POSIMIR Drug Patent Profile

When do Posimir patents expire, and what generic alternatives are available?

Posimir is a drug marketed by Innocoll and is included in one NDA. There are six patents protecting this drug.

This drug has sixty-one patent family members in twenty-nine countries.

The generic ingredient in POSIMIR 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 Posimir

Indicators of Generic Entry

Summary for POSIMIR

International Patents:	61
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	125
Patent Applications:	4,469
What excipients (inactive ingredients) are in POSIMIR?	POSIMIR excipients list
DailyMed Link:	POSIMIR at DailyMed

US Patents and Regulatory Information for POSIMIR

POSIMIR is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		DISCN	Yes	No			Y
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		DISCN	Yes	No
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		DISCN	Yes	No			Y

Expired US Patents for POSIMIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021

EU/EMA Drug Approvals for POSIMIR

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 POSIMIR

When does loss-of-exclusivity occur for POSIMIR?

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

Brazil

Canada

China

European Patent Office

Japan

South Korea

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 POSIMIR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2008513467
Japan	2023515918
Canada	2581287	SYSTEME DE DISTRIBUTION COMMANDEE (SUSTAINED LOCAL ANESTHETIC COMPOSITION CONTAINING PREFERABLYA SUGAR ESTER SUCH AS SAIB)

Market Dynamics and Financial Trajectory for POSIMIR

Last updated: July 27, 2025

Introduction

POSIMIR (bupivacaine extended-release submicron particle suspension) emerges as a notable entrant in the local anesthesia market, particularly targeting postoperative pain management. As a product developed by Scilex Pharmaceuticals, POSIMIR is designed as a distinctive sustained-release formulation that delivers prolonged analgesia, reducing the need for systemic opioids and improving patient comfort. Understanding the evolving market dynamics and financial trajectory of POSIMIR requires an assessment of regulatory developments, competitive landscape, market acceptance, and broader healthcare trends influencing local anesthetic therapies.

Regulatory and Commercial Milestones

The U.S. Food and Drug Administration (FDA) approved POSIMIR in July 2018 for infiltration anesthesia in soft tissue and surgical wounds. The approval was supported by clinical data indicating sustained analgesia over 72 hours and a favorable safety profile. However, subsequent years have been characterized by limited commercialization success, attributed partly to regulatory hurdles, manufacturing challenges, and market hesitations concerning adoption.

In 2020, Scilex Pharmaceuticals announced plans to reposition POSIMIR, emphasizing strategic commercialization efforts and exploring broader indications, including potential use in outpatient and ambulatory surgery settings. Despite these ambitions, the product's market penetration has remained limited relative to competitors, with sales figures trailing initial projections.

Market Landscape and Competitive Forces

Postoperative Pain Management Market

The global postoperative pain management market was valued at approximately USD 10 billion in 2021 and projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2028, driven by rising surgical procedures, aging populations, and a shift towards outpatient surgeries. Key players include conventional local anesthetics like lidocaine and bupivacaine, as well as advanced formulations such as liposomal bupivacaine (EXPAREL), which competes directly with POSIMIR due to its sustained-release profile.

Competitive Positioning of POSIMIR

While POSIMIR offers extended analgesia with a potentially favorable safety profile, it faces substantial competition from established products like EXPAREL, marketed by Pacira Biosciences, which boasts robust clinical data, wide provider acceptance, and an entrenched market presence. The cost differential and formulary positioning further impact POSIMIR’s market adoption. Moreover, healthcare providers' familiarity with existing modalities and constraints on new product uptake pose barriers to POSIMIR's growth.

Reimbursement and Pricing Dynamics

Reimbursement policies significantly influence market performance. POSIMIR's pricing strategy must balance profitability with competitive penetration, especially as insurers scrutinize costs amidst burgeoning anesthesia options. Limited coverage or prior authorization requirements can impede widespread utilization, constraining revenue generation.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Since its approval, POSIMIR's fiscal reports indicate modest sales, with revenues largely operating in the low millions of dollars annually. For instance, Scilex’s 2021 annual report notes sales in the ‘low single digits’ million USD range, reflecting limited adoption and ongoing commercialization challenges. The product’s revenue trajectory has been constrained by:

• Insufficient clinical awareness among surgeons and anesthesiologists.
• Delays in obtaining expanded indications.
• Competition from more established, reimbursable options.

Forecasting Future Revenue

Projections suggest that unless significant market acceptance occurs, POSIMIR's revenues will remain subdued in the near term. Targeted efforts to expand indications, improve formulary inclusion, and increase provider education could catalyze growth. Nevertheless, reaching a breakthrough comparable to competitors like EXPAREL may require considerable marketing investment or partnership strategies.

Assuming the implementation of effective commercialization strategies, a conservative CAGR of 10-15% over the next five years could be envisioned, contingent upon market expansion, clinical trial success, and reimbursement improvements. However, given current market saturation and incumbent dominance, early years are expected to show limited growth unless significant strategic pivots are made.

Potential Revenue Scenarios

• Optimistic Scenario: With successful indication expansion and increased physician adoption, revenues could approach USD 50-100 million annually within five years, primarily driven by outpatient procedures and hospitals seeking opioid-sparing solutions.
• Pessimistic Scenario: Without meaningful market penetration, POSIMIR may sustain revenues below USD 10 million annually, risking limited profitability and potential reevaluation of resource allocation.

Influence of Broader Healthcare Trends

The industry’s pivot towards opioid reduction and enhanced recovery protocols positions products like POSIMIR favorably, assuming clinical efficacy and cost-effectiveness are demonstrated convincingly. The opioid epidemic has created a regulatory and cultural climate favoring non-opioid analgesics, potentially benefiting sustained-release local anesthetics.

Additionally, the surge in outpatient and ambulatory surgeries offers a growth vector for POSIMIR, provided the product's logistical and cost advantages align with clinical workflows.

Strategic Challenges and Opportunities

Challenges

• Entrenched competitor products with established reimbursement and clinician familiarity.
• Limited clinical data beyond initial trials, necessitating further real-world evidence.
• Commercialization barriers involving manufacturing scalability and supply chain considerations.
• Cost and formulary debates affecting provider adoption.

Opportunities

• Expanding indications into dental surgery, dermatology, and outpatient procedures.
• Demonstrating cost savings through reduced hospital stay and opioid use.
• Strategic partnerships with healthcare systems to foster product integration.
• Leveraging digital health tools for physician education and remote prescribing facilitation.

Key Takeaways

• POSIMIR, with its sustained-release profile, aligns with industry trends emphasizing opioid-sparing postoperative pain management but faces stiff competition from established therapies.
• Market penetration remains limited, with revenue trajectories dependent on increased provider adoption, broader indications, and favorable reimbursement policies.
• Near-term growth prospects are cautious without strategic improvements in commercialization, clinical evidence, and market education. Contingent success could see revenues scaling up significantly within five years.
• The broader shift towards outpatient surgeries and opioid reduction policies offer growth catalysts if POSIMIR can demonstrate clear clinical and economic advantages.
• Strategic focus on expanding indications, accumulating real-world data, and establishing preferential formulary status will be critical to unlocking POSIMIR’s financial potential.

Conclusion

The financial trajectory of POSIMIR is currently characterized by constrained growth amid stiff competition and commercialization hurdles. However, the shifting healthcare landscape favoring non-opioid, sustained-release local anesthetics presents a potential upside if strategic and clinical milestones are achieved. Long-term success hinges on market acceptance, reimbursement landscape evolution, and the manufacturer's ability to differentiate POSIMIR as a cost-effective, clinically superior solution in postoperative pain management.

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FAQs

1. What are the main advantages of POSIMIR over traditional local anesthetics?
   POSIMIR provides extended analgesia over 72 hours with a single infiltration, potentially reducing opioid use and improving post-surgical pain control.

2. Why has POSIMIR struggled with market adoption?
   Challenges include competition from established products like EXPAREL, limited clinical awareness, reimbursement hurdles, and manufacturing or clinical trial delays.

3. What is the potential market size for POSIMIR?
   The global postoperative pain management market exceeds USD 10 billion, with outpatient surgery growth offering incremental opportunities for sustained-release products like POSIMIR.

4. How does reimbursement impact POSIMIR's financial prospects?
   Favorable reimbursement policies facilitate high adoption; however, high costs or restrictive insurer policies could limit sales potential.

5. Can POSIMIR expand into other indications?
   Yes, expanding into dental, dermatological, or outpatient surgical procedures offers growth avenues, provided clinical trials support such uses.

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Sources

1. [1] Scilex Pharmaceuticals, 2022 Annual Report.
2. [2] MarketWatch, Postoperative Pain Management Market Size, 2022.
3. [3] FDA Approval Document for POSIMIR, 2018.
4. [4] Pacira Biosciences, EXPAREL Market Overview.
5. [5] Healthcare Provider Surveys, 2022.