Pacira BioSciences Resolves Patent Issues for EXPAREL

Pacira BioSciences Settles Patent Litigation for EXPAREL

Pacira BioSciences, Inc. (NASDAQ: PCRX), a leader in innovative pain management, has made significant strides in the ongoing development of its flagship product, EXPAREL. The company's recent settlement with Fresenius Kabi USA, LLC, marks a critical juncture in the market for bupivacaine liposome injectable suspension. This resolution brings clarity and hope to patients seeking effective, non-opioid alternatives for pain management.

The Agreement Details

Under the terms of the settlement, Fresenius Kabi is now licensed to sell a limited volume of generic bupivacaine liposome injectable suspension starting in a confidential timeframe set for 2030. This agreement ensures that patients will begin to have access to these vital treatments while recognizing Pacira's intellectual property rights. The pricing and distribution details surrounding these volumes remain confidential, but they are projected to grow significantly over the coming years.

Long-Term Market Entry

This settlement also provides a strategic framework for Fresenius to sell an unrestricted volume of this medication beginning in 2039, allowing for a broader market impact. Essentially, it opens doors for Fresenius while still protecting Pacira’s patent rights until the eventual expiration date in 2044. This method of gradual market entry recognizes the investment Pacira has made in developing its product.

Statements from Leadership

“This settlement is a testament to the strength of our EXPAREL intellectual property portfolio,” stated Frank D. Lee, the CEO of Pacira. With the resolution of litigation, the company can shift its focus towards expanding its innovative approaches to pain management. Pacira’s commitment to developing solutions that address acute and chronic pain is paramount, especially considering the millions of Americans living with ongoing pain conditions.

Focus on Patient Care

Pacira is dedicated to improving patients' lives through non-opioid therapies. Their commercial portfolio includes three significant products: EXPAREL, ZILRETTA, and iovera°. EXPAREL, specifically, is approved for various postsurgical pain management procedures, allowing for targeted pain relief without the need for opioid medications.

Innovative Technology Development

Moreover, Pacira is working on advancing PCRX-201, a groundbreaking gene therapy designed to address widespread conditions such as osteoarthritis. This initiative reflects Pacira’s forward-thinking strategy to address unmet medical needs through innovative technologies. The company’s unwavering commitment to patients is evident in every aspect of its ongoing development and strategic planning.

Frequently Asked Questions

What is the significance of the settlement for Pacira BioSciences?

The settlement allows Fresenius to introduce a generic version of EXPAREL under strict volume limitations, ensuring patient access while still upholding Pacira's patent rights.

When can Fresenius start selling their generic version of EXPAREL?

Fresenius can start selling a volume-limited version of generic bupivacaine liposome injectable suspension in early 2030, expanding to unlimited access by 2039.

What does this mean for patients needing pain management?

This agreement paves the way for more options in non-opioid pain management, potentially lowering costs and improving accessibility for patients.

How does this settlement affect Pacira's business strategy?

With litigation resolved, Pacira can focus on its 5x30 strategy that aims to enhance its offerings in musculoskeletal pain and address broader pain management needs.

Why is Pacira's commitment to non-opioid treatments important?

Pacira’s focus on non-opioid therapies is crucial in combatting the opioid crisis, providing safer alternatives for pain management without the associated risks of addiction.

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