Buprenorphine Hydrochloride; Naloxone Hydrochloride Patent Expiration

Buprenorphine Hydrochloride; Naloxone Hydrochloride is used for treating opioid dependence and opioid use disorder. It was first introduced by Indivior Inc in its drug Suboxone on Oct 8, 2002. Other drugs containing Buprenorphine Hydrochloride; Naloxone Hydrochloride are Bunavail, Zubsolv, Cassipa. 18 different companies have introduced drugs containing Buprenorphine Hydrochloride; Naloxone Hydrochloride.


Buprenorphine Hydrochloride; Naloxone Hydrochloride Patents

Given below is the list of patents protecting Buprenorphine Hydrochloride; Naloxone Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Bunavail US9522188 Abuse resistant transmucosal drug delivery device Apr 24, 2035 Bdsi
Zubsolv US10874661 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence Sep 18, 2032 Orexo Us Inc
Zubsolv US10946010 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence Sep 18, 2032 Orexo Us Inc
Zubsolv US11020387 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence Sep 18, 2032 Orexo Us Inc
Zubsolv US11020388 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence Sep 18, 2032 Orexo Us Inc
Zubsolv US11433066 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence Sep 18, 2032 Orexo Us Inc
Zubsolv US8940330 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence Sep 18, 2032 Orexo Us Inc
Zubsolv US9259421 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence Sep 18, 2032 Orexo Us Inc
Zubsolv US9439900 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence Sep 18, 2032 Orexo Us Inc
Bunavail US8703177 Abuse-resistant mucoadhesive devices for delivery of buprenorphine Aug 20, 2032 Bdsi
Zubsolv US8470361 Non-abusable pharmaceutical composition comprising opioids May 22, 2030 Orexo Us Inc
Suboxone US8475832 Sublingual and buccal film compositions Mar 26, 2030 Indivior
Suboxone US11135216 Sublingual and buccal film compositions Aug 07, 2029 Indivior
Suboxone US9687454 Sublingual and buccal film compositions Aug 07, 2029 Indivior
Zubsolv US8658198 Non-abusable pharmaceutical composition comprising opioids Dec 03, 2027 Orexo Us Inc
Bunavail US8147866 Transmucosal delivery devices with enhanced uptake Jul 23, 2027 Bdsi
Bunavail US9655843 Transmucosal delivery devices with enhanced uptake Jul 23, 2027 Bdsi
Suboxone US8603514 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Apr 03, 2024

(Expired)

Indivior
Suboxone US8017150 Polyethylene oxide-based films and drug delivery systems made therefrom Feb 13, 2023

(Expired)

Indivior
Suboxone US10285910 Sublingual and buccal film compositions Oct 11, 2022

(Expired)

Indivior
Suboxone US9855221 Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions Feb 14, 2022

(Expired)

Indivior
Suboxone US9931305 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Feb 14, 2022

(Expired)

Indivior
Bunavail US7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces Jan 22, 2020

(Expired)

Bdsi
Zubsolv US8454996 Pharmaceutical composition for the treatment of acute disorders Sep 24, 2019

(Expired)

Orexo Us Inc
Bunavail US6159498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces Oct 18, 2016

(Expired)

Bdsi



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 Buprenorphine Hydrochloride; Naloxone Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Buprenorphine Hydrochloride; Naloxone Hydrochloride.

Activity Date Patent Number
Patent litigations
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)
Expire Patent 19 Jun, 2023 US10285910
Maintenance Fee Reminder Mailed 02 Jan, 2023 US10285910
Review Certificate Mailed 30 Sep, 2022 US9687454(Litigated)
Review Certificate 23 Sep, 2022 US9687454(Litigated)
Recordation of Patent Grant Mailed 06 Sep, 2022 US11433066
Patent Issue Date Used in PTA Calculation 06 Sep, 2022 US11433066
Email Notification 18 Aug, 2022 US11433066


Buprenorphine Hydrochloride; Naloxone Hydrochloride's Family Patents

Family Patents

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Buprenorphine Hydrochloride; Naloxone Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Buprenorphine Hydrochloride; Naloxone Hydrochloride. The first generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride was by Amneal Pharmaceuticals Of New York Llc and was approved on Feb 22, 2013. And the latest generic version is by Difgen Pharmaceuticals Llc and was approved on Feb 13, 2025.

Given below is the list of companies who have filed for Buprenorphine Hydrochloride; Naloxone Hydrochloride generic, along with the locations of their manufacturing plants worldwide.