Suboxone is a drug owned by Indivior Inc. It is protected by 8 US drug patents filed from 2013 to 2021. Out of these, 3 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 26, 2030. Details of Suboxone'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). | |||
| US8475832 | Sublingual and buccal film compositions |
Mar, 2030
(5 years from now) | Active |
| US11135216 | Sublingual and buccal film compositions |
Aug, 2029
(4 years from now) | Active |
| US9687454 | Sublingual and buccal film compositions |
Aug, 2029
(4 years from now) | Active |
| US8603514 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
Apr, 2024
(8 months ago) |
Expired
|
| US8017150 | Polyethylene oxide-based films and drug delivery systems made therefrom |
Feb, 2023
(1 year, 10 months ago) |
Expired
|
| US10285910 | Sublingual and buccal film compositions |
Oct, 2022
(2 years ago) |
Expired
|
| US9855221 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
Feb, 2022
(2 years ago) |
Expired
|
| US9931305 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
Feb, 2022
(2 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 Suboxone's patents.
Latest Legal Activities on Suboxone's Patents
Given below is the list of recent legal activities going on the following patents of Suboxone.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 19 Jun, 2023 | US10285910 |
| Maintenance Fee Reminder Mailed Critical | 02 Jan, 2023 | US10285910 |
| Review Certificate Mailed | 30 Sep, 2022 | US9687454 (Litigated) |
| Review Certificate | 23 Sep, 2022 | US9687454 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 05 Oct, 2021 | US11135216 |
| Recordation of Patent Grant Mailed Critical | 05 Oct, 2021 | US11135216 |
| Email Notification Critical | 16 Sep, 2021 | US11135216 |
| Issue Notification Mailed Critical | 15 Sep, 2021 | US11135216 |
| Application Is Considered Ready for Issue Critical | 10 Sep, 2021 | US11135216 |
| Dispatch to FDC | 10 Sep, 2021 | US11135216 |
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 Suboxone and ongoing litigations to help you estimate the early arrival of Suboxone generic.
Suboxone's Litigations
Suboxone been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 20, 2014, against patent number US8475832. The petitioner BioDelivery Sciences International, Inc., challenged the validity of this patent, with RB Pharmaceuticals Limited as the respondent. Click below to track the latest information on how companies are challenging Suboxone's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9687454 | November, 2018 |
FWD Entered
(02 Jun, 2020) | Indivior UK Limited | Dr. Reddy’s Laboratories S.A. |
| US9687454 | November, 2018 |
Terminated-Denied
(03 Jun, 2019) | Indivior UK Limited | Dr. Reddy's Laboratories S.A. |
| US8603514 | June, 2017 |
Terminated-Denied
(20 Oct, 2017) | MonoSol Rx, LLC | Par Pharmaceutical, Inc. |
| US8603514 | June, 2017 |
Terminated-Denied
(20 Oct, 2017) | MonoSol Rx, LLC | Dr. Reddy’s Laboratories, Inc. |
| US8603514 | November, 2016 |
Terminated-Settled
(06 Oct, 2017) | MonoSol Rx, LLC et al. | Mylan Technologies, Inc. et al. |
| US8017150 | May, 2016 |
Terminated-Denied
(05 Dec, 2016) | MonoSol Rx, LLC | Dr. Reddy’s Laboratories, Inc. |
| US8603514 | May, 2016 |
Terminated-Denied
(05 Dec, 2016) | MonoSol Rx, LLC | Dr. Reddy's Laboratories, Inc. |
| US8475832 | May, 2016 |
Terminated-Denied
(02 Dec, 2016) | Indivior UK Limited | Dr. Reddy’s Laboratories, Inc. |
| US8475832 | December, 2015 |
Terminated-Denied
(10 Jun, 2016) | Indivior UK Limited | Teva Pharmaceuticals USA, Inc. |
| US8017150 | December, 2015 |
Terminated-Denied
(23 May, 2016) | MONOSOL RX, LLC | Teva Parmaceuticals USA Inc. |
| US8603514 | December, 2015 |
Terminated-Denied
(23 May, 2016) | MONOSOL RX LLC | Teva Pharmaceuticals USA Inc |
| US8475832 | January, 2014 |
FWD Entered
(30 Jun, 2015) | RB Pharmaceuticals Limited | BioDelivery Sciences International, Inc. |
| US8475832 | June, 2014 |
Terminated-Denied
(19 Dec, 2014) | RB Pharmaceuticals Limited | BioDelivery Sciences International, Inc. |
FDA has granted some exclusivities to Suboxone. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Suboxone, 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 Suboxone.
Exclusivity Information
Suboxone holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Suboxone's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Aug 30, 2013 |
Several oppositions have been filed on Suboxone's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Suboxone's generic, the next section provides detailed information on ongoing and past EP oppositions related to Suboxone patents.
Suboxone's Oppositions Filed in EPO
Suboxone has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 11, 2012, by Lts Lohmann Therapie-Systeme Ag. This opposition was filed on patent number EP02801042A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP10740493A | Oct, 2016 | LTS LOHMANN Therapie-Systeme AG | Patent maintained as amended |
| EP11157819A | Jun, 2014 | Ahrens, Gabriele | Patent maintained as amended |
| EP02782151A | Jun, 2013 | Acino Pharma AG | Revoked |
| EP02782151A | Jun, 2013 | Germann, Sandra | Revoked |
| EP02801042A | Sep, 2012 | Ahrens, Gabriele | Patent maintained as amended |
| EP02801042A | Sep, 2012 | LTS LOHMANN Therapie-Systeme AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Suboxone 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 Suboxone's family patents as well as insights into ongoing legal events on those patents.
Suboxone's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Suboxone's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 26, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Suboxone Generic API suppliers:
Buprenorphine Hydrochloride; Naloxone Hydrochloride is the generic name for the brand Suboxone. 15 different companies have already filed for the generic of Suboxone, 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 Suboxone's generic
How can I launch a generic of Suboxone before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Suboxone's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Suboxone'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 Suboxone -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg/vial | 26 Jan, 2009 | 2 | 24 Mar, 2009 | 31 Jul, 2018 | Eligible |
| 2 mg/0.5 mg* and 8 mg/2 mg | 15 Oct, 2012 | 1 | 13 Feb, 2023 | Extinguished | |
| 4 mg/1 mg | 14 May, 2013 | 1 | 13 Feb, 2023 | Extinguished | |
| 12 mg/3 mg | 14 May, 2013 | 1 | 13 Feb, 2023 | Extinguished |
Alternative Brands for Suboxone
Suboxone which is used for treating opioid dependence and opioid use disorder., has several other brand drugs in the same treatment category and 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.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Indivior |
| |||
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; Naloxone Hydrochloride. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Buprenorphine Hydrochloride; Naloxone Hydrochloride, Suboxone's active ingredient. Check the complete list of approved generic manufacturers for Suboxone
About Suboxone
Suboxone is a drug owned by Indivior Inc. It is used for treating opioid dependence and opioid use disorder. Suboxone uses Buprenorphine Hydrochloride; Naloxone Hydrochloride as an active ingredient. Suboxone was launched by Indivior in 2010.
Approval Date:
Suboxone was approved by FDA for market use on 30 August, 2010.
Active Ingredient:
Suboxone uses Buprenorphine Hydrochloride; Naloxone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Buprenorphine Hydrochloride; Naloxone Hydrochloride ingredient
Treatment:
Suboxone is used for treating opioid dependence and opioid use disorder.
Dosage:
Suboxone is available in film form for buccal, sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2MG BASE;EQ 0.5MG BASE | FILM | Prescription | BUCCAL, SUBLINGUAL |
| EQ 8MG BASE;EQ 2MG BASE | FILM | Prescription | BUCCAL, SUBLINGUAL |
| EQ 4MG BASE;EQ 1MG BASE | FILM | Prescription | BUCCAL, SUBLINGUAL |
| EQ 12MG BASE;EQ 3MG BASE | FILM | Prescription | BUCCAL, SUBLINGUAL |