Bupivacaine; meloxicam - Generic Drug Details

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What are the generic drug sources for bupivacaine; meloxicam and what is the scope of freedom to operate?

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

Generic Entry Date for bupivacaine; meloxicam^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for bupivacaine; meloxicam

US Patents and Regulatory Information for bupivacaine; meloxicam

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Glossary

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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	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	211988-003	May 12, 2021		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	⤷ 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 bupivacaine; meloxicam

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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

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Country	Patent Number	Title	Estimated Expiration
Australia	2023202876		⤷ Sign Up
Japan	2021059598	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
Japan	6723162		⤷ Sign Up
Canada	3174824	SYSTEMES D'ADMINISTRATION POLYMERES A ACTION PROLONGEE (LONG-ACTING POLYMERIC DELIVERY SYSTEMS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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