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 Purdue Pharma Lp in its drug Butrans on Jun 30, 2010. Other drugs containing Buprenorphine are Sublocade, Brixadi. 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.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
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 US8236292 Liquid depot formulations Jan 10, 2027 Braeburn
Brixadi US8236755 Opioid depot formulations Jul 31, 2026 Braeburn
Brixadi US8545832 Lipid depot formulations Jun 06, 2025 Braeburn
Brixadi US9937164 Opioid formulations Jul 26, 2032 Braeburn
Butrans US6264980 Transdermal resorption of active substances from supercooled masses of levulic acid Dec 18, 2015

(Expired)

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

(Expired)

Purdue Pharma Lp
Butrans US9642850 Method of providing sustained analgesia with buprenorphine Sep 29, 2017

(Expired)

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

(Expired)

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

(Expired)

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

(Expired)

Purdue Pharma Lp
Sublocade US10198218 Injectable flowable composition comprising buprenorphine Jun 06, 2031 Indivior
Sublocade US10558394 Injectable flowable composition comprising buprenorphine Jun 25, 2031 Indivior
Sublocade US10592168 Injectable flowable composition comprising buprenorphine Jun 06, 2031 Indivior
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 US8921387 Injectable flowable composition comprising buprenorphine Jan 06, 2032 Indivior
Sublocade US8975270 Injectable flowable composition comprising buprenorphine Sep 05, 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


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Buprenorphine Generics

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 Alvogen Inc and was approved on Mar 21, 2023.

Given below is the list of companies who have filed for Buprenorphine generic.


1. WATSON LABS TEVA

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 5 different strengths of generic version for Buprenorphine. Given below are the details of the strengths of this generic introduced by Watson Labs Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15MCG/HR film, extended release Prescription TRANSDERMAL AB Nov 20, 2018
20MCG/HR film, extended release Prescription TRANSDERMAL AB Nov 20, 2018
5MCG/HR film, extended release Prescription TRANSDERMAL AB Nov 20, 2018
10MCG/HR film, extended release Prescription TRANSDERMAL AB Nov 20, 2018
7.5MCG/HR film, extended release Prescription TRANSDERMAL AB Jun 29, 2021


2. AMNEAL

Amneal Pharmaceuticals Llc has filed for 5 different strengths of generic version for Buprenorphine. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MCG/HR film, extended release Prescription TRANSDERMAL AB Apr 14, 2020
5MCG/HR film, extended release Prescription TRANSDERMAL AB Apr 14, 2020
7.5MCG/HR film, extended release Prescription TRANSDERMAL AB Apr 14, 2020
10MCG/HR film, extended release Prescription TRANSDERMAL AB Apr 14, 2020
15MCG/HR film, extended release Prescription TRANSDERMAL AB Apr 14, 2020


3. ALVOGEN

Alvogen Inc has filed for 5 different strengths of generic version for Buprenorphine. Given below are the details of the strengths of this generic introduced by Alvogen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MCG/HR film, extended release Prescription TRANSDERMAL AB May 17, 2022
15MCG/HR film, extended release Prescription TRANSDERMAL AB May 17, 2022
20MCG/HR film, extended release Prescription TRANSDERMAL AB May 17, 2022
5MCG/HR film, extended release Prescription TRANSDERMAL AB May 17, 2022
7.5MCG/HR film, extended release Discontinued TRANSDERMAL N/A Mar 21, 2023


4. AVEVA

Aveva Drug Delivery Systems Inc has filed for 5 different strengths of generic version for Buprenorphine. Given below are the details of the strengths of this generic introduced by Aveva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7.5MCG/HR film, extended release Prescription TRANSDERMAL AB Sep 23, 2021
5MCG/HR film, extended release Prescription TRANSDERMAL AB Sep 23, 2021
20MCG/HR film, extended release Prescription TRANSDERMAL AB Sep 23, 2021
15MCG/HR film, extended release Prescription TRANSDERMAL AB Sep 23, 2021
10MCG/HR film, extended release Prescription TRANSDERMAL AB Sep 23, 2021


5. MYLAN TECH VIATRIS

Mylan Technologies Inc A Viatris Co has filed for 5 different strengths of generic version for Buprenorphine. Given below are the details of the strengths of this generic introduced by Mylan Tech Viatris.

Strength Dosage Form Availability Application Pathway TE code Launch Date
15MCG/HR film, extended release Discontinued TRANSDERMAL N/A May 3, 2021
20MCG/HR film, extended release Discontinued TRANSDERMAL N/A May 3, 2021
5MCG/HR film, extended release Discontinued TRANSDERMAL N/A May 3, 2021
7.5MCG/HR film, extended release Discontinued TRANSDERMAL N/A May 3, 2021
10MCG/HR film, extended release Discontinued TRANSDERMAL N/A May 3, 2021