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
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 |
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
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 |