Pacira BioSciences Notified of Abbreviated New Drug Application Filing from The WhiteOak Group for EXPAREL®
Pacira BioSciences (Nasdaq: PCRX) said it received a Paragraph IV Certification Notice Letter from The WhiteOak Group, which filed an ANDA with the FDA claiming a generic version of EXPAREL.
WhiteOak disputes claims of 19 EXPAREL patents listed in the Orange Book and asserts they are invalid, unenforceable, or not infringed. Pacira identified two patent families with expiration dates of January 22, 2041 and July 2, 2044. Pacira has 45 days from receipt to sue; filing would trigger an automatic 30-month stay of FDA approval under Hatch-Waxman.
Pacira BioSciences (Nasdaq: PCRX) ha comunicato di aver ricevuto una Notifica di Certificazione Paragraph IV da The WhiteOak Group, che ha presentato un ANDA alla FDA affermando una versione generica di EXPAREL.
WhiteOak contesta le pretese di 19 brevetti EXPAREL elencati nel Orange Book e sostiene che siano invalidi, non esperibili o non violati. Pacira ha individuato due famiglie di brevetti con date di scadenza 22 gennaio 2041 e 2 luglio 2044. Pacira ha 45 giorni dalla ricezione per intentare causa; una causa comporterebbe automaticamente una sospensione di 30 mesi dell'approvazione FDA ai sensi di Hatch-Waxman.
Pacira BioSciences (Nasdaq: PCRX) dijo haber recibido una Carta de Notificación de Certificación Paragraph IV de The WhiteOak Group, que presentó un ANDA ante la FDA alegando una versión genérica de EXPAREL.
WhiteOak disputa las afirmaciones de 19 patentes de EXPAREL listadas en el Orange Book y sostiene que son inválidas, no ejecutables o no infringidas. Pacira identificó dos familias de patentes con fechas de vencimiento 22 de enero de 2041 y 2 de julio de 2044. Pacira tiene 45 días desde la recepción para demandar; presentar la demanda activaría automáticamente una suspensión de 30 meses de la aprobación de la FDA conforme a Hatch-Waxman.
Pacira BioSciences (나스닥: PCRX)가 The WhiteOak Group으로부터 Paragraph IV 인증 통지서를 수령했다고 발표했으며, WhiteOak Group은 EXPAREL의 제네릭 버전을 주장하며 FDA에 ANDA를 제출했습니다.
WhiteOak은 Orange Book에 기재된 19개의 EXPAREL 특허의 주장을 다투고 특허가 무효이거나 실행 불가능하거나 침해하지 않는다고 주장합니다. Pacira는 만료일이 2041년 1월 22일과 2044년 7월 2일인 두 특허 계를 확인했습니다. Pacira는 접수 후 45일 이내에 소송을 제기해야 하며, 제소 시 Hatch-Waxman에 따라 FDA 승인에 대한 자동 30개월 정지가 발동됩니다.
Pacira BioSciences (NYSE: PCRX) a déclaré avoir reçu une lettre de notification de Certification Paragraph IV de The WhiteOak Group, qui a déposé un ANDA auprès de la FDA revendiquant une version générique de EXPAREL.
WhiteOak conteste les revendications de 19 brevets EXPAREL répertoriés dans le Orange Book et soutient qu'ils sont invalides, inexécutables ou non violés. Pacira a identifié deux familles de brevets dont les dates d'expiration sont 22 janvier 2041 et 2 juillet 2044. Pacira dispose de 45 jours à partir de la réception pour engager des poursuites; le dépôt déclencherait automatiquement une suspension de 30 mois de l'approbation FDA en vertu de Hatch-Waxman.
Pacira BioSciences (Nasen: PCRX) gab bekannt, dass es ein Paragraph IV-Zertifizierungsbenachrichtigungsschreiben von The WhiteOak Group erhalten hat, die ein ANDA bei der FDA eingereicht hat und eine generische Version von EXPAREL beansprucht.
WhiteOak bestreitet die Ansprüche von 19 EXPAREL-Patenten, die im Orange Book aufgeführt sind, und behauptet, dass sie ungültig, nicht durchsetzbar oder nicht verletzt seien. Pacira identifizierte zwei Patentfamilien mit Ablaufdaten von 22. Januar 2041 und 2. Juli 2044. Pacira hat 45 Tage ab Erhalt, um Klage zu erheben; eine Einreichung würde automatisch eine 30-monatige Aussetzung der FDA-Zulassung gemäß Hatch-Waxman auslösen.
Pacira BioSciences (نازداك: PCRX) قالت إنها تلقت رسالة إشعار شهادة Paragraph IV من The WhiteOak Group، التي قدمت ANDA لدى إدارة الغذاء والدواء الأمريكية Zclaiming نسخة جنيريك من EXPAREL.
WhiteOak يجادل بادعاءات 19 براءة EXPAREL المدرجة في Orange Book ويؤكد أنها غير صالحة أو غير قابلة للتنفيذ أو غير منتهكة. حددت Pacira عائلتين من البراءات بتاريخ انتهاء 22 يناير 2041 و2 يوليو 2044. لدى Pacira 45 يوماً من تاريخ الاستلام للدعوى؛ سيؤدي التقديم إلى تلقائياً تعطيل لمدة 30 شهراً لإقرار FDA بموجب Hatch-Waxman.
Pacira BioSciences (纳斯达克股票代码: PCRX) 表示收到白橡集团的 Paragraph IV 认证通知函，该集团已向 FDA 提交了一个 ANDA，声称 EXPAREL 的仿制版本。
WhiteOak 对在橙皮书中列出的 19 项 EXPAREL 专利的主张提出异议，认为它们无效、不可执行或未侵权。Pacira 确认了两个专利族的到期日，分别为 2041 年 1 月 22 日 和 2044 年 7 月 2 日。Pacira 在收到之日起有 45 天 的时间提起诉讼；提起诉讼将根据 Hatch-Waxman 自动触发 FDA 批准的 30 个月中止。
- Orange Book patents cover EXPAREL with family expirations on Jan 22, 2041
- Second patent family expires on Jul 2, 2044
- Patent litigation would trigger a regulatory 30-month stay of ANDA approval
- WhiteOak filed an ANDA challenging 19 patents listed for EXPAREL
- WhiteOak alleges patents are invalid or unenforceable, creating legal risk
- Receipt of a PIV Notice creates near-term litigation and regulatory uncertainty
BRISBANE, Calif., Oct. 21, 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 reported it has received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of a small private Chinese company. WhiteOak has filed an Abbreviated New Drug Application, or ANDA, with the FDA for a product claiming to be a generic of EXPAREL. Neither WhiteOak nor its parent company have any commercialized products. The parent company is Zhejiang Haichang Biotechnology Co Ltd.
In the PIV Notice, WhiteOak alleges that the claims of 19 EXPAREL patents listed in the FDA’s Orange Book (U.S. Patent Nos.11,033,495, 11,179,336, 11,278,494, 11,304,904, 11,311,486, 11,357,727, 11,426,348, 11,452,691, 11,819,574, 11,819,575, 11,925,706, 12,144,890, 12,151,024, 12,156,940, 12,226,610, 12,251,468, 12,296,047, 12,318,483, 12,370,142) are invalid, unenforceable and/or will not be infringed by WhiteOak’s manufacture, use or sale of the product described in its ANDA submission.
The company’s contested Orange Book listed patents are primarily from two distinct patent families with the first family expiring on January 22, 2041, and the second family expiring on July 2, 2044.
Pacira intends to vigorously assert and enforce its intellectual property rights and has 45 days from receipt of the PIV Notice to file a lawsuit if it deems the ANDA filer is infringing its intellectual property. The lawsuit will trigger an automatic 30-month stay of FDA approval of White Oak’s ANDA submission pursuant to the Hatch Waxman statute.
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: Sara Marino, (973) 370-5430 sara.marino@pacira.com |
FAQ
What did Pacira (PCRX) announce on October 21, 2025 about EXPAREL?
How many EXPAREL patents did WhiteOak challenge in the ANDA against PCRX?
When do Pacira’s contested EXPAREL patent families expire for PCRX investors?
What deadline does Pacira have to respond to the Paragraph IV Notice received by PCRX?
What happens if Pacira sues WhiteOak after the PCRX PIV Notice?
Does WhiteOak have prior commercial products when filing the ANDA against PCRX?
