Airduo Digihaler Patent Expiration

Airduo Digihaler is a drug owned by Teva Pharmaceutical Industries Ltd. It is protected by 60 US drug patents filed from 2019 to 2024. Out of these, 51 drug patents are active and 9 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 22, 2041. Details of Airduo Digihaler's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11266796

(Pediatric)

Inhalation device with integrated electronics
Aug, 2041

(16 years from now)

Active
US11266796 Inhalation device with integrated electronics
Feb, 2041

(16 years from now)

Active
US11173259

(Pediatric)

Drug delivery device with electronics and power management
Jan, 2041

(16 years from now)

Active
US11173259 Drug delivery device with electronics and power management
Jul, 2040

(15 years from now)

Active
US11464923 Inhaler system
Jun, 2040

(15 years from now)

Active
US11439777 Drug delivery device with electronics
May, 2040

(15 years from now)

Active
US11344685

(Pediatric)

Drug delivery device with electronics
Mar, 2040

(15 years from now)

Active
US11969544

(Pediatric)

Inhalers and airflow adaptors therefor
Feb, 2040

(15 years from now)

Active
US11344685 Drug delivery device with electronics
Sep, 2039

(14 years from now)

Active
US11969544 Inhalers and airflow adaptors therefor
Aug, 2039

(14 years from now)

Active
US11000653

(Pediatric)

Inhaler
Jun, 2039

(14 years from now)

Active
US11000653 Inhaler
Dec, 2038

(14 years from now)

Active
US11357935 Drug delivery device with electronics
Sep, 2038

(13 years from now)

Active
US11351317

(Pediatric)

Drug delivery device with electronics
Aug, 2038

(13 years from now)

Active
US11351317 Drug delivery device with electronics
Feb, 2038

(13 years from now)

Active
US10569034

(Pediatric)

Compliance monitoring module for a breath-actuated inhaler
Feb, 2037

(12 years from now)

Active
US10569034 Compliance monitoring module for a breath-actuated inhaler
Aug, 2036

(11 years from now)

Active
US10918816

(Pediatric)

Compliance monitoring module for a breath-actuated inhaler
Jun, 2036

(11 years from now)

Active
US9782551

(Pediatric)

Compliance monitoring module for a breath-actuated inhaler
Feb, 2036

(11 years from now)

Active
US9782550

(Pediatric)

Compliance monitoring module for a breath-actuated inhaler
Feb, 2036

(11 years from now)

Active
US10918816 Compliance monitoring module for a breath-actuated inhaler
Dec, 2035

(11 years from now)

Active
US9782551 Compliance monitoring module for a breath-actuated inhaler
Aug, 2035

(10 years from now)

Active
US9782550 Compliance monitoring module for a breath-actuated inhaler
Aug, 2035

(10 years from now)

Active
US9066957

(Pediatric)

Dry powder inhaler
Apr, 2035

(10 years from now)

Active
US9415008

(Pediatric)

Dry powder inhaler
Apr, 2035

(10 years from now)

Active
US9066957 Dry powder inhaler
Oct, 2034

(9 years from now)

Active
US9415008 Dry powder inhaler
Oct, 2034

(9 years from now)

Active
US8714149

(Pediatric)

Airflow adaptor for a breath-actuated dry powder inhaler
Aug, 2032

(7 years from now)

Active
US8978966

(Pediatric)

Dose counters for inhalers, inhalers and methods of assembly thereof
Jul, 2032

(7 years from now)

Active
US10561808

(Pediatric)

Dose counter for inhaler having an anti-reverse rotation actuator
Jul, 2032

(7 years from now)

Active
US8714149 Airflow adaptor for a breath-actuated dry powder inhaler
Feb, 2032

(7 years from now)

Active
US8978966 Dose counters for inhalers, inhalers and methods of assembly thereof
Jan, 2032

(7 years from now)

Active
US10561808 Dose counter for inhaler having an anti-reverse rotation actuator
Jan, 2032

(7 years from now)

Active
US9216260

(Pediatric)

Dose counters for inhalers, inhalers and methods of assembly thereof
Dec, 2031

(7 years from now)

Active
US10124131

(Pediatric)

Dose counter for inhaler having an anti-reverse rotation actuator
Nov, 2031

(7 years from now)

Active
US9731087

(Pediatric)

Dose counter for inhaler having a bore and shaft arrangement
Nov, 2031

(7 years from now)

Active
US10022510

(Pediatric)

Dose counters for inhalers, inhalers and methods of assembly thereof
Nov, 2031

(7 years from now)

Active
US10195375

(Pediatric)

Airflow adaptor for a breath-actuated dry powder inhaler
Aug, 2031

(6 years from now)

Active
US9216260 Dose counters for inhalers, inhalers and methods of assembly thereof
Jun, 2031

(6 years from now)

Active
US9731087 Dose counter for inhaler having a bore and shaft arrangement
May, 2031

(6 years from now)

Active
US10124131 Dose counter for inhaler having an anti-reverse rotation actuator
May, 2031

(6 years from now)

Active
US10022510 Dose counters for inhalers, inhalers and methods of assembly thereof
May, 2031

(6 years from now)

Active
US10195375 Airflow adaptor for a breath-actuated dry powder inhaler
Feb, 2031

(6 years from now)

Active
US8651103

(Pediatric)

Dry powder inhalation apparatus
Sep, 2028

(3 years from now)

Active
US8651103 Dry powder inhalation apparatus
Mar, 2028

(3 years from now)

Active
US10765820

(Pediatric)

Dry powder inhalation apparatus
Nov, 2025

(1 year, 1 month from now)

Active
US9463288

(Pediatric)

Dry powder inhalation apparatus
Nov, 2025

(1 year, 1 month from now)

Active
US10765820 Dry powder inhalation apparatus
May, 2025

(7 months from now)

Active
US9463288 Dry powder inhalation apparatus
May, 2025

(7 months from now)

Active
US9987229

(Pediatric)

Process for preparing a medicament
Mar, 2025

(4 months from now)

Active
US9616024

(Pediatric)

Process for preparing a medicament
Mar, 2025

(4 months from now)

Active
US9616024 Process for preparing a medicament
Sep, 2024

(a month ago)

Expired
US9987229 Process for preparing a medicament
Sep, 2024

(a month ago)

Expired
US7540282

(Pediatric)

Reservoir pressure system for medicament inhaler
Nov, 2023

(11 months ago)

Expired
US7540282 Reservoir pressure system for medicament inhaler
May, 2023

(1 year, 5 months ago)

Expired
US8006690 Reservoir pressure system for medicament inhaler
Jun, 2021

(3 years ago)

Expired
US6748947 De-agglomerator for breath-actuated dry powder inhaler
Jun, 2021

(3 years ago)

Expired
US6871646 De-agglomerator for breath-actuated dry powder inhaler
Jun, 2021

(3 years ago)

Expired
US6718972 Dose metering system for medicament inhaler
Jun, 2021

(3 years ago)

Expired
US6701917 Dose counter for medicament inhaler
Jun, 2021

(3 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Airduo Digihaler's patents.

Given below is the list of recent legal activities going on the following patents of Airduo Digihaler.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 21 Mar, 2024 US9463288
Payment of Maintenance Fee, 4th Year, Large Entity 21 Feb, 2024 US10765820
Payment of Maintenance Fee, 8th Year, Large Entity 24 Jan, 2024 US9415008
Expire Patent 02 Oct, 2023 US8006690
Payment of Maintenance Fee, 4th Year, Large Entity 20 Jul, 2023 US10561808
Payment of Maintenance Fee, 4th Year, Large Entity 20 Jul, 2023 US10569034
Payment of Maintenance Fee, 8th Year, Large Entity 23 May, 2023 US9216260
Maintenance Fee Reminder Mailed 19 Apr, 2023 US8006690
Payment of Maintenance Fee, 8th Year, Large Entity 21 Dec, 2022 US9066957
Recordation of Patent Grant Mailed 11 Oct, 2022 US11464923


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Airduo Digihaler and ongoing litigations to help you estimate the early arrival of Airduo Digihaler generic.

Airduo Digihaler's Litigations

Airduo Digihaler been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 26, 2018, against patent number US10561808. The petitioner , challenged the validity of this patent, with Declan Walsh et al. as the respondent. Click below to track the latest information on how companies are challenging Airduo Digihaler's patents.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10561808 October, 2018 Decision
(20 Sep, 2019)
Declan Walsh et al.


FDA has granted some exclusivities to Airduo Digihaler. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Airduo Digihaler, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Airduo Digihaler.

Exclusivity Information

Airduo Digihaler holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Airduo Digihaler's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-61) Jul 09, 2024
Pediatric Exclusivity(PED) Jan 09, 2025

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Several oppositions have been filed on Airduo Digihaler's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Airduo Digihaler's generic, the next section provides detailed information on ongoing and past EP oppositions related to Airduo Digihaler patents.

Airduo Digihaler's Oppositions Filed in EPO

Airduo Digihaler has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 03, 2009, by Vectura Delivery Devices Limited. This opposition was filed on patent number EP01948660A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP20172454A Nov, 2022 Vectura Limited Granted and Under Opposition
EP19155324A Jun, 2021 Vectura Limited Granted and Under Opposition
EP17811276A Mar, 2021 VECTURA DELIVERY DEVICES LIMITED Opposition rejected
EP17800844A Jun, 2020 Vectura Limited Opposition rejected
EP17800844A Feb, 2020 CHIESI FARMACEUTICI S.p.A. Opposition rejected
EP04782768A Apr, 2015 AstraZeneca Pharma Poland Sp. z.o.o. Revoked
EP01948660A Aug, 2014 Hexal Aktiengesellschaft Patent maintained as amended
EP04782768A Nov, 2011 Vectura Limited Revoked
EP04782768A Nov, 2011 AstraZeneca AB Revoked
EP01948660A Sep, 2009 Vectura Delivery Devices Limited Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Airduo Digihaler is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Airduo Digihaler's family patents as well as insights into ongoing legal events on those patents.

Airduo Digihaler's Family Patents

Airduo Digihaler has patent protection in a total of 38 countries. It's US patent count contributes only to 17.6% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Airduo Digihaler.

Family Patents

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Generic Launch

Generic Release Date:

Airduo Digihaler's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 22, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Airduo Digihaler Generics:

Fluticasone Propionate; Salmeterol Xinafoate is the generic name for the brand Airduo Digihaler. 3 different companies have already filed for the generic of Airduo Digihaler, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Airduo Digihaler's generic

Alternative Brands for Airduo Digihaler

Airduo Digihaler which is used for treating asthma., has several other brand drugs in the same treatment category and using the same active ingredient (Fluticasone Propionate; Salmeterol Xinafoate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Organon Llc
Asmanex Hfa Used for the treatment of asthma.
Asmanex Twisthaler Used for managing and controlling symptoms of asthma.
Teva Pharm
Airduo Respiclick

(uses Fluticasone Propionate; Salmeterol Xinafoate)

Used for managing and treating asthma.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Fluticasone Propionate; Salmeterol Xinafoate. Given below is the list of those drugs and companies owning them.



Apart from brand drugs containing the same ingredient, some generics have also been filed for Fluticasone Propionate; Salmeterol Xinafoate, Airduo Digihaler's active ingredient. Check the complete list of approved generic manufacturers for Airduo Digihaler





About Airduo Digihaler

Airduo Digihaler is a drug owned by Teva Pharmaceutical Industries Ltd. It is used for treating asthma. Airduo Digihaler uses Fluticasone Propionate; Salmeterol Xinafoate as an active ingredient. Airduo Digihaler was launched by Teva Pharm in 2019.

Approval Date:

Airduo Digihaler was approved by FDA for market use on 12 July, 2019.

Active Ingredient:

Airduo Digihaler uses Fluticasone Propionate; Salmeterol Xinafoate as the active ingredient. Check out other Drugs and Companies using Fluticasone Propionate; Salmeterol Xinafoate ingredient

Treatment:

Airduo Digihaler is used for treating asthma.

Dosage:

Airduo Digihaler is available in powder form for inhalation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.055MG/INH;EQ 0.014MG BASE/INH POWDER Discontinued INHALATION
0.113MG/INH;EQ 0.014MG BASE/INH POWDER Discontinued INHALATION
0.232MG/INH;EQ 0.014MG BASE/INH POWDER Discontinued INHALATION


Airduo Digihaler News

Teva under investigation by FTC for disputed product patents in the pharmaceutical industry

02 Jul, 2024

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