ZYNRELEF KIT Drug Patent Profile
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When do Zynrelef Kit patents expire, and when can generic versions of Zynrelef Kit launch?
Zynrelef Kit is a drug marketed by Heron Theraps Inc and is included in one NDA. There are sixteen patents protecting this drug.
This drug has eighty-one patent family members in twenty countries.
The generic ingredient in ZYNRELEF KIT is bupivacaine; meloxicam. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupivacaine; meloxicam profile page.
DrugPatentWatch® Generic Entry Outlook for Zynrelef Kit
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 20, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for ZYNRELEF KIT
| International Patents: | 81 |
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| DailyMed Link: | ZYNRELEF KIT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZYNRELEF KIT
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ZYNRELEF KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr. Yannis Raftopoulos | Phase 4 |
| Baptist Health South Florida | Phase 4 |
| Mayo Clinic | Phase 4 |
Pharmacology for ZYNRELEF KIT
| Drug Class | Amide Local Anesthetic Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Local Anesthesia |
US Patents and Regulatory Information for ZYNRELEF KIT
ZYNRELEF KIT is protected by sixteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZYNRELEF KIT is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ZYNRELEF KIT
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Compositions of a polyorthoester and an aprotic solvent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Compositions of a polyorthoester and an organic acid excipient
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Compositions of a polyorthoester and an aprotic solvent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER FOOT AND ANKLE, SMALL-TO-MEDIUM OPEN ABDOMINAL, AND LOWER EXTREMITY TOTAL JOINT ARTHROPLASTY SURGICAL PROCEDURES VIA INSTILLATION
Compositions of a polyorthoester and an aprotic solvent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Compositions of a polyorthoester and an aprotic solvent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Long-acting polymeric delivery systems
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Compositions of a polyorthoester and an aprotic solvent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
FDA Regulatory Exclusivity protecting ZYNRELEF KIT
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Heron Theraps Inc | ZYNRELEF KIT | bupivacaine; meloxicam | SOLUTION, EXTENDED RELEASE;PERIARTICULAR | 211988-004 | May 12, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Heron Theraps Inc | ZYNRELEF KIT | bupivacaine; meloxicam | SOLUTION, EXTENDED RELEASE;PERIARTICULAR | 211988-003 | May 12, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Heron Theraps Inc | ZYNRELEF KIT | bupivacaine; meloxicam | SOLUTION, EXTENDED RELEASE;PERIARTICULAR | 211988-002 | May 12, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Heron Theraps Inc | ZYNRELEF KIT | bupivacaine; meloxicam | SOLUTION, EXTENDED RELEASE;PERIARTICULAR | 211988-003 | May 12, 2021 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Heron Theraps Inc | ZYNRELEF KIT | bupivacaine; meloxicam | SOLUTION, EXTENDED RELEASE;PERIARTICULAR | 211988-004 | May 12, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ZYNRELEF KIT
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Heron Therapeutics, B.V. | Zynrelef | bupivacaine, meloxicam | EMEA/H/C/005205 Zynrelef is indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults (see section 5.1). |
Withdrawn | no | no | no | 2020-09-24 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ZYNRELEF KIT
When does loss-of-exclusivity occur for ZYNRELEF KIT?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15249949
Estimated Expiration: ⤷ Sign Up
Patent: 20207850
Estimated Expiration: ⤷ Sign Up
Patent: 23202876
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016024665
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 46281
Estimated Expiration: ⤷ Sign Up
Patent: 74824
Estimated Expiration: ⤷ Sign Up
China
Patent: 6535886
Estimated Expiration: ⤷ Sign Up
Patent: 3908284
Estimated Expiration: ⤷ Sign Up
Patent: 4886899
Estimated Expiration: ⤷ Sign Up
Patent: 5025099
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0211612
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 24575
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 34068
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 34068
Estimated Expiration: ⤷ Sign Up
Patent: 09601
Estimated Expiration: ⤷ Sign Up
Patent: 36115
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 55973
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 02882
Estimated Expiration: ⤷ Sign Up
Patent: 81248
Estimated Expiration: ⤷ Sign Up
Patent: 17513871
Patent: 長期作用性ポリマー送達系
Estimated Expiration: ⤷ Sign Up
Patent: 19526601
Patent: 送達系、アミド型局所麻酔薬、およびメロキシカムを含む医薬組成物
Estimated Expiration: ⤷ Sign Up
Patent: 20114887
Patent: 長期作用性ポリマー送達系 (LONG-ACTING POLYMERIC DELIVERY SYSTEMS)
Estimated Expiration: ⤷ Sign Up
Patent: 21138773
Patent: 送達系、アミド型局所麻酔薬、およびメロキシカムを含む医薬組成物 (DELIVERY SYSTEM, AMIDE TYPE TOPICAL ANESTHETIC AND PHARMACEUTICAL COMPOSITION INCLUDING MELOXICAM)
Estimated Expiration: ⤷ Sign Up
Patent: 22017553
Patent: 長期作用性ポリマー送達系
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 34068
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 16013719
Patent: SISTEMAS DE SUMINISTRO POLIMERICO DE ACCION PROLONGADA. (LONG-ACTING POLYMERIC DELIVERY SYSTEMS.)
Estimated Expiration: ⤷ Sign Up
Patent: 21003558
Patent: SISTEMAS DE SUMINISTRO POLIMERICO DE ACCION PROLONGADA. (LONG-ACTING POLYMERIC DELIVERY SYSTEMS.)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 34068
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 34068
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 435
Patent: DUGODELUJUĆI POLIMERNI SISTEMI ZA ISPORUKU (LONG-ACTING POLYMERIC DELIVERY SYSTEMS)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 34068
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2450730
Estimated Expiration: ⤷ Sign Up
Patent: 170005017
Patent: 장기간 작용하는 중합체 전달 시스템 (LONG-ACTING POLYMERIC DELIVERY SYSTEMS)
Estimated Expiration: ⤷ Sign Up
Patent: 220138419
Patent: 장기간 작용하는 중합체 전달 시스템 (LONG-ACTING POLYMERIC DELIVERY SYSTEMS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 93376
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 75661
Estimated Expiration: ⤷ Sign Up
Patent: 1605445
Patent: Long-acting polymeric delivery systems
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ZYNRELEF KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2019194267 | ポリオルトエステルおよび有機酸添加剤の組成物 (COMPOSITIONS OF POLYORTHOESTER AND ORGANIC ACID EXCIPIENT) | ⤷ Sign Up |
| South Korea | 102238495 | ⤷ Sign Up | |
| Australia | 2015249949 | ⤷ Sign Up | |
| China | 111956598 | 聚原酸酯和质子惰性溶剂的组合物 (Compositions of polyorthoester and aprotic solvent) | ⤷ Sign Up |
| Japan | 2019526601 | 送達系、アミド型局所麻酔薬、およびメロキシカムを含む医薬組成物 | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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