Bupivacaine; meloxicam - Generic Drug Details

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-three patent family members in twenty countries.

One supplier is listed for this compound.

Summary for bupivacaine; meloxicam

International Patents:	83
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupivacaine; meloxicam
DailyMed Link:	bupivacaine; meloxicam at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bupivacaine; meloxicam

Constraining patent/regulatory exclusivity:

10,213,510

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
Texas Tech University Health Sciences Center	EARLY_PHASE1
Rothman Institute Orthopaedics	Phase 3
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

M01AC	Oxicams
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

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	211988-003	May 12, 2021		DISCN	Yes	No	11,844,837
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes	10,980,886		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	10,898,575		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No	9,694,079		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes	11,083,730		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	9,694,079		Y

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/005205Zynrelef 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
Taiwan	I675661
Japan	2020114887
Japan	2022017553	長期作用性ポリマー送達系
Australia	2023202876	Long-acting polymeric delivery systems
Japan	2016513659	ポリオルトエステルおよび非プロトン性溶媒の組成物
South Korea	102505642

Bupivacaine; meloxicam Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Bupivacaine and Meloxicam?

Bupivacaine and meloxicam operate within distinct segments of the pharmaceutical landscape, with differing demand drivers, regulatory environments, and competitive landscapes.

Bupivacaine

Bupivacaine is a local anesthetic primarily used for surgical anesthesia, postoperative pain management, and labor analgesia. Its market has been influenced by several factors:

• Market Size and Growth: The global local anesthetics market was valued at approximately USD 3.2 billion in 2021, with bupivacaine accounting for the majority share. Compound annual growth rate (CAGR) estimates project a 4-5% increase through 2028.

• Demand Drivers:

  • Increasing procedural volume in hospitals.
  • Rising adoption of regional anesthesia techniques.
  • Growing preference for outpatient surgeries reducing hospitalization time.

• Competitive Landscape:

  • Major players include AstraZeneca (Marcaine), Hospira, and Teva.
  • Generic versions dominate the market post-patent expiries (e.g., AstraZeneca's patent expired in 2014).

• Regulatory and Safety Considerations:

  • Warnings around cardiotoxicity restrict off-label uses.
  • Approval for advanced formulations (e.g., liposomal bupivacaine) in regional blocks impacts market dynamics.

Meloxicam

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used for osteoarthritis, rheumatoid arthritis, and related conditions:

• Market Size and Growth: The global NSAIDs market was valued at approximately USD 16 billion in 2021; meloxicam-specific share is sizable due to its favorable safety profile compared to other NSAIDs.

• Demand Drivers:

  • Rising prevalence of chronic inflammatory conditions.
  • Aging populations increasing demand for long-term pain management.
  • Shift toward prescription NSAIDs over off-label or OTC options.

• Competitive Landscape:

  • Key competitors include celecoxib, ibuprofen, and naproxen.
  • Patents on meloxicam composition have expired; generic versions are widely available, diluting brand premiums.
  • Market share remains stable for branded formulations like Mobic, but generics dominate.

• Regulatory and Safety Considerations:

  • NSAID-associated gastrointestinal and cardiovascular risks influence prescribing patterns.
  • Label warnings reduce off-label misuse.

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How Do Regulatory Policies Impact Market Trajectories?

Bupivacaine

• Patent expiries facilitated generic proliferation, reducing costs and expanding access.
• Ongoing development of extended-release formulations seeks to extend market share.
• Regulatory guidance emphasizes safety, particularly around cardiotoxicity, influencing clinical adoption.

Meloxicam

• Patent expiration in the early 2010s increased generic uptake.
• Safety warnings around increased cardiovascular risk for long-term NSAID use influence prescriber behavior.
• Innovative formulations (e.g., delayed-release tablets) approved by regulators aim to improve tolerability.

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What Are Financial Trends and Investment Considerations?

Revenue and Sales Trends

Product	2021 Market Value	Expected CAGR (2022-2028)	Key Notes
Bupivacaine	USD 2.4 billion	4-5%	Generics dominate, with growth driven by procedural volume.
Meloxicam	USD 2.2 billion	3-4%	Market steady, with growth aligned to chronic disease prevalence.

Investment Opportunities and Risks

• Bupivacaine:

  • Opportunities in advanced formulations and regional administration devices.
  • Risks include safety concerns and potential regulatory restrictions.

• Meloxicam:

  • Opportunities in new delivery systems that mitigate adverse effects.
  • Risks include competition from other NSAIDs and safety-related prescribing limits.

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How Do Competitive Strategies Shape Future Market Outlook?

• Dominance of generics limits profit margins but ensures consistent sales volume for both drugs.
• Investment in formulations that improve safety or efficacy can create niche market advantages.
• Strategic alliances and licensing deals expand geographic reach.

Key Market Drivers Summary

• Growing procedural volume boosts bupivacaine demand.
• Increasing prevalence of chronic inflammatory diseases sustains meloxicam sales.
• Patent expirations intensified competition but opened access to generics.
• Safety concerns and regulatory guidance influence product development and marketing strategies.

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Key Takeaways

• Bupivacaine’s market is characterized by steady growth driven by procedural demand and innovation in formulations.
• Meloxicam benefits from chronic disease management needs but faces regulatory safety hurdles.
• Generics dominate, constraining margins but ensuring consistent volume.
• Safety and efficacy are primary focus areas influencing competitive differentiation.
• Investment in new delivery platforms offers growth potential amid mature markets.

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FAQs

Q1: How has patent expiry affected bupivacaine's market?
A1: Patent expiry led to a surge in generic versions, reducing prices and expanding accessibility but decreasing profitability for brand owners.

Q2: What are the main safety concerns for meloxicam?
A2: Long-term use may increase gastrointestinal bleeding and cardiovascular risks, influencing prescribing guidelines.

Q3: Which regions show the highest growth prospects for these drugs?
A3: Emerging markets in Asia-Pacific and Latin America offer growth due to expanding healthcare infrastructure and procedural volume.

Q4: Are there emerging formulations that could disrupt the market?
A4: Yes. Extended-release formulations for bupivacaine and formulations reducing NSAID-related toxicity are under development.

Q5: How do regulatory agencies impact the competitive landscape?
A5: Regulatory guidance around safety, approval of generics, and formulation standards influence market entry, product innovation, and pricing strategies.

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Sources:

1. MarketWatch Reports on Local Anesthetics and NSAIDs, 2022.
2. GlobalData Pharma Analysis, 2022.
3. U.S. FDA Drug Approvals and Safety Communications, 2022.
4. IQVIA National Sales Perspectives, 2021.
5. Company filings and patent databases.