Pacira BioSciences Files EXPAREL® Patent Infringement Lawsuits Against The WhiteOak Group and Qilu Pharmaceutical

Rhea-AI Summary

{"summary":"","positive":[],"negative":[],"faq":[]}

News Market Reaction

-1.01%

1 alert

-1.01% News Effect

On the day this news was published, PCRX declined 1.01%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

FDA approval stay: 30-month stay EXPAREL patents: 21 patents Patent family expiry 1: Jan 22, 2041 +1 more

4 metrics

FDA approval stay 30-month stay Stay of final FDA approval of generic ANDAs under Hatch Waxman Act

EXPAREL patents 21 patents Patents listed in FDA Orange Book protecting EXPAREL

Patent family expiry 1 Jan 22, 2041 Expiration date of first EXPAREL patent family

Patent family expiry 2 Jul 2, 2044 Expiration date of second EXPAREL patent family

Market Reality Check

Price: $20.68 Vol: Volume 1,121,293 is 1.68x...

high vol

$20.68 Last Close

Volume Volume 1,121,293 is 1.68x the 20-day average, indicating elevated interest pre-announcement. high

Technical Price $25.73 is trading above the 200-day MA of $24.32 and within 7% of the 52-week high of $27.64.

Peers on Argus

PCRX was up 1.66% while peers were mixed: COLL (-1.23%), DVAX (-0.82%), AMPH (+0...

PCRX was up 1.66% while peers were mixed: COLL (-1.23%), DVAX (-0.82%), AMPH (+0.35%), AVDL (-0.37%), HROW (+1.98%). This pattern points to stock-specific dynamics rather than a broad sector move.

Historical Context

5 past events · Latest: Dec 03 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Inducement grants	Neutral	+0.5%	RSU grants to new employees under inducement equity plan.
Dec 02	Clinical study data	Positive	+1.6%	Pilot study showed better pain and function outcomes with iovera°.
Nov 26	Patent litigation	Positive	-1.0%	Filed EXPAREL patent suits seeking to block generic entrants.
Nov 11	Conference participation	Neutral	+4.5%	Announced fireside chats at two healthcare investor conferences.
Nov 10	Strategic pressure	Positive	+4.5%	Investor letter urging exploration of a potential sale of the business.

Pattern Detected

Recent news has generally seen positive price reactions, with the EXPAREL patent lawsuit being the only noted negative reaction despite protective IP messaging.

Recent Company History

Over the last few months, Pacira reported Q3 results with $179.5M in revenue and net income, insider sales under Rule 10b5-1 plans, and conference participation announcements. Clinical data for iovera° in chronic low back pain showed statistically significant pain and functional improvements. A prior headline on these same EXPAREL patent lawsuits saw a -1.01% move, contrasting with generally positive reactions of up to 4.55% on other corporate developments.

Market Pulse Summary

This announcement detailed patent infringement lawsuits over EXPAREL that triggered a 30‑month stay ...

Analysis

This announcement detailed patent infringement lawsuits over EXPAREL that triggered a 30‑month stay of final FDA approval for the defendants’ ANDAs and cited 21 Orange Book‑listed patents, with expirations extending to 2041 and 2044. In context of recent favorable clinical data and generally positive reactions to past news, investors may watch how these cases progress, any developments in generic challenges, and future updates on Pacira’s broader product portfolio.

Key Terms

hatch waxman act, abbreviated new drug application, u.s. food and drug administration, fda, +3 more

7 terms

hatch waxman act regulatory

"Lawsuit triggers 30-month stay under the Hatch Waxman Act"

A federal law that sets the rules for when cheaper generic versions of prescription drugs can come to market and how long original drug makers can keep exclusive sales. Think of it as the referee that balances allowing lower-cost copies to compete sooner while giving innovators limited extra protection and a clear court process for patent disputes; this timing and legal risk can dramatically affect a drug maker’s revenue and an investor’s valuation.

abbreviated new drug application regulatory

"generic products described in each company’s Abbreviated New Drug Application (ANDA)"

An abbreviated new drug application is a regulatory submission used to gain approval to market a generic version of an already approved prescription medicine by showing it is equivalent in effect and safety to the original product, without repeating full clinical trials. For investors, an approval signals a lower-cost competitor entering the market that can quickly capture sales from the branded drug, similar to a generic knock‑off replacing a name‑brand item on store shelves.

u.s. food and drug administration regulatory

"ANDA filed with the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"ANDA filed with the U.S. Food and Drug Administration (FDA)"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

orange book regulatory

"patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book)"

A publicly maintained FDA database that lists approved prescription drugs and notes which versions are considered interchangeable with brand-name products, along with key patent and exclusivity dates. Think of it as a product roster plus an expiration calendar: investors use it to see when a drug’s protection ends and generic competition can enter, which can directly affect a company’s sales, future revenue and stock value.

bioequivalence medical

"manufacture these specific generic products on a commercial scale, establish bioequivalence"

When two medicines deliver the same amount of active ingredient into the bloodstream at about the same speed and level, they are considered bioequivalent. Investors care because bioequivalence is the regulatory test that allows generic or reformulated drugs to replace branded products without new safety trials, often opening large, lower‑cost market opportunities and changing a drug maker’s sales and competitive position—like two recipes that taste the same but sell at different prices.

injectable suspension medical

"EXPAREL® (bupivacaine liposome injectable suspension)"

An injectable suspension is a medicine made of tiny solid particles evenly spread through a liquid so it can be given by injection; think of sand suspended in water rather than fully dissolved. For investors, this matters because such formulations affect how a drug is manufactured, stored, dosed and regulated—factors that influence production costs, approval hurdles, shelf life and competitive advantage in the marketplace.

AI-generated analysis. Not financial advice.

-- Lawsuit triggers 30-month stay under the Hatch Waxman Act --

BRISBANE, Calif., Nov. 26, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced that it has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against The WhiteOak Group, Inc. and Qilu Pharmaceutical (Hainan) Co., Ltd. for patent infringement related to EXPAREL® (bupivacaine liposome injectable suspension).

The Pacira complaint seeks an injunction to prevent the manufacture, use, and sale of the generic products described in each company’s Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA) prior to the expiration of Pacira’s EXPAREL patents. The lawsuits triggered a 30-month stay of final FDA approval of the ANDAs under the Hatch Waxman Act.

EXPAREL is currently protected by 21 patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). Pacira’s EXPAREL patents are primarily from two distinct patent families and were granted after review by multiple examiners at the U.S. Patent and Trademark Office. The first family has an expiration date of January 22, 2041, and the second has an expiration date of July 2, 2044.

To successfully commercialize a generic version of EXPAREL, The WhiteOak Group and Qilu Pharmaceutical would have to effectively litigate and overcome Pacira’s patents, manufacture these specific generic products on a commercial scale, establish bioequivalence, and secure approval from the FDA.

Pacira has full confidence in the strength of the EXPAREL franchise and its patent portfolio and plans to vigorously defend its intellectual property rights.

About Pacira

Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com.

About EXPAREL® (bupivacaine liposome injectable suspension)

EXPAREL is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older, and postsurgical regional analgesia via an interscalene brachial plexus block in adults, a sciatic nerve block in the popliteal fossa in adults, and an adductor canal block in adults. The safety and effectiveness of EXPAREL have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block, a sciatic nerve block in the popliteal fossa, or an adductor canal block. The product combines bupivacaine with multivesicular liposomes, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the multivesicular liposome platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

Important Safety Information about EXPAREL for Patients

EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old, for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

Forward-Looking Statements

Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: '5x30', our growth and business strategy, our future outlook, the strength and efficacy of our intellectual property protection and patent terms, our future growth potential and future financial and operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act, the expected cost savings and benefits of a July 2025 reduction in force and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and United States economic conditions (including tariffs, inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA, iovera° and any of our other product candidates, including PCRX-201; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company and the anticipated funding or benefits of our share repurchase program. and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Investor Contact:
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com

Media Contact:
Kim Hamilton, (973) 254-4644
kim.hamilton@pacira.com