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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Oct, 2023 | US8147866 (Litigated) |
| Expire Patent Critical | 27 Sep, 2021 | US7579019 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Aug, 2021 | US9901539 |
| 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, 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 Critical | 27 Feb, 2018 | US9901539 |
| Recordation of Patent Grant Mailed Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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
Explore Our Curated Drug Screens
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 |
| |||||||||
| Purdue Pharma Lp |
| |||||||||
| Zyla |
| |||||||||
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 |
| |
| Indivior |
| |
| Orexo Us Inc |
| |
| Reacx Pharms |
|
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 |