Bystolic is a drug owned by Allergan Sales Llc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Bystolic's patents have been open to challenges since 18 December, 2011. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 17, 2021. Details of Bystolic'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). | |||
| US6545040 | Method of lowering the blood pressure |
Dec, 2021
(2 years ago) |
Expired
|
| US5759580 | Compositions containing micronized nebivolol |
Jun, 2015
(9 years ago) |
Expired
|
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 Bystolic and ongoing litigations to help you estimate the early arrival of Bystolic generic.
Bystolic's Litigations
Bystolic been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 12, 1996, against patent number US6545040. The petitioner , challenged the validity of this patent, with XHONNEUX et al as the respondent. Click below to track the latest information on how companies are challenging Bystolic's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6545040 | December, 2015 |
Terminated-Denied
(01 Jul, 2016) | Forest Laboratories Holdings Limited | Lower Drug Prices For Consumers, LLC |
| US6545040 | June, 1996 |
Decision
(14 Mar, 2000) | XHONNEUX et al | |
FDA has granted some exclusivities to Bystolic. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bystolic, 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 Bystolic.
Exclusivity Information
Bystolic holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Bystolic's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 17, 2012 |
US patents provide insights into the exclusivity only within the United States, but Bystolic 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 Bystolic's family patents as well as insights into ongoing legal events on those patents.
Bystolic's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bystolic's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 17, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bystolic Generic API suppliers:
Nebivolol Hydrochloride is the generic name for the brand Bystolic. 17 different companies have already filed for the generic of Bystolic, with Watson Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bystolic's generic
How can I launch a generic of Bystolic before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bystolic's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bystolic'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 Bystolic -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg, 5 mg, 10 mg, and 20 mg | 19 Dec, 2011 | 7 | 16 Apr, 2015 | 17 Dec, 2021 | Eligible |
Alternative Brands for Bystolic
Bystolic which is used for treating high blood pressure., has several other brand drugs in the same treatment category and using the same active ingredient (Nebivolol Hydrochloride). 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 | Treatment Area | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott |
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| Abbvie |
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| Adhera |
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| Ani Pharms |
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| Azurity |
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| Boehringer Ingelheim |
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| Cosette |
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| Noden Pharma |
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| Novartis |
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| Upjohn |
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| Waylis Therap |
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Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Nebivolol Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Nebivolol Hydrochloride, Bystolic's active ingredient. Check the complete list of approved generic manufacturers for Bystolic
About Bystolic
Bystolic is a drug owned by Allergan Sales Llc. It is used for treating high blood pressure. Bystolic uses Nebivolol Hydrochloride as an active ingredient. Bystolic was launched by Allergan in 2007.
Approval Date:
Bystolic was approved by FDA for market use on 17 December, 2007.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Bystolic is 17 December, 2007, its NCE-1 date is estimated to be 18 December, 2011.
Active Ingredient:
Bystolic uses Nebivolol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Nebivolol Hydrochloride ingredient
Treatment:
Bystolic is used for treating high blood pressure.
Dosage:
Bystolic is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 2.5MG BASE | TABLET | Prescription | ORAL |