | СЧЕТЧИКИ ДОЗ ДЛЯ ИНГАЛЯТОРОВ, ИНГАЛЯТОРЫ И ИХ РАБОЧИЕ ОСИ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for airduo digihaler
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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1305329 | SPC/GB08/026 | United Kingdom | ⤷ Sign Up | 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 | SPC/GB18/020 | United Kingdom | ⤷ Sign Up | 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 |
2506844 | 1890025-8 | Sweden | ⤷ Sign Up | 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 | LUC00077 | Luxembourg | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |