Bunavail Patent Expiration

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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6159498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces
Oct, 2016

(7 years ago)

US7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces
Jan, 2020

(4 years ago)

US9655843 Transmucosal delivery devices with enhanced uptake
Jul, 2027

(3 years from now)

US8147866 Transmucosal delivery devices with enhanced uptake
Jul, 2027

(3 years from now)

US8703177 Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Aug, 2032

(8 years from now)

US9522188 Abuse resistant transmucosal drug delivery device
Apr, 2035

(10 years from now)


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 has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 04, 2012, against patent number US9522188. The petitioner , challenged the validity or infringement of this patent, with Andrew Finn et al 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
Patent litigations
US9522188 December, 2012 Decision Andrew Finn et al

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

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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

Bunavail has patent protection in a total of 26 countries. It's US patent count contributes only to 37.4% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Bunavail.

Family Patents

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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 Generics:

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

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.

Market Authorisation 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


Bunavail is used for managing and treating opioid dependence.


Bunavail is available in film form for buccal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway