Qvar 40 is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is protected by 12 US drug patents filed from 2013 to 2022. Out of these, 8 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 01, 2032. Details of Qvar 40'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). | |||
| US5605674 | Medicinal aerosol formulations |
Feb, 2014
(10 years ago) |
Expired
|
| US5683677 | Medicinal aerosol formulations |
Nov, 2014
(9 years ago) |
Expired
|
| US5776432 | Beclomethasone solution aerosol formulations |
Jul, 2015
(9 years ago) |
Expired
|
| US6446627 | Inhaler dose counter |
Dec, 2017
(6 years ago) |
Expired
|
| US10695512 | Dose counter for inhaler having an anti-reverse rotation actuator |
May, 2031
(6 years from now) | Active |
| US9463289 | Dose counters for inhalers, inhalers and methods of assembly thereof |
May, 2031
(6 years from now) | Active |
| US10022509 | Dose counter for inhaler having a bore and shaft arrangement |
May, 2031
(6 years from now) | Active |
| US9808587 | 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 |
| US11395889 | Dose counter for inhaler having an anti-reverse rotation actuator |
May, 2031
(6 years from now) | Active |
| US10086156 | Dose counter for inhaler and method for counting doses |
May, 2031
(6 years from now) | Active |
| US10561808 | Dose counter for inhaler having an anti-reverse rotation actuator |
Jan, 2032
(7 years from now) | Active |
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 Qvar 40 and ongoing litigations to help you estimate the early arrival of Qvar 40 generic.
Qvar 40's Litigations
Qvar 40 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 Qvar 40's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10561808 | October, 2018 | Decision | Declan Walsh et al. | |
US patents provide insights into the exclusivity only within the United States, but Qvar 40 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 Qvar 40's family patents as well as insights into ongoing legal events on those patents.
Qvar 40's family patents
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Generic Launch
Generic Release Date:
Qvar 40's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 01, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qvar 40 Generics:
There are no approved generic versions for Qvar 40 as of now.
How can I launch a generic of Qvar 40 before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Qvar 40's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Qvar 40's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Qvar 40 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mcg/actuation and 80 mcg/actuation | 10 Jan, 2020 | 1 | 18 May, 2031 |
About Qvar 40
Qvar 40 is a drug owned by Teva Branded Pharmaceutical Products R And D Inc. It is used for treatment of hypertension, angina, and heart failure. Qvar 40 uses Beclomethasone Dipropionate as an active ingredient. Qvar 40 was launched by Teva Branded Pharm in 2000.
Market Authorisation Date:
Qvar 40 was approved by FDA for market use on 15 September, 2000.
Active Ingredient:
Qvar 40 uses Beclomethasone Dipropionate as the active ingredient. Check out other Drugs and Companies using Beclomethasone Dipropionate ingredient
Treatment:
Qvar 40 is used for treatment of hypertension, angina, and heart failure.
Dosage:
Qvar 40 is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED | Discontinued | INHALATION |