Zubsolv is a drug owned by Orexo Us Inc. It is protected by 11 US drug patents filed from 2013 to 2022. Out of these, 10 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 18, 2032. Details of Zubsolv'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). | |||
| US8940330 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Sep, 2032
(6 years from now) | Active |
| US9259421 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Sep, 2032
(6 years from now) | Active |
| US9439900 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Sep, 2032
(6 years from now) | Active |
| US10946010 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Sep, 2032
(6 years from now) | Active |
| US11020388 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Sep, 2032
(6 years from now) | Active |
| US11433066 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Sep, 2032
(6 years from now) | Active |
| US11020387 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Sep, 2032
(6 years from now) | Active |
| US10874661 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence |
Sep, 2032
(6 years from now) | Active |
| US8470361 | Non-abusable pharmaceutical composition comprising opioids |
May, 2030
(4 years from now) | Active |
| US8658198 | Non-abusable pharmaceutical composition comprising opioids |
Dec, 2027
(2 years from now) | Active |
| US8454996 | Pharmaceutical composition for the treatment of acute disorders |
Sep, 2019
(6 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 Zubsolv's patents.
Latest Legal Activities on Zubsolv's Patents
Given below is the list of recent legal activities going on the following patents of Zubsolv.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Jun, 2024 | US10874661 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Mar, 2024 | US9439900 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Aug, 2023 | US9259421 (Litigated) |
| Recordation of Patent Grant Mailed
Critical | 06 Sep, 2022 | US11433066 |
| Patent Issue Date Used in PTA Calculation
Critical | 06 Sep, 2022 | US11433066 |
| Email Notification
Critical | 18 Aug, 2022 | US11433066 |
| Issue Notification Mailed
Critical | 17 Aug, 2022 | US11433066 |
| Application Is Considered Ready for Issue
Critical | 28 Jul, 2022 | US11433066 |
| Dispatch to FDC | 28 Jul, 2022 | US11433066 |
| Issue Fee Payment Received
Critical | 26 Jul, 2022 | US11433066 |
FDA has granted several exclusivities to Zubsolv. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Zubsolv, 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
Zubsolv.
Exclusivity Information
Zubsolv holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Zubsolv's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-713) | Aug 10, 2018 |
Several oppositions have been filed on Zubsolv'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 Zubsolv's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Zubsolv patents.
Zubsolv's Oppositions Filed in EPO
Zubsolv has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 06, 2014, by Generics [Uk] Limited. This opposition was filed on patent number EP07824784A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12775283A | Dec, 2015 | Generics (U.K.) Limited | Opposition procedure closed |
| EP07824784A | Aug, 2014 | Generics [UK] Limited | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but
Zubsolv 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 Zubsolv's family patents as well as insights into
ongoing legal events
on those patents.
Zubsolv's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zubsolv's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 18, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zubsolv Generic API suppliers:
Buprenorphine Hydrochloride; Naloxone Hydrochloride is the generic name for the brand Zubsolv. 15 different companies have already filed for the generic of Zubsolv, 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 Zubsolv's generic
How can I launch a generic of Zubsolv before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zubsolv's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zubsolv'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 Zubsolv -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.4 mg/0.36 mg and 5.7 mg/1.4 mg | 22 Oct, 2013 | 1 | 22 May, 2030 | ||
| 8.6 mg/2.1 mg and 11.4 mg/2.9 mg | 24 Jul, 2015 | 1 | 18 Sep, 2032 | ||
| 2.9 mg/7.1 mg | 21 Dec, 2015 | 1 | 18 Sep, 2032 | ||
| 0.7 mg/0.18 mg | 04 May, 2017 | 1 | 18 Sep, 2032 |
Alternative Brands for Zubsolv
Zubsolv which is used for treating opioid dependence., has several other brand drugs 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Buprenorphine Hydrochloride; Naloxone Hydrochloride, Zubsolv's active ingredient. Check the complete list of approved generic manufacturers for Zubsolv
About Zubsolv
Zubsolv is a drug owned by Orexo Us Inc. It is used for treating opioid dependence. Zubsolv uses Buprenorphine Hydrochloride; Naloxone Hydrochloride as an active ingredient. Zubsolv was launched by Orexo Us Inc in 2016.
Approval Date:
Zubsolv was approved by FDA for market use on 04 October, 2016.
Active Ingredient:
Zubsolv uses Buprenorphine Hydrochloride; Naloxone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Buprenorphine Hydrochloride; Naloxone Hydrochloride ingredient
Treatment:
Zubsolv is used for treating opioid dependence.
Dosage:
Zubsolv is available in tablet form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1.4MG BASE;EQ 0.36MG BASE | TABLET | Prescription | SUBLINGUAL |
| EQ 0.7MG BASE;EQ 0.18MG BASE | TABLET | Prescription | SUBLINGUAL |
| EQ 5.7MG BASE;EQ 1.4MG BASE | TABLET | Prescription | SUBLINGUAL |
| EQ 8.6MG BASE;EQ 2.1MG BASE | TABLET | Prescription | SUBLINGUAL |
| EQ 2.9MG BASE;EQ 0.71MG BASE | TABLET | Prescription | SUBLINGUAL |
| EQ 11.4MG BASE;EQ 2.9MG BASE | TABLET | Prescription | SUBLINGUAL |