AIRDUO DIGIHALER Drug Patent Profile
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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-eight patents protecting this drug.
This drug has four hundred and eighty-seven patent family members in thirty-seven 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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Questions you can ask:
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Summary for AIRDUO DIGIHALER
International Patents: | 487 |
US Patents: | 28 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
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-eight 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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Patent Expiration: ⤷ Sign Up
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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-005 | Jul 12, 2019 | DISCN | 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 | 208799-005 | 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 |
Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | 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 |
---|---|---|---|
Japan | 2021183164 | 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 (COMPLIANCE MONITORING MODULE FOR BREATH-ACTUATED INHALER) | ⤷ Sign Up |
Israel | 223117 | מוני מינון למשאפים ומשאפים ועמודים למשאפים (Dose counters for inhalers and inhalers and shafts thereof) | ⤷ Sign Up |
Spain | 2222525 | ⤷ 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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2506844 | 18C1022 | France | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 2018C/022 | Belgium | ⤷ Sign Up | PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |