Byvalson is a drug owned by Abbvie Inc. It is protected by 2 US drug patents filed in 2016 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 04, 2027. Details of Byvalson'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). | |||
| US7838552 | Compositions comprising nebivolol |
Oct, 2027
(2 years from now) | Active |
| US7803838 | Compositions comprising nebivolol |
Aug, 2026
(1 year, 3 months 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 Byvalson's patents.
Latest Legal Activities on Byvalson's Patents
Given below is the list of recent legal activities going on the following patents of Byvalson.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Apr, 2022 | US7838552 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Feb, 2022 | US7803838 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 May, 2018 | US7838552 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Mar, 2018 | US7803838 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Nov, 2010 | US7838552 |
| Recordation of Patent Grant Mailed Critical | 23 Nov, 2010 | US7838552 |
| Email Notification Critical | 04 Nov, 2010 | US7838552 |
| Issue Notification Mailed Critical | 03 Nov, 2010 | US7838552 |
| Dispatch to FDC | 26 Oct, 2010 | US7838552 |
| Application Is Considered Ready for Issue Critical | 08 Oct, 2010 | US7838552 |
FDA has granted several exclusivities to Byvalson. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Byvalson, 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 Byvalson.
Exclusivity Information
Byvalson holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Byvalson's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Jun 03, 2019 |
US patents provide insights into the exclusivity only within the United States, but Byvalson 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 Byvalson's family patents as well as insights into ongoing legal events on those patents.
Byvalson's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Byvalson's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 04, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Byvalson Generic API suppliers:
Nebivolol Hydrochloride; Valsartan is the generic name for the brand Byvalson. 1 company has already filed for the generic of Byvalson. Check out the entire list of companies who have already received approval for Byvalson's generic
How can I launch a generic of Byvalson before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Byvalson's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Byvalson'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 Byvalson -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/80 mg | 09 Jun, 2017 | 1 | 19 Sep, 2022 | 04 Oct, 2027 | Deferred |
Alternative Brands for Byvalson
Byvalson which is used for managing high blood pressure., has several other brand drugs in the same treatment category . 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.
About Byvalson
Byvalson is a drug owned by Abbvie Inc. It is used for managing high blood pressure. Byvalson uses Nebivolol Hydrochloride; Valsartan as an active ingredient. Byvalson was launched by Abbvie in 2016.
Approval Date:
Byvalson was approved by FDA for market use on 03 June, 2016.
Active Ingredient:
Byvalson uses Nebivolol Hydrochloride; Valsartan as the active ingredient. Check out other Drugs and Companies using Nebivolol Hydrochloride; Valsartan ingredient
Treatment:
Byvalson is used for managing high blood pressure.
Dosage:
Byvalson is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE;80MG | TABLET | Discontinued | ORAL |