Belbuca Patent Expiration

Belbuca is a drug owned by Biodelivery Sciences International Inc. It is protected by 5 US drug patents filed from 2015 to 2018. Out of these, 3 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 21, 2032. Details of Belbuca'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).
US9901539 Transmucosal drug delivery devices for use in chronic pain relief
Dec, 2032

(8 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 Belbuca's patents.

Given below is the list of recent legal activities going on the following patents of Belbuca.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 03 Oct, 2023 US8147866 (Litigated)
Expire Patent 27 Sep, 2021 US7579019 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 27 Aug, 2021 US9901539
Maintenance Fee Reminder Mailed 12 Apr, 2021 US7579019 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 23 Nov, 2020 US9655843
Payment of Maintenance Fee, 8th Year, Large Entity 03 Oct, 2019 US8147866 (Litigated)
Post Issue Communication - Certificate of Correction 10 May, 2018 US9901539
Patent Issue Date Used in PTA Calculation 27 Feb, 2018 US9901539
Recordation of Patent Grant Mailed 27 Feb, 2018 US9901539
Review Certificate Mailed 08 Feb, 2018 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 Belbuca and ongoing litigations to help you estimate the early arrival of Belbuca generic.

Belbuca's Litigations

Belbuca 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 Belbuca's patents.

Last updated on December 3, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7579019 January, 2014 FWD Entered
(05 Aug, 2015)
Arius Two, Inc. MONOSOL RX, LLC


FDA has granted some exclusivities to Belbuca. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Belbuca, 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 Belbuca.

Exclusivity Information

Belbuca holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Belbuca's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Oct 23, 2018

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US patents provide insights into the exclusivity only within the United States, but Belbuca 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 Belbuca's family patents as well as insights into ongoing legal events on those patents.

Belbuca's Family Patents

Belbuca has patent protection in a total of 27 countries. It's US patent count contributes only to 29.2% 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 Belbuca.

Family Patents

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Generic Launch

Generic Release Date:

Belbuca's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 21, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Belbuca Generic API suppliers:

Buprenorphine Hydrochloride is the generic name for the brand Belbuca. 12 different companies have already filed for the generic of Belbuca, with Alvogen having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Belbuca's generic

How can I launch a generic of Belbuca before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Belbuca's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Belbuca'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 Belbuca -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
75 mcg and 150 mcg 24 Oct, 2016 1 23 Jul, 2027 Extinguished Non-Forfeiture
300 mcg, 450 mcg, 600 mcg and 750 mcg 04 Oct, 2016 1 23 Jul, 2027 Extinguished Non-Forfeiture
900 mcg 12 Sep, 2016 1 23 Jul, 2027 Extinguished Non-Forfeiture

Alternative Brands for Belbuca

Belbuca which is used for managing severe, long-term pain when other treatments are insufficient, through transmucosal delivery of buprenorphine., has several other brand drugs in the same treatment category and using the same active ingredient (Buprenorphine 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
Collegium Pharm Inc
Xtampza Er Used for managing severe, chronic pain when other treatment options are insufficient.
Purdue Pharma Lp
Butrans Used for chronic pain management when other treatment options are inadequate, requiring long-term around-the-clock opioid therapy.
Targiniq Used for managing severe chronic pain when alternative treatment options are inadequate, requiring daily, around-the-clock, long-term opioid treatment.
Oxycontin used for managing moderate to severe pain that requires long-term opioid treatment when other options are inadequate.
Hysingla Er used for managing severe chronic pain when other treatment options are insufficient.
Zyla
Arymo Er Used for chronic pain management when other treatment options are ineffective.

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. Buprenorphine Hydrochloride. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Bdsi
Bunavail
Indivior
Suboxone
Orexo Us Inc
Zubsolv
Reacx Pharms
Probuphine


Apart from brand drugs containing the same ingredient, some generics have also been filed for Buprenorphine Hydrochloride, Belbuca's active ingredient. Check the complete list of approved generic manufacturers for Belbuca





About Belbuca

Belbuca is a drug owned by Biodelivery Sciences International Inc. It is used for managing severe, long-term pain when other treatments are insufficient, through transmucosal delivery of buprenorphine. Belbuca uses Buprenorphine Hydrochloride as an active ingredient. Belbuca was launched by Bdsi in 2015.

Can you believe Belbuca received compensation for the extended wait time during the regulatory approval process?

A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.

Approval Date:

Belbuca was approved by FDA for market use on 23 October, 2015.

Active Ingredient:

Belbuca uses Buprenorphine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Buprenorphine Hydrochloride ingredient

Treatment:

Belbuca is used for managing severe, long-term pain when other treatments are insufficient, through transmucosal delivery of buprenorphine.

Dosage:

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

Strength Dosage Form Availability Application Pathway
EQ 0.75MG BASE FILM Prescription BUCCAL
EQ 0.45MG BASE FILM Prescription BUCCAL
EQ 0.075MG BASE FILM Prescription BUCCAL
EQ 0.15MG BASE FILM Prescription BUCCAL
EQ 0.3MG BASE FILM Prescription BUCCAL
EQ 0.6MG BASE FILM Prescription BUCCAL
EQ 0.9MG BASE FILM Prescription BUCCAL