Exparel is a drug owned by Pacira Pharmaceuticals Inc. It is protected by 21 US drug patents filed from 2013 to 2024. Out of these, 16 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 02, 2044. Details of Exparel'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). | |||
| US12156940 | Manufacturing of bupivacaine multivesicular liposomes |
Jul, 2044
(19 years from now) | Active |
| US11918565 | Treatment of post-operative pain via sciatic nerve block with sustained-release liposomal anesthetic compositions |
Feb, 2043
(17 years from now) | Active |
| US11931459 | Treatment of pain in pediatric patients by administration of sustained-release liposomal anesthetic compositions |
Mar, 2042
(16 years from now) | Active |
| US11925706 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US12151024 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11179336 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11452691 | Compositions of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US12144890 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11033495 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11278494 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11819575 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11426348 | Compositions of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11357727 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11311486 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11304904 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US11819574 | Manufacturing of bupivacaine multivesicular liposomes |
Jan, 2041
(15 years from now) | Active |
| US9585838 | Production of multivesicular liposomes |
Dec, 2021
(3 years ago) |
Expired
|
| US8834921 | Sustained-release liposomal anesthetic compositions |
Sep, 2018
(6 years ago) |
Expired
|
| US8182835 | Sustained-release liposomal anesthetic compositions |
Sep, 2018
(6 years ago) |
Expired
|
| US9205052 | Sustained-release liposomal anesthetic compositions |
Sep, 2018
(6 years ago) |
Expired
|
| US6132766 | Multivesicular liposomes with controlled release of encapsulated biologically active substances |
Nov, 2013
(11 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 Exparel's patents.
Latest Legal Activities on Exparel's Patents
Given below is the list of recent legal activities going on the following patents of Exparel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent eCertificate of Correction | 02 Jul, 2024 | US11819575 |
| Mail Patent eCofC Notification | 02 Jul, 2024 | US11819575 |
| Email Notification Critical | 02 Jul, 2024 | US11819575 |
| Patent eCofC Notification | 02 Jul, 2024 | US11819575 |
| Email Notification Critical | 14 Jun, 2024 | US11819575 |
| Post Issue Communication - Certificate of Correction | 14 Jun, 2024 | US11819575 |
| Mail Certificate of Correction Memo | 13 Jun, 2024 | US11819575 |
| Certificate of Correction Memo | 11 Jun, 2024 | US11819575 |
| Electronic Review Critical | 07 Jun, 2024 | US11931459 |
| Mail Certificate of Correction Memo | 08 May, 2024 | US11931459 |
FDA has granted several exclusivities to Exparel. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Exparel, 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 Exparel.
Exclusivity Information
Exparel holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Exparel's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 28, 2014 |
| New Indication(I-771) | Apr 06, 2021 |
| New Patient Population(NPP) | Mar 22, 2024 |
| New Indication(I-929) | Nov 09, 2026 |
US patents provide insights into the exclusivity only within the United States, but Exparel 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 Exparel's family patents as well as insights into ongoing legal events on those patents.
Exparel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exparel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 02, 2044 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exparel Generic API suppliers:
Bupivacaine is the generic name for the brand Exparel. 1 company has already filed for the generic of Exparel. Check out the entire list of companies who have already received approval for Exparel's generic
How can I launch a generic of Exparel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Exparel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Exparel'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 Exparel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 133 mg/10 mL | 28 Dec, 2021 | 1 | |||
| 266 mg/20 mL | 20 Aug, 2021 | 1 | 22 Jan, 2041 |
Alternative Brands for Exparel
Exparel which is used for providing local or regional analgesia in various surgical procedures and postoperative pain management., has several other brand drugs using the same active ingredient (Bupivacaine). 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.
| Drug Owner | Drug Name | |
|---|---|---|
| Heron Theraps Inc |
| |
| Innocoll |
| |
| Innocoll Pharms |
| |
| Purdue Pharma Lp |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bupivacaine, Exparel's active ingredient. Check the complete list of approved generic manufacturers for Exparel
About Exparel
Exparel is a drug owned by Pacira Pharmaceuticals Inc. It is used for providing local or regional analgesia in various surgical procedures and postoperative pain management. Exparel uses Bupivacaine as an active ingredient. Exparel was launched by Pacira Pharms Inc in 2011.
Approval Date:
Exparel was approved by FDA for market use on 28 October, 2011.
Active Ingredient:
Exparel uses Bupivacaine as the active ingredient. Check out other Drugs and Companies using Bupivacaine ingredient
Treatment:
Exparel is used for providing local or regional analgesia in various surgical procedures and postoperative pain management.
Dosage:
Exparel is available in injectable, liposomal form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 133MG/10ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL | Prescription | INJECTION |
| 266MG/20ML (13.3MG/ML) | INJECTABLE, LIPOSOMAL | Prescription | INJECTION |