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Last Updated: March 29, 2024

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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 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:80
US Patents:16
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 4
Formulation / Manufacturing:see details
DailyMed Link:ZYNRELEF KIT at DailyMed
Drug patent expirations by year for ZYNRELEF KIT
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZYNRELEF KIT
Generic Entry Date for ZYNRELEF KIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION, EXTENDED RELEASE;PERIARTICULAR

*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

SponsorPhase
Dr. Yannis RaftopoulosPhase 4
Baptist Health South FloridaPhase 4
Mayo ClinicPhase 4

See all ZYNRELEF KIT clinical trials

Pharmacology for ZYNRELEF KIT

US Patents and Regulatory Information for ZYNRELEF KIT

ZYNRELEF KIT is protected by sixteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZYNRELEF KIT is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Long-acting polymeric delivery systems
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Long-acting polymeric delivery systems
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Long-acting polymeric delivery systems
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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 211988-003 May 12, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heron Theraps Inc ZYNRELEF KIT bupivacaine; meloxicam SOLUTION, EXTENDED RELEASE;PERIARTICULAR 211988-002 May 12, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Heron Theraps Inc ZYNRELEF KIT bupivacaine; meloxicam SOLUTION, EXTENDED RELEASE;PERIARTICULAR 211988-003 May 12, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Heron Theraps Inc ZYNRELEF KIT bupivacaine; meloxicam SOLUTION, EXTENDED RELEASE;PERIARTICULAR 211988-004 May 12, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 20207850
Estimated Expiration: ⤷  Try a Trial

Patent: 23202876
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2016024665
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 46281
Estimated Expiration: ⤷  Try a Trial

Patent: 74824
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6535886
Estimated Expiration: ⤷  Try a Trial

Patent: 3908284
Estimated Expiration: ⤷  Try a Trial

Patent: 4886899
Estimated Expiration: ⤷  Try a Trial

Patent: 5025099
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0211612
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 24575
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 34068
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 34068
Estimated Expiration: ⤷  Try a Trial

Patent: 09601
Estimated Expiration: ⤷  Try a Trial

Patent: 36115
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 55973
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 02882
Estimated Expiration: ⤷  Try a Trial

Patent: 81248
Estimated Expiration: ⤷  Try a Trial

Patent: 17513871
Estimated Expiration: ⤷  Try a Trial

Patent: 19526601
Estimated Expiration: ⤷  Try a Trial

Patent: 20114887
Estimated Expiration: ⤷  Try a Trial

Patent: 21138773
Estimated Expiration: ⤷  Try a Trial

Patent: 22017553
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 34068
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 16013719
Estimated Expiration: ⤷  Try a Trial

Patent: 21003558
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 34068
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 34068
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 435
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 34068
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2450730
Estimated Expiration: ⤷  Try a Trial

Patent: 170005017
Estimated Expiration: ⤷  Try a Trial

Patent: 220138419
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 93376
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 75661
Estimated Expiration: ⤷  Try a Trial

Patent: 1605445
Estimated Expiration: ⤷  Try a Trial

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
China 114886899 长效聚合物输送系统 (Long-acting polymer delivery system) ⤷  Try a Trial
South Korea 102450730 ⤷  Try a Trial
European Patent Office 3134068 SYSTÈMES D'ADMINISTRATION POLYMÈRES À ACTION PROLONGÉE (LONG-ACTING POLYMERIC DELIVERY SYSTEMS) ⤷  Try a Trial
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) ⤷  Try a Trial
>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.