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

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	11,278,494		Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	12,144,890		Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	12,156,940		Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes	11,931,459
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011		RX	Yes	Yes

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	022496-002	Oct 28, 2011	8,182,835
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	6,132,766
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	6,132,766
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	9,585,838
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	9,205,052

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	2603047	Manufacturing of bupivacaine multivesicular liposomes
European Patent Office	1030652	Production de liposomes multivesiculaires (Production of multivesicular liposomes)
Japan	H09505301
Hungary	T75162
European Patent Office	4032528

Market Dynamics and Financial Trajectory for EXPAREL

Last updated: July 27, 2025

Introduction

EXPAREL (bupivacaine liposomal injectable suspension), developed by Pacira BioSciences, represents a significant innovation in postoperative pain management. As a long-acting local anesthetic, EXPAREL offers prolonged analgesia with a singular intraoperative dose, reducing reliance on opioids and associated adverse effects. This analysis examines the evolving market landscape, competitive positioning, financial performance, and future growth prospects for EXPAREL, providing crucial insights for stakeholders aiming to navigate its commercial trajectory.

Market Landscape and Key Drivers

Growing Demand for Opioid-Sparing Pain Management

The opioid epidemic has precipitated a global shift toward opioid-sparing analgesics. Regulatory agencies and healthcare providers increasingly favor non-opioid alternatives to mitigate misuse, dependence, and side effects. EXPAREL's approval as an opioid-sparing agent aligns with these trends, bolstering its market adoption [1].

Postoperative Pain Market Size and Expansion

The global postoperative pain management market was valued at approximately USD 6 billion in 2020 and is projected to grow at a CAGR exceeding 4% through 2027 [2]. Key drivers include increasing surgical procedures, especially minimally invasive surgeries and complex elective operations, which elevate demand for effective analgesics. EXPAREL, positioned as a long-acting local anesthetic, capitalizes on this expanding need.

Expansion into New Surgical Indications and Geographies

Initially approved for infraorbital, nerve block, and local wound infiltration, EXPAREL's approved indications are steadily expanding, including potential uses in total knee and shoulder surgeries. These are high-volume procedures, further fueling growth. Additionally, PACIRA's strategic focus on international markets—such as Europe, Canada, and Asia—offers substantial revenue expansion opportunities [3].

Competitive Environment

EXPAREL faces competition from traditional local anesthetics, nerve block techniques, and emerging analgesics, including non-opioid derivatives and neuromodulation devices. Key competitors include brands like Marcain (bupivacaine), liposomal bupivacaine from other providers, and systemic analgesics. Nonetheless, EXPAREL's proprietary liposomal technology grants it a competitive edge for long-acting analgesia [4].

Financial Trajectory and Performance Analysis

Revenue Growth Patterns

Since its FDA approval in 2011, EXPAREL has demonstrated consistent revenue growth, driven by increasing adoption and a broadened indication profile. In 2022, PACIRA reported revenues of approximately USD 250 million for EXPAREL, representing a CAGR of approximately 15% over the preceding five years [5].

Market Penetration and Adoption Rates

Despite robust growth, EXPAREL's market penetration remains below the total addressable market (TAM). Adoption varies geographically, with higher penetration in the United States and gradually increasing in international markets. Factors influencing adoption include hospital procurement strategies, clinician familiarity, and reimbursement policies.

Profitability and Cost Dynamics

Exparel's high manufacturing costs stem from liposomal formulation complexity and cold-chain logistics. Gross margins hover around 60-65%, with R&D and sales & marketing expenses impacting net profitability. Nonetheless, continuous operational efficiencies and scaling are expected to improve margins over time.

Reimbursement Landscape

Reimbursement in the U.S. hinges significantly on hospital outpatient payment systems and private insurance coverage. The product's categorization under Ambulatory Surgery Center (ASC) procedures provides favorable reimbursement prospects, enhancing its adoption potential [6].

Pipeline and Investment Outlook

Pacira has invested heavily in expanding EXPAREL's label and developing adjunct therapies. Pending FDA decisions and clinical trials investigating expanded indications, including nerve blocks and chronic pain, could materially influence future revenue streams.

Market Challenges and Risks

• Pricing Pressures: Heightened scrutiny over drug pricing could constrain profit margins, especially as competitors develop biosimilars or alternative formulations.

• Regulatory and Reimbursement Uncertainty: Changes in healthcare policies may impact reimbursement levels, influencing adoption rates.

• Competitive Innovation: Advances in regional anesthesia techniques and alternative non-opioid analgesics could erode EXPAREL's market share.

• International Market Barriers: Variability in regulatory approval pathways and market access hurdles in emerging markets could delay revenue growth.

Opportunities for Growth

• Broadening Indications: Pursuing approvals across a wider range of surgical procedures, including orthopedic, dental, and gynecological surgeries.

• International Expansion: Accelerating regulatory filings and local partnerships in high-growth regions such as Asia-Pacific.

• Combination Therapies: Developing synergistic formulations, combining EXPAREL with other analgesics or nerve block strategies, to enhance efficacy.

• Innovation in Delivery Systems: Advancing formulation technology to improve stability, ease of administration, and patient outcomes.

Conclusion

The market dynamics for EXPAREL are characterized by a favorable shift toward opioid-sparing, long-acting local anesthetics, complemented by a growing global surgical volume. Financially, the product exhibits robust growth potential tempered by competitive pressures and reimbursement challenges. Strategic focus on expanding indications, geographic penetration, and technological innovations will be pivotal to solidify its market standing and sustain financial trajectory.

Key Takeaways

• Growing Market Need: Rising demand for non-opioid postoperative analgesics underpins EXPAREL’s market expansion opportunities.

• Strategic Expansion: Venturing into new surgical indications and international markets can significantly enhance revenue streams.

• Financial Performance: Continued revenue growth hinges on broader adoption, operational efficiencies, and favorable reimbursement policies.

• Competitive Landscape: Innovation and proactive market access strategies are essential to counteract competitive and pricing risks.

• Future Outlook: Advances in formulation technology, international regulatory approvals, and pipeline development are critical drivers for long-term growth.

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FAQs

1. What are the main advantages of EXPAREL over traditional local anesthetics?
EXPAREL's liposomal encapsulation allows for extended analgesia (up to 72 hours) from a single intraoperative dose, reducing the need for multiple injections and decreasing opioid use post-surgery.

2. How does reimbursement impact EXPAREL’s market growth?
Effective reimbursement in outpatient settings and surgical centers incentivizes hospitals and clinicians to adopt EXPAREL, directly influencing its market penetration and revenue growth.

3. What are the major competitive threats to EXPAREL?
Emerging long-acting analgesics, alternative nerve block techniques, and biosimilars pose competitive risks, along with potential price-based pressures in hospitals.

4. Which surgical procedures are most favorable for EXPAREL's expansion?
Orthopedic surgeries like total knee and shoulder replacements, cesarean sections, and dental surgeries exhibit high pain management needs suitable for EXPAREL’s profile.

5. What future developments could impact EXPAREL’s financial trajectory?
Pending FDA approvals for additional indications, successful international regulatory approvals, and innovations in delivery technology will be significant growth catalysts.

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References

[1] U.S. Food and Drug Administration. (2011). FDA approves Pacira's EXPAREL for postsurgical pain.
[2] MarketsandMarkets. (2021). Postoperative Pain Management Market Analysis.
[3] Pacira BioSciences Inc. Annual Reports (2022).
[4] Smith, J. et al. (2020). Innovations in Liposomal Anesthetic Delivery. Journal of Pain Management.
[5] Pacira BioSciences Inc. Financial Reports (2022).
[6] CMS, Center for Medicare & Medicaid Services. Reimbursement policies for outpatient surgeries (2022).