Pacira BioSciences Announces Settlement of U.S. Patent Litigation for EXPAREL
Pacira BioSciences (NASDAQ: PCRX) has announced a settlement of patent litigation with Fresenius Kabi USA and other companies regarding EXPAREL® (bupivacaine liposome injectable suspension). The settlement grants Fresenius two key licenses:
1. A volume- license starting in early 2030, beginning with high-single-digit percentage of U.S. market volumes, gradually increasing to the high thirties percentage by the final three years.
2. An unlimited volume license beginning no earlier than 2039.
The agreement comes before the July 2, 2044 expiration of Pacira's last Orange Book-listed EXPAREL patent. The settlement resolves all outstanding claims and includes Consent Judgments filing with various U.S. Courts to prevent Fresenius from marketing generic versions before the agreed terms.
Pacira BioSciences (NASDAQ: PCRX) ha annunciato un accordo per la risoluzione di contenziosi sui brevetti con Fresenius Kabi USA e altre aziende riguardanti EXPAREL® (sospensione iniettabile di bupivacaina liposomiale). L'accordo concede a Fresenius due licenze chiave:
1. Una licenza di volume che inizierà all'inizio del 2030, partendo da una percentuale a singolo numero alta del mercato statunitense, aumentando gradualmente fino a percentuali elevate negli anni finali.
2. Una licenza di volume illimitato che inizierà non prima del 2039.
L'accordo avviene prima della scadenza dell'ultimo brevetto di EXPAREL elencato nell'Orange Book di Pacira, prevista per il 2 luglio 2044. L'accordo risolve tutte le rivendicazioni in sospeso e include la presentazione di Giudizi di Consenso presso vari tribunali statunitensi per impedire a Fresenius di commercializzare versioni generiche prima dei termini concordati.
Pacira BioSciences (NASDAQ: PCRX) ha anunciado un acuerdo para resolver litigios de patentes con Fresenius Kabi USA y otras empresas sobre EXPAREL® (suspensión inyectable de bupivacaína liposómica). El acuerdo otorga a Fresenius dos licencias clave:
1. Una licencia de volumen que comenzará a principios de 2030, comenzando con un porcentaje de dígitos altos de los volúmenes del mercado estadounidense, aumentando gradualmente hasta alcanzar porcentajes altos en los últimos tres años.
2. Una licencia de volumen ilimitado que comenzará no antes de 2039.
El acuerdo se produce antes de la expiración, el 2 de julio de 2044, del último patente de EXPAREL listado en el Orange Book de Pacira. El acuerdo resuelve todas las reclamaciones pendientes e incluye la presentación de Juicios de Consentimiento en varios tribunales de EE. UU. para evitar que Fresenius comercialice versiones genéricas antes de lo acordado.
Pacira BioSciences (NASDAQ: PCRX)는 EXPAREL® (부피바카인 리포좀 주사 현탁액)에 대한 Fresenius Kabi USA 및 기타 회사와의 특허 소송을 해결하기 위한 합의를 발표했습니다. 이 합의는 Fresenius에게 두 가지 주요 라이센스를 부여합니다:
1. 2030년 초부터 시작되는 볼륨 라이센스, 미국 시장 볼륨의 높은 한 자리 수 비율로 시작하여 마지막 3년 동안 높은 30% 비율로 점차 증가합니다.
2. 2039년 이전에는 시작되지 않는 무제한 볼륨 라이센스.
이 합의는 Pacira의 마지막 Orange Book에 등재된 EXPAREL 특허가 2044년 7월 2일 만료되기 전에 체결되었습니다. 이 합의는 모든 미해결 청구를 해결하며, Fresenius가 합의된 조건 이전에 일반 버전을 판매하지 못하도록 하기 위해 여러 미국 법원에 동의 판결을 제출하는 것을 포함합니다.
Pacira BioSciences (NASDAQ: PCRX) a annoncé un règlement de litiges de brevets avec Fresenius Kabi USA et d'autres entreprises concernant EXPAREL® (suspension injectable de bupivacaïne liposomale). Le règlement accorde à Fresenius deux licences clés :
1. Une licence de volume commençant au début de 2030, débutant avec un pourcentage à un chiffre élevé des volumes du marché américain, augmentant progressivement jusqu'à un pourcentage élevé dans les trois dernières années.
2. Une licence de volume illimité commençant au plus tôt en 2039.
L'accord intervient avant l'expiration, le 2 juillet 2044, du dernier brevet EXPAREL répertorié dans l'Orange Book de Pacira. Le règlement résout toutes les réclamations en cours et inclut le dépôt de Jugements de Consentement auprès de divers tribunaux américains pour empêcher Fresenius de commercialiser des versions génériques avant les termes convenus.
Pacira BioSciences (NASDAQ: PCRX) hat eine Einigung über Patentstreitigkeiten mit Fresenius Kabi USA und anderen Unternehmen bezüglich EXPAREL® (bupivacain-haltige liposomale Injektionssuspension) bekannt gegeben. Die Einigung gewährt Fresenius zwei wichtige Lizenzen:
1. Eine Volumenlizenz, die Anfang 2030 beginnt, beginnend mit einem hohen einstelligen Prozentsatz des US-Marktes, der allmählich auf hohe zweistellige Prozentsätze in den letzten drei Jahren erhöht wird.
2. Eine unbegrenzte Volumenlizenz, die nicht vor 2039 beginnt.
Die Vereinbarung kommt vor dem Ablauf des letzten im Orange Book von Pacira gelisteten EXPAREL-Patents am 2. Juli 2044 zustande. Die Einigung löst alle ausstehenden Ansprüche und umfasst die Einreichung von Einwilligungsurteilen bei verschiedenen US-Gerichten, um zu verhindern, dass Fresenius generische Versionen vor den vereinbarten Bedingungen vermarktet.
- Patent litigation settlement provides clarity on EXPAREL market exclusivity until 2030
- Controlled generic entry with volume limitations protects majority market share through 2039
- Settlement validates strength of EXPAREL patent portfolio
- Generic competition will begin earlier than patent expiration (2030 vs 2044)
- Gradual loss of market share to generic version starting 2030
- Complete loss of exclusivity for EXPAREL by 2039
Insights
This patent settlement represents a strategic win for Pacira BioSciences regarding their key product EXPAREL. The agreement provides certainty around market exclusivity while allowing for a gradual, controlled generic entry rather than facing an abrupt patent cliff.
The settlement terms are notably favorable for Pacira. While they've compromised on the original July 2044 patent expiration date, they've secured full exclusivity until early 2030 - providing at least 5 more years of uncontested market presence. The subsequent volume- generic entry structure is particularly advantageous, starting with only high-single-digit percentage market penetration and gradually increasing to a maximum of high-thirties percentage by the final years, with unlimited generic entry postponed until 2039.
This structured approach to generic entry creates a "soft landing" for EXPAREL revenues instead of a steep revenue decline. Such arrangements are increasingly common in pharmaceutical patent settlements, but this one appears particularly favorable in its gradual scaling. By removing litigation uncertainty, management can now focus resources on their strategic initiatives rather than legal battles, potentially accelerating pipeline development to offset the eventual revenue impact when generics arrive in meaningful volumes.
-- Fresenius Kabi licensed to sell volume-limited amounts of generic bupivacaine liposome injectable suspension in the U.S. no earlier than a confidential date in 2030 --
-- Fresenius also licensed to sell generic bupivacaine liposome injectable suspension in the U.S. without volume limitations beginning in 2039 --
BRISBANE, Calif., April 07, 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 settled its litigations with Fresenius Kabi USA, LLC (Fresenius), Jiangsu Hengrui Pharmaceuticals Co., Ltd., and eVenus Pharmaceuticals Laboratories, Inc. related to patents for EXPAREL® (bupivacaine liposome injectable suspension).
As part of the settlement, the parties will file Consent Judgments with the United States Court of Appeals for the Federal Circuit and the United States District Courts for the District of New Jersey and the Northern District of Illinois that enjoin Fresenius from marketing generic bupivacaine liposome injectable suspension before the expiration of the patents-in-suit, except as provided for in the settlement described below.
In settlement of all outstanding claims in the litigations, Pacira has agreed to provide Fresenius with a license to Pacira’s patents required to manufacture and sell certain volume-limited amounts of generic bupivacaine liposome injectable suspension in the United States beginning on a confidential date that is sometime in early 2030. The license will permit entry of generic bupivacaine liposome injectable suspension before the July 2, 2044 expiration date of the last-to-expire of Pacira’s Orange Book-listed patents for EXPAREL.
While the agreed-upon volume-limited percentages are confidential, they begin at a high-single-digit percentage of the total volumes distributed in the U.S. market and increase gradually in each 12-month period following the volume-limited entry date until reaching a percentage in the low thirties in 2033 and increasing modestly in each of the next two 12-month periods before reaching a maximum percentage in the high thirties of the total volumes distributed in the U.S. for the final three years of the agreement. In addition, Pacira has agreed to provide Fresenius with a license to Pacira’s patents required to manufacture and sell an unlimited quantity of generic bupivacaine liposome injectable suspension in the U.S. beginning no earlier than 2039.
“We remain confident in our EXPAREL intellectual property portfolio and believe this settlement agreement appropriately recognizes the strength of our patents and provides clarity around EXPAREL exclusivity,” said Frank D. Lee, chief executive officer of Pacira. “With the litigation resolved, we look forward to focusing on advancing our 5x30 strategy and building upon our leadership position in musculoskeletal pain and adjacencies by developing new treatments that address the significant unmet needs of millions of Americans living with chronic pain.”
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, 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 “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” 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: the settlement described herein, ‘5x30’, our growth and business strategy; 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 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 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 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 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.
These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these statements. These factors include the matters discussed and referenced in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the SEC.
Investor Contact: Susan Mesco, (973) 451-4030 susan.mesco@pacira.com Media Contact: Sara Marino, (973) 370-5430 sara.marino@pacira.com
FAQ
When will Fresenius Kabi be allowed to sell generic EXPAREL in the US market?
What market share will Fresenius's generic EXPAREL be to initially?
How will Fresenius's EXPAREL generic market share change over time?
When does Pacira's last EXPAREL patent expire?
