Buprenorphine Patent Expiration

Buprenorphine is Used for chronic pain management when other treatment options are inadequate, requiring long-term around-the-clock opioid therapy. It was first introduced by Knoa Pharma Llc in its drug Butrans on Jun 30, 2010. Other drugs containing Buprenorphine are Brixadi, Sublocade. 8 different companies have introduced drugs containing Buprenorphine.


Buprenorphine Patents

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

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Sublocade US10646484 Methods to treat opioid use disorder Jun 22, 2038 Indivior
Sublocade US11000520 Buprenorphine dosing regimens Nov 06, 2035 Indivior
Sublocade US11839611 Buprenorphine dosing regimens Nov 06, 2035 Indivior
Sublocade US12622904 Buprenorphine Dosing Regimens Nov 06, 2035 Indivior
Brixadi US10912772 Opioid formulations Jul 26, 2032 Braeburn
Brixadi US11110084 Opioid formulations Jul 26, 2032 Braeburn
Brixadi US11135215 Opioid formulations Jul 26, 2032 Braeburn
Brixadi US12161640 Opioid formulations Jul 26, 2032 Braeburn
Brixadi US12318379 Opioid Formulations Jul 26, 2032 Braeburn
Brixadi US9937164 Opioid formulations Jul 26, 2032 Braeburn
Sublocade US8921387 Injectable flowable composition comprising buprenorphine Jan 06, 2032 Indivior
Sublocade US8975270 Injectable flowable composition comprising buprenorphine Sep 05, 2031 Indivior
Sublocade US10558394 Injectable flowable composition comprising buprenorphine Jun 25, 2031 Indivior
Sublocade US10198218 Injectable flowable composition comprising buprenorphine Jun 06, 2031 Indivior
Sublocade US10592168 Injectable flowable composition comprising buprenorphine Jun 06, 2031 Indivior
Sublocade US9272044 Injectable flowable composition buprenorphine Jun 06, 2031 Indivior
Sublocade US9498432 Injectable flowable composition comprising buprenorphine Jun 06, 2031 Indivior
Sublocade US9782402 Injectable composition comprising buprenorphine Jun 06, 2031 Indivior
Sublocade US9827241 Injectable flowable composition comprising buprenorphine Jun 06, 2031 Indivior
Brixadi US8236292 Liquid depot formulations Jan 10, 2027 Braeburn
Brixadi US8236755 Opioid depot formulations Jul 31, 2026

(Expired)

Braeburn
Brixadi US8545832 Lipid depot formulations Jun 06, 2025

(Expired)

Braeburn
Butrans US9642850 Method of providing sustained analgesia with buprenorphine Sep 29, 2017

(Expired)

Knoa Pharma
Butrans USRE41408 Method of providing sustained analgesia with buprenorpine Sep 29, 2017

(Expired)

Knoa Pharma
Butrans USRE41489 Method of providing sustained analgesia with buprenorphine Sep 29, 2017

(Expired)

Knoa Pharma
Butrans USRE41571 Method of providing sustained analgesia with buprenorphine Sep 29, 2017

(Expired)

Knoa Pharma
Butrans US6264980 Transdermal resorption of active substances from supercooled masses of levulic acid Dec 18, 2015

(Expired)

Knoa Pharma
Butrans US6344211 Transdermal absorption of active substances from subcooled melts Dec 18, 2015

(Expired)

Knoa Pharma



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's patents.

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

Activity Date Patent Number
Patent litigations
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 12 Dec, 2023 US11839611
Recordation of Patent eGrant 12 Dec, 2023 US11839611
Mail Patent eGrant Notification 12 Dec, 2023 US11839611
Email Notification 12 Dec, 2023 US11839611
Patent eGrant Notification 12 Dec, 2023 US11839611
Recordation of Patent Grant Mailed 12 Dec, 2023 US11839611


About Veterinary Buprenorphine

Buprenorphine is used in drugs marketed by 2 different companies: Elanco Us Inc, Zoetis Inc.

Other drugs containing Buprenorphine are: Zorbium , Simbadol .

Veterinary Buprenorphine Patents

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

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Drug Used In Drug Patent Number Drug Patent Expiry Drug Owner
Patent Data
Simbadol US9168251 ZOETIS INC.

Buprenorphine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Buprenorphine:

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.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE) Washington University School of Medicine NA COMPLETED
(Sep 1, 2026)
PHASE3
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder Proniras Corporation NA RECRUITING
(Sep 1, 2026)
PHASE1
Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine VA Office of Research and Development NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Brenipatide in Participants With Opioid Use Disorder Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE2
Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder Johns Hopkins University NA COMPLETED
(Aug 1, 2026)
PHASE2
Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder Frances R Levin NA COMPLETED
(Aug 1, 2026)
PHASE2
Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl Johns Hopkins University NA COMPLETED
(Aug 1, 2026)
PHASE2
Evaluating Buspirone to Treat Opioid Withdrawal University of Maryland, Baltimore NA RECRUITING
(Aug 1, 2026)
PHASE2
GLP-1R Agonist Treatment for Opioid Use Disorder Milton S. Hershey Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE2
Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine University of Wisconsin, Madison NA RECRUITING
(Jul 1, 2026)
PHASE1
Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) NYU Langone Health NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED) Rutgers, The State University of New Jersey NA RECRUITING
(Jul 1, 2026)
PHASE3
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Virginia Commonwealth University NA COMPLETED
(Jul 1, 2026)
PHASE1, PHASE2
Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder Johns Hopkins University NA RECRUITING
(Jul 1, 2026)
PHASE2
Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl University of Maryland, Baltimore NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use University of Pennsylvania NA RECRUITING
(Jul 1, 2026)
PHASE2
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy Brigham and Women's Hospital NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine Boehringer Ingelheim NA TERMINATED
(Jul 1, 2026)
PHASE1
Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder University of Minnesota NA RECRUITING
(Jul 1, 2026)
PHASE1
Smartphones for Opiate Addiction Recovery NYU Langone Health NA RECRUITING
(Jun 1, 2026)
PHASE3
Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects Virginia Commonwealth University NA RECRUITING
(Jun 1, 2026)
PHASE2
Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial Montefiore Medical Center NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Buprenorphine Group Medical Visits in Primary Care Montefiore Medical Center NA COMPLETED
(May 1, 2026)
PHASE3
Medication Treatment for Opioid Use Disorder in Expectant Mothers T. John Winhusen, PhD NA COMPLETED
(May 1, 2026)
PHASE3
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD National Institute on Drug Abuse (NIDA) NA TERMINATED
(May 1, 2026)
PHASE2
Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans Pharmacotherapies for Alcohol and Substance Use Disorders Alliance NA COMPLETED
(May 1, 2026)
PHASE2
Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine Friends Research Institute, Inc. NA COMPLETED
(May 1, 2026)
PHASE2, PHASE3
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder New York State Psychiatric Institute NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Cannabidiol in the Treatment of Opioid Use Disorder Yasmin Hurd NA COMPLETED
(May 1, 2026)
PHASE2
Buprenorphine for Individuals in Jail Friends Research Institute, Inc. NA RECRUITING
(May 1, 2026)
PHASE3
Standard Versus High Dose ED-Initiated Buprenorphine Induction Yale University NA RECRUITING
(May 1, 2026)
PHASE3
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder T. John Winhusen, PhD NA RECRUITING
(May 1, 2026)
PHASE2
Opiate Suicide Study in Patients With Major Depression Stanford University NA COMPLETED
(Apr 1, 2026)
PHASE3
Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail Friends Research Institute, Inc. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Clinical Trials of Multivalent Opioid Vaccine Components New York State Psychiatric Institute NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual New York State Psychiatric Institute NA WITHDRAWN
(Apr 1, 2026)
PHASE2
Sublingual Dexmedetomidine for Treating Opioid Withdrawal New York State Psychiatric Institute NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia University of California, Los Angeles NA RECRUITING
(Apr 1, 2026)
PHASE2
Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) Yih-Ing Hser NA COMPLETED
(Apr 1, 2026)
PHASE3
Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department The Cooper Health System NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Telemedicine XR-B for Individuals in Jail Friends Research Institute, Inc. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 University of Pennsylvania NA TERMINATED
(Mar 1, 2026)
PHASE2


Buprenorphine Generic API Manufacturers

Several generic applications have been filed for Buprenorphine. The first generic version for Buprenorphine was by Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc and was approved on Nov 20, 2018. And the latest generic version is by Strides Pharma International Ag and was approved on Mar 21, 2023.

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