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
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 |
|---|---|---|---|---|
| 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 |
| 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 | 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 | Braeburn |
| Brixadi | US8545832 | Lipid depot formulations | Jun 06, 2025 | Braeburn |
| 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 |
| 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 |
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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 May, 2024 | US9498432 |
| Recordation of Patent eGrant | 12 Dec, 2023 | US11839611 |
| Patent eGrant Notification | 12 Dec, 2023 | US11839611 |
| Recordation of Patent Grant Mailed Critical | 12 Dec, 2023 | US11839611 |
| Email Notification Critical | 12 Dec, 2023 | US11839611 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Dec, 2023 | US11839611 |
| Mail Patent eGrant Notification | 12 Dec, 2023 | US11839611 |
| Email Notification Critical | 23 Nov, 2023 | US11839611 |
| Issue Notification Mailed Critical | 22 Nov, 2023 | US11839611 |
| Application Is Considered Ready for Issue Critical | 07 Nov, 2023 | US11839611 |
Buprenorphine's Family Patents
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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 Alvogen Inc 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.
1. 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 |
Manufacturing Plant Locations New
Alvogen's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Alvogen as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
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 |
Manufacturing Plant Locations New
Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||||||||||
| India |
| |||||||||||||||||
3. DIFGEN PHARMS
Difgen 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 Difgen Pharms.
| 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 |
4. 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 |
5. 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 |