Pacira Awarded New U.S. Patent Covering EXPAREL Composition
Pacira BioSciences (Nasdaq: PCRX) has been awarded U.S. Patent No. 12,156,940 for EXPAREL's chemical composition, providing protection until July 2044. This patent is the first in a new family related to EXPAREL produced by their enhanced manufacturing process in San Diego, approved by FDA in February 2024. The company plans to list the patent in the FDA Orange Book and file a patent infringement lawsuit against Jiangsu Hengrui Pharmaceuticals and Fresenius Kabi USA. Additionally, two new patents (No. 12,151,024 and 12,144,890) were issued, extending protection until January 2041.
Pacira BioSciences (Nasdaq: PCRX) ha ricevuto il brevetto statunitense n. 12,156,940 per la composizione chimica di EXPAREL, che garantirà protezione fino a luglio 2044. Questo brevetto è il primo di una nuova famiglia relativa a EXPAREL, prodotto grazie al loro processo di produzione avanzato a San Diego, approvato dalla FDA nel febbraio 2024. L'azienda prevede di inserire il brevetto nel FDA Orange Book e di intentare una causa per violazione di brevetto contro Jiangsu Hengrui Pharmaceuticals e Fresenius Kabi USA. Inoltre, sono stati concessi due nuovi brevetti (n. 12,151,024 e 12,144,890), che estendono la protezione fino a gennaio 2041.
Pacira BioSciences (Nasdaq: PCRX) ha recibido la patente estadounidense No. 12,156,940 para la composición química de EXPAREL, proporcionando protección hasta julio de 2044. Esta patente es la primera de una nueva familia relacionada con EXPAREL, producido por su avanzado proceso de fabricación en San Diego, aprobado por la FDA en febrero de 2024. La empresa planea listar la patente en el Libro Naranja de la FDA y presentar una demanda por infracción de patente contra Jiangsu Hengrui Pharmaceuticals y Fresenius Kabi USA. Además, se emitieron dos nuevas patentes (número 12,151,024 y 12,144,890), ampliando la protección hasta enero de 2041.
Pacira BioSciences (Nasdaq: PCRX)는 EXPAREL의 화학 조성에 대한 미국 특허 제12,156,940호를 부여받았으며, 이는 2044년 7월까지 보호됩니다. 이 특허는 샌디에고에서의 향상된 제조 공정으로 생산된 EXPAREL과 관련된 새로운 특허 군의 첫 번째입니다. 이 공정은 2024년 2월 FDA의 승인을 받았습니다. 회사는 이 특허를 FDA 오렌지 북에 등록하고 Jiangsu Hengrui Pharmaceuticals 및 Fresenius Kabi USA를 상대로 특허 침해 소송을 제기할 계획입니다. 또한 두 개의 새로운 특허(제12,151,024호 및 제12,144,890호)가 발급되어 2041년 1월까지 보호 범위가 연장되었습니다.
Pacira BioSciences (Nasdaq: PCRX) a été décerné le brevet américain n° 12,156,940 pour la composition chimique d'EXPAREL, offrant une protection jusqu'en juillet 2044. Ce brevet est le premier d'une nouvelle famille liée à EXPAREL produit par leur processus de fabrication amélioré à San Diego, approuvé par la FDA en février 2024. L'entreprise prévoit d'inscrire le brevet dans le Livre Orange de la FDA et d'intenter une action en contrefaçon de brevet contre Jiangsu Hengrui Pharmaceuticals et Fresenius Kabi USA. De plus, deux nouveaux brevets (n° 12,151,024 et n° 12,144,890) ont été délivrés, prolongeant la protection jusqu'en janvier 2041.
Pacira BioSciences (Nasdaq: PCRX) hat das US-Patent Nr. 12,156,940 für die chemische Zusammensetzung von EXPAREL erhalten, das bis Juli 2044 Schutz bietet. Dieses Patent ist das erste einer neuen Familie, die sich auf EXPAREL bezieht, das durch ihren verbesserten Herstellungsprozess in San Diego produziert wird, der im Februar 2024 von der FDA genehmigt wurde. Das Unternehmen plant, das Patent im FDA Orange Book aufzulisten und eine Klage wegen Patentverletzung gegen Jiangsu Hengrui Pharmaceuticals und Fresenius Kabi USA einzureichen. Darüber hinaus wurden zwei neue Patente (Nr. 12,151,024 und 12,144,890) erteilt, die den Schutz bis Januar 2041 verlängern.
- New patent protection for EXPAREL extends until 2044
- Additional patents (No. 12,151,024 and 12,144,890) provide protection until 2041
- Enhanced large-scale manufacturing process received FDA approval
- Ongoing patent litigation against competitors
- Company's U.S. Patent No. 11,033,495 was found invalid by New Jersey Court
Insights
The issuance of Patent No. 12,156,940 represents a significant strategic win for Pacira, extending EXPAREL's intellectual property protection until 2044. This patent specifically covers the chemical composition of their flagship product and manufacturing process, creating a substantial barrier for generic competitors. The company's aggressive patent strategy includes multiple layers of protection:
- New manufacturing process patent family initiated
- Orange Book listing eligibility strengthens market position
- Active litigation against potential competitors Jiangsu Hengrui and eVenus
- Additional patents ('024 and '890) further fortify protection until 2041
The comprehensive IP strategy and ongoing litigation demonstrate strong determination to maintain market exclusivity. However, the pending appellate review of the '495 patent validity creates some uncertainty in the overall patent portfolio strength.
-- First in new family of EXPAREL patents --
-- Expands EXPAREL intellectual property and provides protection into 2044 --
PARSIPPANY, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies, today announced the receipt of U.S. Patent No. 12,156,940 (the ‘940 patent) from the U.S. Patent and Trademark Office (the U.S. PTO). The ‘940 patent, entitled “Manufacturing of Bupivacaine Multivesicular Liposomes” protects the chemical composition of EXPAREL® (bupivacaine liposome injectable suspension). This patent is the first patent from a new family of patents related to EXPAREL produced by the company’s enhanced large-scale manufacturing process in San Diego, which received approval from the U.S. Food and Drug Administration in February 2024. The company expects the ‘940 patent to provide protection into July 2044.
“This new patent highlights our commitment to building a broad portfolio of intellectual property to protect our EXPAREL franchise by expanding its patent life into 2044,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “This patent, the first of a new family of patents, underscores Pacira’s deep manufacturing expertise and the team’s commitment to innovation. We firmly believe we have a strong portfolio of intellectual property and the EXPAREL franchise is well protected on multiple levels.”
Pacira will submit the ‘940 patent for listing in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). Patents that are eligible for Orange Book listing are those that have claims covering the active ingredient, the drug product (formulation and composition) or the approved method of use. The company continues to prosecute patent applications and anticipates additional patents are forthcoming.
Commitment to Protecting EXPAREL Franchise
With the issuance of the ‘940 patent, the company intends to file a patent infringement lawsuit against Jiangsu Hengrui Pharmaceuticals Co. LTD., and its U.S. distributor, Fresenius Kabi USA, LLC.
A separate lawsuit is advancing against eVenus Pharmaceutical Laboratories, Inc., its China-based parent company, Jiangsu Hengrui, and Fresenius for infringement of U.S. Patent No. 11,819,574 (the ‘574 patent) in the U.S. District Court for the District of New Jersey. Pacira is also pursuing an appellate review at the Federal Circuit for the New Jersey Court’s finding that the company’s U.S. Patent No. 11,033,495 (the ‘495 patent) is not valid. To be successful commercially, eVenus, Jiangsu Hengrui, and Fresenius will have to overcome each of Pacira’s patents.
Expansion of Erucic Acid Family of Patents
The U.S. PTO recently issued U.S. Patent Nos. 12,151,024 (the ‘024 patent) and 12,144,890 (the ‘890 patent). The ‘024 and ‘890 patents belong to the ‘574 and ‘495 family of patents and are listed in the Orange Book with an expiration date of January 21, 2041.
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 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 ioveraº®, 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, 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.
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 our future outlook, our intellectual property and patent terms, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act and 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 those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the integration of our new chief executive officer; risks associated with acquisitions, such as the risk that the acquired 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 U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow 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 and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. 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 ability to successfully integrate any future acquisitions into our existing business; 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; 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 (the “SEC”). 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.
FAQ
When does Pacira's new EXPAREL patent (No. 12,156,940) expire?
What companies is PCRX filing patent infringement lawsuits against?
When was PCRX's enhanced manufacturing process in San Diego approved by FDA?
