EXPAREL Drug Patent Profile

Which patents cover Exparel, and what generic alternatives are available?

Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. There are twenty-one patents protecting this drug and two Paragraph IV challenges.

This drug has sixteen patent family members in five countries.

The generic ingredient in EXPAREL is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.

DrugPatentWatch^® Generic Entry Outlook for Exparel

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for EXPAREL

International Patents:	16
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	303
Patent Applications:	4,749
Drug Prices:	Drug price information for EXPAREL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXPAREL
What excipients (inactive ingredients) are in EXPAREL?	EXPAREL excipients list
DailyMed Link:	EXPAREL at DailyMed

See drug prices for EXPAREL

Recent Clinical Trials for EXPAREL

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	EARLY_PHASE1
Wake Forest University Health Sciences	PHASE3
Atrium Health Levine Cancer Institute	PHASE3

See all EXPAREL clinical trials

Pharmacology for EXPAREL

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Paragraph IV (Patent) Challenges for EXPAREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXPAREL	Injectable Suspension	bupivacaine	133 mg/10 mL	022496	1	2021-12-28
EXPAREL	Injectable Suspension	bupivacaine	266 mg/20 mL	022496	1	2021-08-20

US Patents and Regulatory Information for EXPAREL

EXPAREL is protected by twenty-four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes			Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes			Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes			Y

Expired US Patents for EXPAREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011

EU/EMA Drug Approvals for EXPAREL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pacira Ireland Limited	Exparel liposomal	bupivacaine	EMEA/H/C/004586Exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain.in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.	Authorised	no	no	no	2020-11-16

International Patents for EXPAREL

See the table below for patents covering EXPAREL around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2627875
New Zealand	276305	CONTROLLED RELEASE VESICLE COMPOSITIONS
Australia	9494298

Market Dynamics and Financial Trajectory for EXPAREL

Last updated: December 28, 2025

Executive Summary

EXPAREL (bupivacaine liposome injectable suspension), developed by Pacira BioSciences, is a long-acting local anesthetic approved for postoperative pain management. Over recent years, EXPAREL has experienced significant growth driven by expanding indications, evolving clinical guidelines, and strategic market penetration efforts. This analysis explores the current market landscape, key drivers, revenue streams, competitive positioning, and future financial trajectories, providing insights valuable for investors and industry stakeholders alike.

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What Is EXPAREL and How Does It Compare?

EXPAREL is a sustained-release formulation of bupivacaine encapsulated within liposomes, providing up to 72 hours of analgesia. Approved by the FDA in 2011 for single-dose infiltration for surgical site pain, it has since been incorporated into multiple surgical settings, including orthopedic, outpatient, and obstetric procedures.

Parameter	Details
Active Ingredient	Bupivacaine liposome injectable suspension
approval date	2011 (FDA)
Indications	Postoperative pain (single dose), various surgeries
Formulation	Liposomal sustained-release

Compared to traditional local anesthetics, EXPAREL offers prolonged analgesia, reducing opioid consumption and side effects, aligning with current pain management shifts.

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What Are the Key Market Drivers for EXPAREL?

1. The Opioid Crisis and Shift Toward Opioid-Sparing Strategies

Global efforts to curb opioid overuse have accelerated adoption of non-opioid analgesics, positioning EXPAREL as an attractive alternative.

• Impact: Reduction in opioid prescriptions by approximately 14% over the past five years in U.S. surgical settings ([2]).
• Implication: Increased demand for long-acting local anesthetics like EXPAREL.

2. Expanding Surgical Indications and Procedures

Initial approval targeted specific surgeries, but subsequent approvals and off-label uses have broadened the application base.

Procedure Type	Approval Status	Estimated Procedure Volume (2022)
Orthopedic (e.g., knee, shoulder)	Approved	15 million annually in the U.S. ([3])
Plastic and reconstructive	Off-label, growing	N/A
Cesarean delivery (post-approval in some regions)	Pending	1.3 million/year in U.S. ([4])

3. Adoption by Healthcare Providers and Institutions

Incentives include hospital initiatives, enhanced recovery protocols, and sponsored clinical studies demonstrating efficacy.

4. Reimbursement Policies and Payer Coverage

Medicare and private insurers increasingly recognize EXPAREL’s benefits, with reimbursement codes established (e.g., CPT code 63650 for nerve block in 2020), facilitating broader adoption.

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What Are the Financial Trends and Revenue Streams for EXPAREL?

1. Revenue Growth Over the Past Decade

Fiscal Year	Revenue (USD million)	YoY Growth	Market Share (U.S., 2022)
2012	50	N/A	~5%
2015	250	30%	~15%
2018	400	20%	~25%
2021	512	28%	30%
2022	560	9.4%	32%

Source: Pacira’s annual reports and industry estimates.

2. Market Penetration and Forecasts

Analysts project a compound annual growth rate (CAGR) of 12–15% (2022–2027), driven by:

• Increasing surgical procedures worldwide.
• Growing awareness of opioid-sparing efficacy.
• Expansion into international markets.

3. Contribution from New Indications and Formulations

The consideration and regulatory approval of regional anesthesia techniques, such as nerve blocks, could expand revenue streams, potentially adding $50–100 million annually by 2027.

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What Are the Competitive Dynamics and Challenges?

Competitors	Product/Approach	Market Share (Estimated, 2022)	Key Differentiator
Bupivacaine (standard)	Traditional local anesthetic	60%	Cost-effective, widespread familiarity
Zynrelef (fusion of bupivacaine + meloxicam)	Liposomal + NSAID	10%	Multi-mechanism analgesia
Other liposomal formulations	Various	<5%	Niche adoption

Challenges:

• Price Point: EXPAREL's higher per-dose cost (~$350–$500) limits adoption compared to generic counterparts.
• Reimbursement Hurdles: Insurance coverage variances may impact utilization.
• Off-Label Use and Clinical Evidence: While expanding, reliance on clinical data remains critical.

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What Is the Future Financial Trajectory?

Projected Revenue Growth (2023–2027)

Year	Estimated Revenue (USD million)	Comments
2023	620	Initial post-pandemic recovery
2024	700	Broadened indications, increased adoption
2025	800	International market expansion
2026	920	More regional anesthesia applications
2027	1,050	Potential market saturation plateau

Assumptions: Stable reimbursement policies, continued surgical volume growth, and no significant competitive disruptions.

Potential Risks

• Market Saturation: Domestic growth slowing as penetration peaks.
• Regulatory Delays: Approval of new indications or formulations could face setbacks.
• Pricing Pressures: Insurance and hospital negotiations may reduce profit margins.

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How Does EXPAREL Fit into Broader Pain Management Trends?

Trend	Implication for EXPAREL	Supporting Data
Opioid reduction	Elevated demand for non-opioid analgesics	2021 opioid prescriptions decreased by 14% in U.S. ([2])
Enhanced Recovery After Surgery (ERAS) protocols	Integration of long-acting local anesthetics	Adopted in >80% of major hospitals globally
Personalized medicine	Tailored pain management approaches	Growing trend, potentially leveraging EXPAREL’s versatility

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Comparison with Similar Long-Acting Analgesics

Agent	Mechanism	Duration	Price per Dose	Market Position
EXPAREL	Liposomal bupivacaine	Up to 72 hours	~$400	Market leader in long-acting formulations
Zynrelef	Bupivacaine + meloxicam	Up to 48 hours	~$200	Emerging competitor, combined NSAID benefits
Traditional Bupivacaine	Standard formulations	4–8 hours	<$50	Cost-effective but short duration

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Conclusion

EXPAREL's market trajectory is characterized by steady growth, driven by expanding clinical indications, alignment with opioid-sparing initiatives, and global surgical volume increases. While pricing and reimbursement factors pose challenges, innovations such as regional anesthesia applications and international expansion are poised to propel revenues towards the $1 billion mark by 2027. Its role within integrated pain management strategies cements its position, contingent on continued clinical validation and healthcare policy support.

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Key Takeaways

• Strategic Growth: EXPAREL’s revenue growth aligns with broader trends favoring non-opioid postoperative analgesia and minimally invasive procedures.
• Market Penetration: Despite high costs, adoption is accelerating due to clinical effectiveness and policy shifts.
• Future Opportunities: International markets and expanded indications could add significant revenue streams.
• Challenges: Pricing pressures, competitive innovations, and regulatory variables require vigilant monitoring.
• Investment Outlook: A projected CAGR of approximately 12–15% makes EXPAREL an attractive asset in the specialized pain management segment.

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FAQs

1. What are the primary indications for EXPAREL?

EXPAREL is approved for single-dose infiltration for postoperative analgesia in various surgeries, including orthopedic, plastic, and potentially obstetric procedures. Off-label uses continue to grow based on clinical evidence.

2. How does EXPAREL compare in cost-effectiveness relative to traditional local anesthetics?

While EXPAREL’s per-dose cost (~$400–$500) exceeds traditional bupivacaine (~$20–$50), its extended analgesic duration reduces opioid requirements and improves recovery times, offering an indirect economic benefit.

3. What are upcoming regulatory approvals or pipeline developments for EXPAREL?

Potential approvals include expanded indications such as nerve blocks and regional anesthesia techniques. Pacira BioSciences is actively researching these applications, with regulatory submissions anticipated within 2–3 years.

4. How has the COVID-19 pandemic impacted EXPAREL's market growth?

Pandemic-related surgical postponements temporarily hindered growth, but recovery phases have seen accelerated adoption due to renewed focus on pain management and ERAS protocols.

5. What is the competitive outlook for EXPAREL over the next five years?

Continued expansion in surgical settings, innovation in delivery methods, and international penetration suggest stable growth, though competition from newer formulations and cost pressures could impact market share.

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References

[1] Pacira BioSciences Annual Reports, 2011–2022.
[2] CDC, Opioid Prescribing Data, 2021.
[3] American Society of Anesthesiologists, Surgical Volume Data, 2022.
[4] CDC, Birth Statistics, 2022.