Proventil-hfa is a drug owned by Kindeva Drug Delivery Lp. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 28, 2016. Details of Proventil-hfa'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). | |||
| US6006745 | Device for delivering an aerosol |
Dec, 2016
(7 years ago) |
Expired
|
| US5775321 | Seal configuration for aerosol canister |
Jul, 2015
(9 years ago) |
Expired
|
| US5605674 | Medicinal aerosol formulations |
Feb, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Proventil-hfa 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 Proventil-hfa's family patents as well as insights into ongoing legal events on those patents.
Proventil-hfa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Proventil-hfa's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 28, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Proventil-hfa Generic API suppliers:
Albuterol Sulfate is the generic name for the brand Proventil-hfa. 46 different companies have already filed for the generic of Proventil-hfa, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Proventil-hfa's generic
How can I launch a generic of Proventil-hfa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Proventil-hfa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Proventil-hfa'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 Proventil-hfa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.09 mg base per actuation | 20 May, 2015 | 1 | 28 Dec, 2016 | Extinguished |
Alternative Brands for Proventil-hfa
There are several other brand drugs using the same active ingredient (Albuterol Sulfate) as Proventil-hfa. 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 |
| |||
| Norvium Bioscience |
| |||
| Teva Branded Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Albuterol Sulfate, Proventil-hfa's active ingredient. Check the complete list of approved generic manufacturers for Proventil-hfa
About Proventil-hfa
Proventil-Hfa is a drug owned by Kindeva Drug Delivery Lp. Proventil-Hfa uses Albuterol Sulfate as an active ingredient. Proventil-Hfa was launched by Kindeva in 1996.
Approval Date:
Proventil-hfa was approved by FDA for market use on 15 August, 1996.
Active Ingredient:
Proventil-hfa uses Albuterol Sulfate as the active ingredient. Check out other Drugs and Companies using Albuterol Sulfate ingredient
Dosage:
Proventil-hfa is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.09MG BASE/INH | AEROSOL, METERED | Prescription | INHALATION |