Airduo Digihaler is a drug owned by Teva Pharmaceutical Industries Ltd. It is protected by 59 US drug patents filed from 2019 to 2024. Out of these, 52 drug patents are active and 7 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6748947 | De-agglomerator for breath-actuated dry powder inhaler |
Jun, 2021
(3 years ago) |
Expired
|
| US6701917 | Dose counter for medicament inhaler |
Jun, 2021
(3 years ago) |
Expired
|
| US8006690 | Reservoir pressure system for medicament inhaler |
Jun, 2021
(3 years ago) |
Expired
|
| US6718972 | Dose metering system for medicament inhaler |
Jun, 2021
(3 years ago) |
Expired
|
| US6871646 | De-agglomerator for breath-actuated dry powder inhaler |
Jun, 2021
(3 years ago) |
Expired
|
| US7540282 | Reservoir pressure system for medicament inhaler |
May, 2023
(1 year, 2 months ago) |
Expired
|
|
US7540282 (Pediatric) | Reservoir pressure system for medicament inhaler |
Nov, 2023
(8 months ago) |
Expired
|
| US9616024 | Process for preparing a medicament |
Sep, 2024
(a month from now) | Active |
| US9987229 | Process for preparing a medicament |
Sep, 2024
(a month from now) | Active |
|
US9987229 (Pediatric) | Process for preparing a medicament |
Mar, 2025
(7 months from now) | Active |
|
US9616024 (Pediatric) | Process for preparing a medicament |
Mar, 2025
(7 months from now) | Active |
| US10765820 | Dry powder inhalation apparatus |
May, 2025
(9 months from now) | Active |
| US9463288 | Dry powder inhalation apparatus |
May, 2025
(9 months from now) | Active |
|
US10765820 (Pediatric) | Dry powder inhalation apparatus |
Nov, 2025
(1 year, 3 months from now) | Active |
|
US9463288 (Pediatric) | Dry powder inhalation apparatus |
Nov, 2025
(1 year, 3 months from now) | Active |
| US8651103 | Dry powder inhalation apparatus |
Mar, 2028
(3 years from now) | Active |
|
US8651103 (Pediatric) | Dry powder inhalation apparatus |
Sep, 2028
(4 years from now) | Active |
| US10195375 | Airflow adaptor for a breath-actuated dry powder inhaler |
Feb, 2031
(6 years from now) | Active |
| US10022510 | Dose counters for inhalers, inhalers and methods of assembly thereof |
May, 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 |
| US9216260 | Dose counters for inhalers, inhalers and methods of assembly thereof |
Jun, 2031
(6 years from now) | Active |
|
US10195375 (Pediatric) | Airflow adaptor for a breath-actuated dry powder inhaler |
Aug, 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 |
|
US10124131 (Pediatric) | Dose counter for inhaler having an anti-reverse rotation actuator |
Nov, 2031
(7 years from now) | Active |
|
US9216260 (Pediatric) | Dose counters for inhalers, inhalers and methods of assembly thereof |
Dec, 2031
(7 years from now) | Active |
| US10561808 | Dose counter for inhaler having an anti-reverse rotation actuator |
Jan, 2032
(7 years from now) | Active |
| US8978966 | Dose counters for inhalers, inhalers and methods of assembly thereof |
Jan, 2032
(7 years from now) | Active |
| US8714149 | Airflow adaptor for a breath-actuated dry powder inhaler |
Feb, 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 |
|
US8978966 (Pediatric) | Dose counters for inhalers, inhalers and methods of assembly thereof |
Jul, 2032
(7 years from now) | Active |
|
US8714149 (Pediatric) | Airflow adaptor for a breath-actuated dry powder inhaler |
Aug, 2032
(8 years from now) | Active |
| US9066957 | Dry powder inhaler |
Oct, 2034
(10 years from now) | Active |
| US9415008 | Dry powder inhaler |
Oct, 2034
(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 |
| US9782551 | Compliance monitoring module for a breath-actuated inhaler |
Aug, 2035
(11 years from now) | Active |
| US9782550 | Compliance monitoring module for a breath-actuated inhaler |
Aug, 2035
(11 years from now) | Active |
| US10918816 | Compliance monitoring module for a breath-actuated inhaler |
Dec, 2035
(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 (Pediatric) | Compliance monitoring module for a breath-actuated inhaler |
Jun, 2036
(11 years from now) | Active |
| US10569034 | Compliance monitoring module for a breath-actuated inhaler |
Aug, 2036
(12 years from now) | Active |
|
US10569034 (Pediatric) | Compliance monitoring module for a breath-actuated inhaler |
Feb, 2037
(12 years from now) | Active |
| US11351317 | Drug delivery device with electronics |
Feb, 2038
(13 years from now) | Active |
|
US11351317 (Pediatric) | Drug delivery device with electronics |
Aug, 2038
(14 years from now) | Active |
| US11357935 | Drug delivery device with electronics |
Sep, 2038
(14 years from now) | Active |
| US11000653 | Inhaler |
Dec, 2038
(14 years from now) | Active |
|
US11000653 (Pediatric) | Inhaler |
Jun, 2039
(14 years from now) | Active |
| US11969544 | Inhalers and airflow adaptors therefor |
Aug, 2039
(15 years from now) | Active |
| US11344685 | Drug delivery device with electronics |
Sep, 2039
(15 years from now) | Active |
|
US11344685 (Pediatric) | Drug delivery device with electronics |
Mar, 2040
(15 years from now) | Active |
| US11439777 | Drug delivery device with electronics |
May, 2040
(15 years from now) | Active |
| US11464923 | Inhaler system |
Jun, 2040
(15 years from now) | Active |
| US11173259 | Drug delivery device with electronics and power management |
Jul, 2040
(15 years from now) | Active |
|
US11173259 (Pediatric) | Drug delivery device with electronics and power management |
Jan, 2041
(16 years from now) | Active |
| US11266796 | Inhalation device with integrated electronics |
Feb, 2041
(16 years from now) | Active |
|
US11266796 (Pediatric) | Inhalation device with integrated electronics |
Aug, 2041
(17 years from now) | Active |
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.
Latest Legal Activities on Airduo Digihaler's Patents
Given below is the list of recent legal activities going on the following patents of Airduo Digihaler.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 has 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 or infringement 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10561808 | October, 2018 | Decision | 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 3 exclusivities out of which 2 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 |
|---|---|
| New Product(NP) | Jan 27, 2020 |
| M(M-61) | Jul 09, 2024 |
| Pediatric Exclusivity(PED) | Jan 09, 2025 |
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 |
|---|---|---|---|
| | |||
| 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
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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
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.
Market Authorisation 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 |
|---|---|---|---|
| 0.113MG/INH;EQ 0.014MG BASE/INH | POWDER | Discontinued | INHALATION |
| 0.232MG/INH;EQ 0.014MG BASE/INH | POWDER | Discontinued | INHALATION |
| 0.055MG/INH;EQ 0.014MG BASE/INH | POWDER | Discontinued | INHALATION |