Zynrelef Kit is a drug owned by Heron Therapeutics Inc. It is protected by 16 US drug patents filed from 2021 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 21, 2036. Details of Zynrelef Kit'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9592227 | Compositions of a polyorthoester and an aprotic solvent |
Mar, 2034
(9 years from now) | Active |
| US9913909 | Compositions of a polyorthoester and an aprotic solvent |
Mar, 2034
(9 years from now) | Active |
| US11253504 | Compositions of a polyorthoester and an aprotic solvent |
Mar, 2034
(9 years from now) | Active |
| US9744163 | Compositions of a polyorthoester and an aprotic solvent |
Mar, 2034
(9 years from now) | Active |
| US10398686 | Compositions of a polyorthoester and an aprotic solvent |
Mar, 2034
(9 years from now) | Active |
| US10632199 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US10898575 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US11083797 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US10980886 | Compositions of a polyorthoester and an organic acid excipient |
Apr, 2035
(10 years from now) | Active |
| US11083730 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US11413350 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US9694079 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US9801945 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US10213510 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US10098957 | Long-acting polymeric delivery systems |
Apr, 2035
(10 years from now) | Active |
| US11844837 | Compositions of a polyorthoester and an organic acid excipient |
Apr, 2036
(11 years from now) | Active |
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 Zynrelef Kit's patents.
Latest Legal Activities on Zynrelef Kit's Patents
Given below is the list of recent legal activities going on the following patents of Zynrelef Kit.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Email Notification | 20 Dec, 2023 | US11844837 |
| Patent Issue Date Used in PTA Calculation | 19 Dec, 2023 | US11844837 |
| Mail Patent eGrant Notification | 19 Dec, 2023 | US11844837 |
| Patent eGrant Notification | 19 Dec, 2023 | US11844837 |
| Recordation of Patent eGrant | 19 Dec, 2023 | US11844837 |
| Recordation of Patent Grant Mailed | 19 Dec, 2023 | US11844837 |
| Email Notification | 30 Nov, 2023 | US11844837 |
| Issue Notification Mailed | 29 Nov, 2023 | US11844837 |
| Application Is Considered Ready for Issue | 15 Nov, 2023 | US11844837 |
| Dispatch to FDC | 15 Nov, 2023 | US11844837 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Zynrelef Kit and ongoing litigations to help you estimate the early arrival of Zynrelef Kit generic.
Zynrelef Kit's Litigations
Zynrelef Kit has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 23, 2019, against patent number US10898575. The petitioner , challenged the validity or infringement of this patent, with Heron Therapeutics, Inc. as the respondent. Click below to track the latest information on how companies are challenging Zynrelef Kit's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11083730 | May, 2020 | Decision | Heron Therapeutics, Inc. | |
| US11083797 | May, 2020 | Decision | Heron Therapeutics, Inc. | |
| US10898575 | December, 2019 | Decision | Heron Therapeutics, Inc. | |
FDA has granted some exclusivities to Zynrelef Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zynrelef Kit, 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 Zynrelef Kit.
Exclusivity Information
Zynrelef Kit holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Zynrelef Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 12, 2024 |
| New Indication(I-933) | Jan 23, 2027 |
US patents provide insights into the exclusivity only within the United States, but Zynrelef Kit 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 Zynrelef Kit's family patents as well as insights into ongoing legal events on those patents.
Zynrelef Kit's family patents
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Generic Launch
Generic Release Date:
Zynrelef Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 21, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zynrelef Kit Generics:
There are no approved generic versions for Zynrelef Kit as of now.
About Zynrelef Kit
Zynrelef Kit is a drug owned by Heron Therapeutics Inc. It is used for postoperative pain management in various surgical procedures. Zynrelef Kit uses Bupivacaine; Meloxicam as an active ingredient. Zynrelef Kit was launched by Heron Theraps Inc in 2021.
Market Authorisation Date:
Zynrelef Kit was approved by FDA for market use on 12 May, 2021.
Active Ingredient:
Zynrelef Kit uses Bupivacaine; Meloxicam as the active ingredient. Check out other Drugs and Companies using Bupivacaine; Meloxicam ingredient
Treatment:
Zynrelef Kit is used for postoperative pain management in various surgical procedures.
Dosage:
Zynrelef Kit is available in solution, extended release form for periarticular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML) | SOLUTION, EXTENDED RELEASE | Discontinued | PERIARTICULAR |
| 200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | PERIARTICULAR |
| 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML) | SOLUTION, EXTENDED RELEASE | Prescription | PERIARTICULAR |
| 60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) | SOLUTION, EXTENDED RELEASE | Discontinued | PERIARTICULAR |