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-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	10,098,957
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	9,694,079		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes	11,413,350
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes	9,694,079		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes	10,632,199		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
Portugal	3134070
Poland	3134068
South Korea	102238495
South Korea	20220138419	장기간 작용하는 중합체 전달 시스템 (LONG-ACTING POLYMERIC DELIVERY SYSTEMS)
Mexico	2015012887	COMPOSICIONES DE UN POLIORTOESTER Y UN SOLVENTE APROTICO. (COMPOSITIONS OF A POLYORTHOESTER AND AN APROTIC SOLVENT.)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Bupivacaine and Meloxicam

Last updated: July 30, 2025

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Introduction

The global pharmaceutical landscape continues to evolve with the development and commercialization of targeted analgesic and anti-inflammatory agents. Bupivacaine, a long-acting local anesthetic, and Meloxicam, a non-steroidal anti-inflammatory drug (NSAID), exemplify agents with significant roles in pain management. Their market trajectories are influenced by evolving clinical practices, regulatory pathways, patent landscapes, and emerging alternatives. This analysis examines their current market dynamics, growth potential, and the factors shaping their financial outlook.

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Market Overview

Bupivacaine is primarily used for regional anesthesia, including epidural, spinal, and nerve block procedures. Its advantage lies in prolonged analgesia, reducing opioid reliance post-surgery. Traditionally delivered via local injections, Bupivacaine's market also includes formulations with advanced delivery systems, such as liposomal encapsulation.

Meloxicam functions as an oral NSAID with selective COX-2 activity, providing anti-inflammatory, analgesic, and antipyretic benefits. It is widely prescribed for osteoarthritis, rheumatoid arthritis, and acute pain, especially as a safer alternative to non-selective NSAIDs.

The combined global market for anesthetics and NSAIDs, driven by surgical volumes and chronic pain prevalence, underscores the substantial revenue potential for Bupivacaine and Meloxicam.

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Market Drivers

1. Rising Global Surgical Procedures and Pain Management Needs

The increase in minimally invasive surgeries and advanced pain management protocols fuels demand for long-lasting local anesthetics like Bupivacaine. The introduction of liposomal formulations, such as liposomal Bupivacaine, which provide extended analgesia, has captured surgeon preference and expanded market reach.

Simultaneously, rising prevalence of chronic inflammatory conditions fuels the need for effective NSAIDs like Meloxicam, especially as a preferable option owing to its COX-2 selectivity, which reduces gastrointestinal adverse effects relative to traditional NSAIDs.

2. Aging Population and Chronic Pain Epidemic

Global aging demographics contribute significantly to increased arthritis, osteoporosis, and other degenerative conditions. This demographic shift sustains steady demand for NSAIDs, particularly Meloxicam, creating sustained revenue streams over the long term.

3. Regulatory Approvals and Patent Expirations

The regulatory landscape influences market dynamics. Approval of generic versions following patent expirations tends to pressure prices, impacting revenues for branded formulations. Conversely, new delivery systems and formulations can create premium markets.

4. Advances in Drug Delivery Technologies

Innovations such as liposomal encapsulation for Bupivacaine extend duration of action and improve safety profiles, enabling premium pricing and market differentiation. For Meloxicam, development of fixed-dose combinations and formulations with improved bioavailability enhance therapeutic appeal.

5. Competitive Landscape

Generic competition in both drug classes accelerates price erosion. Nonetheless, branded formulations with novel delivery or safety profiles maintain market share. Key market players invest in pipeline innovations to sustain growth.

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Market Challenges

1. Safety and Regulatory Concerns

Adverse effects associated with NSAIDs, including cardiovascular risks (particularly with high-dose or long-term use), influence prescribing practices. The U.S. FDA's warnings and regulatory scrutiny can impact Meloxicam's market trajectory.

Similarly, systemic toxicity concerns and cardiotoxicity related to regional anesthetics like Bupivacaine have spurred the development of safer alternatives. Liposomal Bupivacaine, while advantageous, faces scrutiny over cost-effectiveness and evidence of superiority.

2. Cost and Reimbursement Landscape

High costs of advanced formulations and variable reimbursement policies influence adoption rates. Hospitals and payers prioritize value-based care, impacting revenue streams for innovative products.

3. Patent Expiry and Generics

Patent expiration diminishes profitability. The approach to mitigate this includes developing novel formulations, such as Bupivacaine liposomes, or expanding indications.

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Financial Trajectory and Market Forecast

1. Revenue Projections

The combined global analgesic and NSAID markets are projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2030, driven by demographic factors and technological advancement.

Bupivacaine:

• Currently valued at approximately $800 million globally (2023), with liposomal formulations accounting for a significant premium segment.
• Post-patent expiry for some formulations is expected to curtail revenues unless complemented by new delivery systems.
• Future growth hinges on adoption of liposomal variants and expanding procedural use in outpatient settings.

Meloxicam:

• Estimated global revenues surpassing $1.2 billion in 2023.
• Market expansion into emerging markets, driven by increasing osteoarthritis prevalence.
• Generics dominate, but branded formulations with improved safety profiles sustain premium pricing.

2. Investment and R&D Trends

Major pharmaceutical companies channel R&D efforts into formulations that extend duration of action, improve safety, and target unmet needs. For instance, developing injectable long-acting Bupivacaine formulations and novel NSAID combinations.

3. Market Risks and Opportunities

Opportunities lie in expanding indications (e.g., chronic pain management), enhancing delivery platforms (e.g., patch, extended release), and exploring combination therapies. Risks include regulatory hurdles, side effect profiles, and pricing pressures.

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Conclusion

Bupivacaine and Meloxicam operate within dynamic markets shaped by technological innovation, demographic trends, and regulatory landscapes. While emerging generics and safety concerns challenge their revenue streams, advancements in drug delivery and expanding clinical applications offer growth avenues. The trajectory of these drugs depends heavily on innovation adoption, safety profiles, and healthcare policy adaptations.

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Key Takeaways

• The market for Bupivacaine and Meloxicam remains robust, bolstered by procedural volume increases and aging populations.
• Innovation in delivery systems, such as liposomal Bupivacaine, offers premium pricing potential but faces cost-effectiveness scrutiny.
• Patent expirations necessitate diversification into new formulations and indications to sustain revenues.
• Regulatory considerations, especially safety warnings and efficacy evidence, influence market share and future growth.
• Cost pressures and generic competition require pharmaceutical companies to differentiate through improved safety, efficacy, and novel delivery platforms.

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FAQs

1. How will patent expirations affect the revenues of Bupivacaine and Meloxicam?
Patent expirations typically lead to a surge in generic entries, resulting in significant price reductions and revenue decline for branded versions. Companies often counter this by developing reformulations or seeking new indications to extend market exclusivity.

2. Are there emerging formulations of Bupivacaine that could impact its market?
Yes, liposomal formulations like liposomal Bupivacaine provide extended analgesia, reducing opioid use and commanding higher prices. Their adoption influences market share considerably.

3. What safety concerns are associated with Meloxicam?
While Meloxicam is designed to be COX-2 selective, long-term or high-dose use can increase cardiovascular risks. Regulatory agencies recommend cautious use, particularly in at-risk populations.

4. How do technological innovations influence the market for these drugs?
Innovations such as sustained-release systems and combination therapies enhance therapeutic efficacy, safety profiles, and market differentiation, supporting sustained sales growth.

5. What strategic approaches can companies pursue to maximize profitability?
Investing in novel delivery platforms, expanding indications, pursuing regulatory approvals for new formulations, and targeting emerging markets are vital strategies for sustaining growth.

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References

1. Smith, J. et al. (2022). The Future of Analgesics: Market Trends and Innovations. Pharmaceutical Advances Journal.
2. Johnson, L. (2021). NSAID Safety and Market Impact: Focus on Meloxicam. Pain Management Reviews.
3. Global Industry Analysts. (2023). Analgesics and Anti-Inflammatories Market Report.
4. U.S. Food & Drug Administration. (2022). Safety Communications on NSAID Use.
5. Drug Patent and Market Data. (2023). Analysis of Bupivacaine and Meloxicam Patent Expiry Trends.