Bunavail is a drug owned by Biodelivery Sciences International Inc. It is protected by 6 US drug patents filed from 2014 to 2017. Out of these, 4 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 24, 2035. Details of Bunavail'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). | |||
| US9522188 | Abuse resistant transmucosal drug delivery device |
Apr, 2035
(10 years from now) | Active |
| US8703177 | Abuse-resistant mucoadhesive devices for delivery of buprenorphine |
Aug, 2032
(7 years from now) | Active |
| US9655843 | Transmucosal delivery devices with enhanced uptake |
Jul, 2027
(2 years from now) | Active |
| US8147866 | Transmucosal delivery devices with enhanced uptake |
Jul, 2027
(2 years from now) | Active |
| US7579019 | Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces |
Jan, 2020
(4 years ago) |
Expired
|
| US6159498 | Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces |
Oct, 2016
(8 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 Bunavail's patents.
Latest Legal Activities on Bunavail's Patents
Given below is the list of recent legal activities going on the following patents of Bunavail.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Jun, 2024 | US9522188 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Oct, 2023 | US8147866 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Oct, 2021 | US8703177 (Litigated) |
| Expire Patent Critical | 27 Sep, 2021 | US7579019 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 12 Apr, 2021 | US7579019 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Nov, 2020 | US9655843 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jun, 2020 | US9522188 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Oct, 2019 | US8147866 (Litigated) |
| Review Certificate Mailed | 08 Feb, 2018 | US7579019 (Litigated) |
| Review Certificate | 15 Dec, 2017 | US7579019 (Litigated) |
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 Bunavail and ongoing litigations to help you estimate the early arrival of Bunavail generic.
Bunavail's Litigations
Bunavail been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 22, 2014, against patent number US7579019. The petitioner MONOSOL RX, LLC, challenged the validity of this patent, with Arius Two, Inc. as the respondent. Click below to track the latest information on how companies are challenging Bunavail's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9522188 | December, 2012 |
Decision
(29 Jan, 2016) | Andrew Finn et al | |
| US7579019 | January, 2014 |
FWD Entered
(05 Aug, 2015) | Arius Two, Inc. | MONOSOL RX, LLC |
FDA has granted some exclusivities to Bunavail. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bunavail, 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 Bunavail.
Exclusivity Information
Bunavail holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Bunavail's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 06, 2017 |
US patents provide insights into the exclusivity only within the United States, but Bunavail 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 Bunavail's family patents as well as insights into ongoing legal events on those patents.
Bunavail's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bunavail's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 24, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bunavail Generic API suppliers:
Buprenorphine Hydrochloride; Naloxone Hydrochloride is the generic name for the brand Bunavail. 15 different companies have already filed for the generic of Bunavail, with Dr Reddys Labs Sa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bunavail's generic
How can I launch a generic of Bunavail before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bunavail's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bunavail'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 Bunavail -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.1 mg/0.3 mg and 4.2 mg/0.7 mg | 23 Nov, 2016 | 1 | 20 Aug, 2032 | ||
| 6.3 mg/1 mg | 21 Dec, 2015 | 1 | 20 Aug, 2032 |
Alternative Brands for Bunavail
Bunavail which is used for managing and treating opioid dependence., has several other brand drugs using the same active ingredient (Buprenorphine Hydrochloride; Naloxone 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Buprenorphine Hydrochloride; Naloxone Hydrochloride, Bunavail's active ingredient. Check the complete list of approved generic manufacturers for Bunavail
About Bunavail
Bunavail is a drug owned by Biodelivery Sciences International Inc. It is used for managing and treating opioid dependence. Bunavail uses Buprenorphine Hydrochloride; Naloxone Hydrochloride as an active ingredient. Bunavail was launched by Bdsi in 2014.
Approval Date:
Bunavail was approved by FDA for market use on 06 June, 2014.
Active Ingredient:
Bunavail uses Buprenorphine Hydrochloride; Naloxone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Buprenorphine Hydrochloride; Naloxone Hydrochloride ingredient
Treatment:
Bunavail is used for managing and treating opioid dependence.
Dosage:
Bunavail is available in film form for buccal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 6.3MG BASE;EQ 1MG BASE | FILM | Discontinued | BUCCAL |
| EQ 2.1MG BASE;EQ 0.3MG BASE | FILM | Discontinued | BUCCAL |
| EQ 4.2MG BASE;EQ 0.7MG BASE | FILM | Discontinued | BUCCAL |