Proair Digihaler is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 27 US drug patents filed from 2019 to 2022. Out of these, 21 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 22, 2041. Details of Proair 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 | Inhalation device with integrated electronics |
Feb, 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 | Drug delivery device with electronics |
Sep, 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 | Drug delivery device with electronics |
Feb, 2038
(13 years from now) | Active |
| US10569034 | Compliance monitoring module for a breath-actuated inhaler |
Aug, 2036
(11 years from now) | Active |
| US10918816 | Compliance monitoring module for a breath-actuated inhaler |
Dec, 2035
(10 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 |
| 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 | 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 |
| US8651103 | Dry powder inhalation apparatus |
Mar, 2028
(3 years from now) | Active |
| US10765820 | Dry powder inhalation apparatus |
May, 2025
(4 months from now) | Active |
| US9463288 | Dry powder inhalation apparatus |
May, 2025
(4 months from now) | Active |
| US7540282 | Reservoir pressure system for medicament inhaler |
May, 2023
(1 year, 7 months ago) |
Expired
|
| US6871646 | 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
|
| US6748947 | 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
|
| US8006690 | Reservoir pressure system 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 Proair Digihaler's patents.
Latest Legal Activities on Proair Digihaler's Patents
Given below is the list of recent legal activities going on the following patents of Proair Digihaler.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Mar, 2024 | US9463288 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Feb, 2024 | US10765820 |
| Expire Patent Critical | 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 Critical | 19 Apr, 2023 | US8006690 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Oct, 2022 | US11464923 |
| Recordation of Patent Grant Mailed Critical | 11 Oct, 2022 | US11464923 |
| Email Notification Critical | 22 Sep, 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 Proair Digihaler and ongoing litigations to help you estimate the early arrival of Proair Digihaler generic.
Proair Digihaler's Litigations
Proair 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 Proair Digihaler's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10561808 | October, 2018 |
Decision
(20 Sep, 2019) | Declan Walsh et al. | |
Several oppositions have been filed on Proair 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 Proair Digihaler's generic, the next section provides detailed information on ongoing and past EP oppositions related to Proair Digihaler patents.
Proair Digihaler's Oppositions Filed in EPO
Proair 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 |
| EP01948660A | Aug, 2014 | Hexal Aktiengesellschaft | Patent maintained as amended |
| EP01948660A | Sep, 2009 | Vectura Delivery Devices Limited | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Proair 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 Proair Digihaler's family patents as well as insights into ongoing legal events on those patents.
Proair Digihaler's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Proair Digihaler's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 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)
Proair Digihaler Generic API suppliers:
Albuterol Sulfate is the generic name for the brand Proair Digihaler. 46 different companies have already filed for the generic of Proair Digihaler, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Proair Digihaler's generic
Alternative Brands for Proair Digihaler
Proair Digihaler which is used for treating symptoms of depression and anxiety disorders., has several other brand drugs using the same active ingredient (Albuterol Sulfate). 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 | ||
|---|---|---|---|
| Astrazeneca |
| ||
| Boehringer Ingelheim |
| ||
| Glaxosmithkline |
| ||
| Kindeva |
| ||
| Norvium Bioscience |
| ||
| Teva Branded Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Albuterol Sulfate, Proair Digihaler's active ingredient. Check the complete list of approved generic manufacturers for Proair Digihaler
About Proair Digihaler
Proair Digihaler is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is used for treating symptoms of depression and anxiety disorders. Proair Digihaler uses Albuterol Sulfate as an active ingredient. Proair Digihaler was launched by Teva Branded Pharm in 2018.
Approval Date:
Proair Digihaler was approved by FDA for market use on 21 December, 2018.
Active Ingredient:
Proair Digihaler uses Albuterol Sulfate as the active ingredient. Check out other Drugs and Companies using Albuterol Sulfate ingredient
Treatment:
Proair Digihaler is used for treating symptoms of depression and anxiety disorders.
Dosage:
Proair Digihaler is available in powder, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.09MG BASE/INH | POWDER, METERED | Discontinued | INHALATION |