Proair Respiclick Patent Expiration

Proair Respiclick is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 18 US drug patents filed from 2015 to 2021. Out of these, 11 drug patents are active and 7 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 28, 2035. Details of Proair Respiclick'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).
US9782550 Compliance monitoring module for a breath-actuated inhaler
Aug, 2035

(10 years from now)

Active
US9782551 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
US10124131 Dose counter for inhaler having an anti-reverse rotation actuator
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
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

(7 months from now)

Active
US9463288 Dry powder inhalation apparatus
May, 2025

(7 months from now)

Active
US7540282 Reservoir pressure system for medicament inhaler
May, 2023

(1 year, 5 months 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
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
US6446627 Inhaler dose counter
Dec, 2017

(6 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 Respiclick's patents.

Given below is the list of recent legal activities going on the following patents of Proair Respiclick.

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
Expire Patent 02 Oct, 2023 US8006690
Payment of Maintenance Fee, 4th Year, Large Entity 20 Jul, 2023 US10561808
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 08 Sep, 2022 US8978966
Payment of Maintenance Fee, 4th Year, Large Entity 04 May, 2022 US10124131
Payment of Maintenance Fee, 4th Year, Large Entity 14 Jan, 2022 US10022510
Payment of Maintenance Fee, 8th Year, Large Entity 11 Aug, 2021 US8651103


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 Respiclick and ongoing litigations to help you estimate the early arrival of Proair Respiclick generic.

Proair Respiclick's Litigations

Proair Respiclick 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 Respiclick's patents.

Last updated on October 1, 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 Proair Respiclick. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Proair Respiclick, 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 Proair Respiclick.

Exclusivity Information

Proair Respiclick holds 2 exclusivities. All of its exclusivities have expired in 2019. Details of Proair Respiclick's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Mar 12, 2018
New Patient Population(NPP) Apr 28, 2019

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Several oppositions have been filed on Proair Respiclick'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 Respiclick's generic, the next section provides detailed information on ongoing and past EP oppositions related to Proair Respiclick patents.

Proair Respiclick's Oppositions Filed in EPO

Proair Respiclick 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
EP19155324A Jun, 2021 Vectura Limited Granted and Under Opposition
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 Respiclick 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 Respiclick's family patents as well as insights into ongoing legal events on those patents.

Proair Respiclick's Family Patents

Proair Respiclick has patent protection in a total of 31 countries. It's US patent count contributes only to 16.3% of its total global patent coverage. 7 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 Proair Respiclick.

Family Patents

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Generic Launch

Generic Release Date:

Proair Respiclick's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 28, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Proair Respiclick Generics:

Albuterol Sulfate is the generic name for the brand Proair Respiclick. 46 different companies have already filed for the generic of Proair Respiclick, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Proair Respiclick's generic

Alternative Brands for Proair Respiclick

There are several other brand drugs using the same active ingredient (Albuterol Sulfate) as Proair Respiclick. 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
Airsupra
Boehringer Ingelheim
Combivent
Combivent Respimat
Glaxosmithkline
Ventolin Hfa
Kindeva
Proventil-hfa
Norvium Bioscience
Accuneb
Duoneb
Teva Branded Pharm
Proair Digihaler
Proair Hfa


Apart from brand drugs containing the same ingredient, some generics have also been filed for Albuterol Sulfate, Proair Respiclick's active ingredient. Check the complete list of approved generic manufacturers for Proair Respiclick





About Proair Respiclick

Proair Respiclick is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. Proair Respiclick uses Albuterol Sulfate as an active ingredient. Proair Respiclick was launched by Teva Branded Pharm in 2018.

Approval Date:

Proair Respiclick was approved by FDA for market use on 21 December, 2018.

Active Ingredient:

Proair Respiclick uses Albuterol Sulfate as the active ingredient. Check out other Drugs and Companies using Albuterol Sulfate ingredient

Dosage:

Proair Respiclick 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 Prescription INHALATION