BUPIVACAINE; MELOXICAM - Generic Drug Details

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 patent family members in twenty countries.

One supplier is listed for this compound.

Summary for BUPIVACAINE; MELOXICAM

International Patents:	80
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

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 BUPIVACAINE; MELOXICAM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rothman Institute Orthopaedics	Phase 3
Baptist Health South Florida	Phase 4
TriHealth Inc.	Phase 3

See all BUPIVACAINE; MELOXICAM clinical trials

Pharmacology for BUPIVACAINE; MELOXICAM

Drug Class	Amide Local Anesthetic Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Local Anesthesia

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

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

International Patents for BUPIVACAINE; MELOXICAM

Country	Patent Number	Title	Estimated Expiration
Mexico	352907	COMPOSICIONES DE UN POLIORTOÉSTER Y UN SOLVENTE APRÓTICO. (COMPOSITIONS OF A POLYORTHOESTER AND AN APROTIC SOLVENT.)
China	106535886	长效聚合物输送系统 (Long-acting polymeric delivery systems)
Japan	2020169224	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)
European Patent Office	2968111	COMPOSITIONS D'UN POLYORTHOESTER ET D'UN SOLVANT APROTIQUE (COMPOSITIONS OF A POLYORTHOESTER AND AN APROTIC SOLVENT)
South Korea	102238495
Slovenia	3134070
Mexico	2021003558	SISTEMAS DE SUMINISTRO POLIMERICO DE ACCION PROLONGADA. (LONG-ACTING POLYMERIC DELIVERY SYSTEMS.)