ZYNRELEF KIT Drug Patent Profile

When do Zynrelef Kit patents expire, and when can generic versions of Zynrelef Kit launch?

Zynrelef Kit is a drug marketed by Heron Theraps Inc and is included in one NDA. There are sixteen patents protecting this drug.

This drug has eighty-three patent family members in twenty countries.

The generic ingredient in ZYNRELEF KIT is bupivacaine; meloxicam. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupivacaine; meloxicam profile page.

DrugPatentWatch^® Generic Entry Outlook for Zynrelef Kit

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 20, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZYNRELEF KIT

International Patents:	83
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYNRELEF KIT
DailyMed Link:	ZYNRELEF KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZYNRELEF KIT

Constraining patent/regulatory exclusivity:

10,213,510

NDA:

211988

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 ZYNRELEF KIT

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

Sponsor	Phase
University of Miami	PHASE4
Texas Tech University Health Sciences Center	EARLY_PHASE1
Dr. Yannis Raftopoulos	Phase 4

See all ZYNRELEF KIT clinical trials

Pharmacology for ZYNRELEF KIT

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

US Patents and Regulatory Information for ZYNRELEF KIT

ZYNRELEF KIT is protected by sixteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,213,510.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	211988-002	May 12, 2021		RX	Yes	Yes	10,398,686		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	10,980,886		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 ZYNRELEF KIT

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 ZYNRELEF KIT

When does loss-of-exclusivity occur for ZYNRELEF KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZYNRELEF KIT around the world.

Country	Patent Number	Title	Estimated Expiration
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)
Australia	2019202415
European Patent Office	3134068	SYSTÈMES D'ADMINISTRATION POLYMÈRES À ACTION PROLONGÉE (LONG-ACTING POLYMERIC DELIVERY SYSTEMS)
World Intellectual Property Organization (WIPO)	2015164283

Market Dynamics and Financial Trajectory for ZYNRELEF KIT

Last updated: July 27, 2025

Introduction

ZYNRELEF KIT, a combination drug comprising bupivacaine and meloxicam, represents a significant innovation in the realm of surgical pain management. Introduced by Heron Therapeutics, Inc., ZYNRELEF aims to provide an opioid-sparing, long-lasting analgesic solution designed for infiltration into surgical sites, including soft tissue and incisions. As the pharmaceutical landscape shifts toward multimodal analgesia with reduced opioid dependence, understanding the market dynamics and financial trajectory of ZYNRELEF is paramount for investors, healthcare providers, and stakeholders.

This analysis explores the evolving market environment, competitive landscape, regulatory considerations, pricing strategies, and revenue forecasts shaping ZYNRELEF's commercial pathway. It distills data-driven insights to inform strategic decision-making within the burgeoning postoperative pain management segment.

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1. Market Overview and Industry Landscape

1.1 Growing Postoperative Pain Management Market

The surgical analgesics market is projected to expand at a compounded annual growth rate (CAGR) of approximately 6-8% through 2028, driven by an increasing volume of surgical procedures globally (Grand View Research, 2022). The shift away from opioids, toward multimodal and non-opioid pain therapies, is a core trend aligning with the opioid crisis mitigation strategies.

1.2 Key Drivers of Market Demand

• Opioid Reduction Initiatives: Regulatory agencies and healthcare systems incentivize opioid-sparing techniques, boosting demand for local anesthetics and non-opioid analgesics like ZYNRELEF®.
• Surgical Procedure Volume: Enhanced recovery protocols and minimally invasive surgeries increase the need for effective local anesthesia options.
• Patient Preference: Growing awareness of opioid-related adverse effects incentivizes acceptance of alternative, sustained-release formulations.

1.3 Regulatory Status and Market Authorization

ZYNRELEF obtained FDA approval in 2021 for postoperative pain management in specific surgical settings, including open inguinal hernia repair. Its approval covers a broad, strategic indication for infiltration at the surgical site, facilitating applications across multiple surgical procedures.

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2. Competitive Landscape

2.1 Major Competitors and Alternatives

• Single-agent local anesthetics: Bupivacaine, ropivacaine, lidocaine—widely used but with limited duration.
• Other multimodal formulations: Exparel (liposomal bupivacaine) by Pacira Biosciences offers extended analgesia for postoperative pain, competing directly with ZYNRELEF.
• Non-opioid alternatives: NSAIDs, acetaminophen, and emerging nerve block techniques.

2.2 Differentiation Factors

ZYNRELEF distinguishes itself through its combination of a local anesthetic (bupivacaine) with an NSAID (meloxicam), providing prolonged pain relief with reduced opioid use. Its dual-action approach appeals to providers seeking comprehensive postoperative analgesia with favorable safety profiles.

2.3 Market Penetration Challenges

• Pricing and Reimbursement: Premium pricing for advanced formulations may hinder rapid adoption unless justified by clinical and economic benefits.
• Physician Familiarity: Educating surgeons and anesthesiologists on the benefits and administration protocols is critical.
• Operational Logistics: Integrating ZYNRELEF into operative workflows demands training and procedural adjustments.

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3. Pricing and Reimbursement Dynamics

3.1 Pricing Strategies

Initially, ZYNRELEF was positioned at a premium price point (~$300–$400 per kit). The pricing reflects its advanced formulation, clinical benefits, and novel combination. Payers seek demonstrated cost-effectiveness, including reductions in opioid-related complications, length of stay, and readmissions.

3.2 Reimbursement Environment

Reimbursement varies across payers and regions, influenced by coding systems like the CPT and DRG classifications. Positive reimbursement policies depend on clear clinical evidence and health economic models illustrating cost savings.

3.3 Market Access and Adoption

Securing widespread payer coverage fosters broader hospital adoption. Value-based care models, emphasizing patient outcomes and total healthcare costs, serve as motivating factors for formulary inclusion.

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4. Financial Trajectory and Revenue Forecasts

4.1 Revenue Drivers

• Surgical Procedure Volume: Targeted at high-volume procedures such as hernia repairs, orthopedic surgeries, and plastic surgeries.
• Market Penetration Rate: Estimated adoption rates depend on promotional efforts, physician education, and competitive positioning.
• Repeat Usage and Loyalty: Institutional preferences and clinical evidence influence sustained utilization.

4.2 Revenue Projections

Considering current market penetration (~10–15% in approved indications) and surgical procedure numbers, Heron Therapeutics anticipates yearly revenues of $200–$400 million within 3–5 years post-launch (Heron Therapeutics Investor Presentation, 2022). Growth is expected to accelerate with expanded indications, wider geographic reach, and increased clinical adoption.

4.3 Cost Structure and Profitability

• Manufacturing Costs: Economies of scale will reduce per-unit costs as sales volume increases.
• Sales & Marketing Expenses: Substantial investment in physician education, KOL engagement, and market access is crucial.
• Profit Margins: Once established, margins are projected to improve as sales volume surpasses initial marketing investments.

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5. Regulatory and Market Access Risks

5.1 Regulatory Shift Risks

Any regulatory changes affecting approval status, labeling, or safety profiles could impact market confidence and adoption.

5.2 Competition and Innovation Risks

Emerging formulations or novel analgesic modalities may threaten ZYNRELEF’s market share. Continuous innovation and demonstrating robust clinical benefits are essential.

5.3 Reimbursement and Payer Acceptance

Inadequate coverage or delays could slow growth. Demonstrating cost-effectiveness remains key to overcoming reimbursement barriers.

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6. Strategic Opportunities for Growth

6.1 Expanding Indications

Expanding beyond initial surgical procedures, such as orthopedic and plastic surgeries, could significantly increase revenue potential.

6.2 Geographic Expansion

Entering European, Asian, and other international markets offers substantial growth avenues, contingent upon regulatory approvals.

6.3 Formulation and Delivery Enhancements

Developing longer-lasting or more user-friendly formulations could differentiate ZYNRELEF and broaden its clinical utility.

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Key Takeaways

• Market Expansion Driven by Opioid-Sparing Demand: The global push for non-opioid pain management alternatives positions ZYNRELEF favorably within a growing market.

• Competitive Positioning Requires Differentiation: Its unique combination formulation and evidence-backed benefits provide a strategic edge over traditional anesthetics and existing multimodal options.

• Pricing Strategy and Reimbursement Will Influence Adoption: Premium pricing necessitates demonstrating clear value through clinical outcomes and health economics.

• Revenue Trajectory is Promising but Dependent on Market Penetration: Expectations of reaching hundreds of millions in revenue hinge on expanding indications, geographic reach, and provider acceptance.

• Risks and Opportunities co-exist: While regulatory and competitive risks pose challenges, initiatives like indication expansion, clinical education, and cost-effective outcomes can accelerate growth.

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FAQs

1. What differentiates ZYNRELEF from other postoperative analgesics?
ZYNRELEF’s innovative dual mechanism combines bupivacaine with meloxicam, providing extended, opioid-sparing pain relief tailored to surgical infiltration, unlike single-agent local anesthetics or liposomal formulations.

2. Which surgical procedures are most suitable for ZYNRELEF application?
Ideal applications include hernia repairs, orthopedic procedures, and soft tissue surgeries, where controlled, localized, and extended analgesia can improve recovery outcomes.

3. What are the main barriers to market penetration for ZYNRELEF?
Key barriers include high upfront costs, physician familiarity, reimbursement challenges, and competition from established agents like Exparel.

4. How does COVID-19 pandemic impact ZYNRELEF’s commercial prospects?
Elective surgeries declined during the pandemic, temporarily suppressing demand. As elective procedures rebound, demand for advanced analgesic solutions like ZYNRELEF is expected to recover and grow.

5. What is the potential international market for ZYNRELEF?
Global markets with high surgical volumes and evolving pain management protocols present significant opportunities, contingent on successful regulatory approvals and local healthcare policies.

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References

1. Grand View Research. (2022). Postoperative Pain Management Market Size, Share & Trends Analysis.
2. Heron Therapeutics. (2022). Investor Presentation.
3. U.S. Food & Drug Administration. (2021). FDA Approval Letter for ZYNRELEF.

(Note: Additional sources are available upon request and are integral to this comprehensive analysis.)