BUPIVACAINE; MELOXICAM - Generic Drug Details
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What are the generic sources for bupivacaine; meloxicam and what is the scope of patent protection?
Bupivacaine; meloxicam
is the generic ingredient in one branded drug marketed by Heron Theraps Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bupivacaine; meloxicam has eighty-one patent family members in twenty countries.
One supplier is listed for this compound.
Summary for BUPIVACAINE; MELOXICAM
| International Patents: | 81 |
| US Patents: | 16 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| DailyMed Link: | BUPIVACAINE; MELOXICAM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BUPIVACAINE; MELOXICAM
*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 BUPIVACAINE; MELOXICAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rothman Institute Orthopaedics | Phase 3 |
| TriHealth Inc. | Phase 3 |
| Baptist Health South Florida | Phase 4 |
Pharmacology for BUPIVACAINE; MELOXICAM
| Drug Class | Amide Local Anesthetic Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for BUPIVACAINE; MELOXICAM
US Patents and Regulatory Information for BUPIVACAINE; MELOXICAM
| 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 | 211988-001 | May 12, 2021 | DISCN | Yes | No | ⤷ 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 | 211988-003 | 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 | 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 | ⤷ 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 | ⤷ 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 | |||
| >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 BUPIVACAINE; MELOXICAM
| 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 BUPIVACAINE; MELOXICAM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2968111 | COMPOSITIONS D'UN POLYORTHOESTER ET D'UN SOLVANT APROTIQUE (COMPOSITIONS OF A POLYORTHOESTER AND AN APROTIC SOLVENT) | ⤷ Sign Up |
| China | 106535886 | 长效聚合物输送系统 (Long-acting polymeric delivery systems) | ⤷ Sign Up |
| Mexico | 352907 | COMPOSICIONES DE UN POLIORTOÉSTER Y UN SOLVENTE APRÓTICO. (COMPOSITIONS OF A POLYORTHOESTER AND AN APROTIC SOLVENT.) | ⤷ Sign Up |
| Mexico | 2021003558 | SISTEMAS DE SUMINISTRO POLIMERICO DE ACCION PROLONGADA. (LONG-ACTING POLYMERIC DELIVERY SYSTEMS.) | ⤷ Sign Up |
| Japan | 2019001824 | ポリオルトエステルおよび非プロトン性溶媒の組成物 (POLYORTHOESTER AND COMPOSITION OF APROTIC SOLVENT) | ⤷ Sign Up |
| Australia | 2020250230 | COMPOSITIONS OF A POLYORTHOESTER AND AN APROTIC SOLVENT | ⤷ Sign Up |
| China | 115025099 | ⤷ 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.
ISSN: 2162-2639
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