Sublocade is a drug owned by Indivior Inc. It is protected by 13 US drug patents filed from 2018 to 2026 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 22, 2038. Details of Sublocade'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). | |||
| US10646484 | Methods to treat opioid use disorder |
Jun, 2038
(11 years from now) | Active |
| US12622904 | Buprenorphine Dosing Regimens |
Nov, 2035
(9 years from now) | Active |
| US11000520 | Buprenorphine dosing regimens |
Nov, 2035
(9 years from now) | Active |
| US11839611 | Buprenorphine dosing regimens |
Nov, 2035
(9 years from now) | Active |
| US8921387 | Injectable flowable composition comprising buprenorphine |
Jan, 2032
(5 years from now) | Active |
| US8975270 | Injectable flowable composition comprising buprenorphine |
Sep, 2031
(4 years from now) | Active |
| US10558394 | Injectable flowable composition comprising buprenorphine |
Jun, 2031
(4 years from now) | Active |
| US9827241 | Injectable flowable composition comprising buprenorphine |
Jun, 2031
(4 years from now) | Active |
| US9272044 | Injectable flowable composition buprenorphine |
Jun, 2031
(4 years from now) | Active |
| US9498432 | Injectable flowable composition comprising buprenorphine |
Jun, 2031
(4 years from now) | Active |
| US10592168 | Injectable flowable composition comprising buprenorphine |
Jun, 2031
(4 years from now) | Active |
| US9782402 | Injectable composition comprising buprenorphine |
Jun, 2031
(4 years from now) | Active |
| US10198218 | Injectable flowable composition comprising buprenorphine |
Jun, 2031
(4 years from now) | Active |
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 Sublocade's patents.
Latest Legal Activities on Sublocade's Patents
Given below is the list of recent legal activities going on the following patents of Sublocade.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2025 | US9827241 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Apr, 2025 | US9782402 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Sep, 2024 | US11000520 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 May, 2024 | US9498432 |
| Patent Issue Date Used in PTA Calculation
Critical | 12 Dec, 2023 | US11839611 |
| Recordation of Patent eGrant | 12 Dec, 2023 | US11839611 |
| Mail Patent eGrant Notification | 12 Dec, 2023 | US11839611 |
| Email Notification
Critical | 12 Dec, 2023 | US11839611 |
| Patent eGrant Notification | 12 Dec, 2023 | US11839611 |
| Recordation of Patent Grant Mailed
Critical | 12 Dec, 2023 | US11839611 |
FDA has granted several exclusivities to Sublocade. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Sublocade, 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
Sublocade.
Exclusivity Information
Sublocade holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Sublocade's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 30, 2020 |
| M(M-314) | Feb 21, 2028 |
Several oppositions have been filed on Sublocade'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 Sublocade's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Sublocade patents.
Sublocade's Oppositions Filed in EPO
Sublocade has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 10, 2018, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP11728037A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15828368A | Mar, 2021 | ELKINGTON AND FIFE LLP | Granted and Under Opposition |
| EP11728037A | Oct, 2018 | Teva Pharmaceutical Industries Ltd. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but
Sublocade 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 Sublocade's family patents as well as insights into
ongoing legal events
on those patents.
Sublocade's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Sublocade:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Sublocade's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 22, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sublocade Generic API suppliers:
Buprenorphine is the generic name for the brand Sublocade. 5 different companies have already filed for the generic of Sublocade, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sublocade's generic
Alternative Brands for Sublocade
Sublocade which is used for opioid addiction and dependence, including treatment of opioid use disorder., has several other brand drugs in the same treatment category and using the same active ingredient (Buprenorphine). 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. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Bdsi |
| ||
| Braeburn |
| ||
| Edenbridge Pharms |
| ||
| Knoa Pharma |
| ||
| Reacx Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Buprenorphine, Sublocade's active ingredient. Check the complete list of approved generic manufacturers for Sublocade
About Sublocade
Sublocade is a drug owned by Indivior Inc. It is used for opioid addiction and dependence, including treatment of opioid use disorder. Sublocade uses Buprenorphine as an active ingredient. Sublocade was launched by Indivior in 2017.
Approval Date:
Sublocade was approved by FDA for market use on 30 November, 2017.
Active Ingredient:
Sublocade uses Buprenorphine as the active ingredient. Check out other Drugs and Companies using Buprenorphine ingredient
Treatment:
Sublocade is used for opioid addiction and dependence, including treatment of opioid use disorder.
Dosage:
Sublocade is available in solution, extended release form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG/1.5ML (200MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |
| 100MG/0.5ML (100MG/0.5ML) | SOLUTION, EXTENDED RELEASE | Prescription | SUBCUTANEOUS |