Avadel Pharmaceuticals and Jazz Pharmaceuticals Reach Global Settlement
Avadel Pharmaceuticals (NASDAQ:AVDL) announced a global settlement with Jazz Pharmaceuticals resolving all litigation and mutually dismissing lawsuits with prejudice.
Key terms include a $90 million payment from Jazz to Avadel, Jazz's waiver of royalties/damages on LUMRYZ sales through September 30, 2025, and a perpetual worldwide license from Jazz covering patents that could be asserted against LUMRYZ for all indications. Avadel will pay Jazz ongoing royalties of 3.85% of net narcolepsy sales (possible reduction to 3.75%) starting October 1, 2025, and 10% royalties (possible reduction to 9.5%) on LUMRYZ for any future FDA-approved indications beginning no earlier than March 1, 2028, both through February 18, 2036.
Avadel Pharmaceuticals (NASDAQ:AVDL) ha annunciato un accordo globale con Jazz Pharmaceuticals che risolve tutte le controversie e ritira reciprocamente le cause con effetto definitivo.
Termini chiave includono un pagamento di 90 milioni di dollari da Jazz ad Avadel, la rinuncia da parte di Jazz a royalty/danni sulle vendite di LUMRYZ fino al 30 settembre 2025, e una licenza mondiale perpetua da Jazz che copre i brevetti che potrebbero essere fatti valere contro LUMRYZ per tutte le indicazioni. Avadel pagherà a Jazz royalty continue pari al 3,85% delle vendite nette di narcolessia (riduzione possibile a 3,75%) a partire dal 1 ottobre 2025, e royalty del 10% (riduzione possibile a 9,5%) su LUMRYZ per eventuali future indicazioni approvate dalla FDA, non prima del 1 marzo 2028, entrambe fino al 18 febbraio 2036.
Avadel Pharmaceuticals (NASDAQ:AVDL) anunció un acuerdo global con Jazz Pharmaceuticals que resuelve toda la litigación y desestima mutuamente las demandas con efecto definitivo.
Los términos clave incluyen un pago de 90 millones de dólares de Jazz a Avadel, la renuncia por parte de Jazz a regalías/daños sobre las ventas de LUMRYZ hasta el 30 de septiembre de 2025, y una licencia mundial perpetua de Jazz que cubre patentes que podrían hacerse valer contra LUMRYZ para todas las indicaciones. Avadel pagará a Jazz regalías continuas del 3,85% de las ventas netas de narcolepsia (posible reducción a 3,75%) a partir del 1 de octubre de 2025, y regalías del 10% (posible reducción a 9,5%) sobre LUMRYZ para cualquier indicación futura aprobada por la FDA, a partir no antes del 1 de marzo de 2028, ambas hasta el 18 de febrero de 2036.
Avadel Pharmaceuticals (NASDAQ:AVDL)은 Jazz Pharmaceuticals와의 전 세계 합의를 발표하여 모든 소송을 해결하고 양측이 소송을 기각하기로 상호 합의했습니다.
주요 조건에는 Jazz가 Avadel에 9000만 달러를 지급하고, LUMRYZ 매출에 대한 로열티/손해 배상의 면제가 2025년 9월 30일까지 연장되며, Jazz가 LUMRYZ를 모든 적응증에 대해 도전할 수 있는 특허를 포함하는 세계적이고 영구적인 라이선스를 부여한다는 내용이 포함됩니다. Avadel은 2025년 10월 1일부터 순 narcolepsy 매출의 순매출 기준 3.85%의 로열티를 Jazz에 지속 지급하고, 9.5%로 축소될 수 있는 가능성을 포함한 3.75%로의 축소 가능성이 있으며, FDA가 향후 승인하는 적응증에 대해 LUMRYZ에 대한 10%의 로열티(가능 축소 9.5%)를 2028년 3월 1일 이후 시작하여 2036년 2월 18일까지 지급합니다.
Avadel Pharmaceuticals (NASDAQ:AVDL) a annoncé un règlement global avec Jazz Pharmaceuticals qui résout tous les litiges et retire mutuellement les poursuites avec effet définitif.
Les termes clés comprennent un paiement de 90 millions de dollars de Jazz à Avadel, la renonciation par Jazz aux redevances/dommages sur les ventes de LUMRYZ jusqu’au 30 septembre 2025, et une licence mondiale perpétuelle de Jazz couvrant les brevets qui pourraient être invoqués contre LUMRYZ pour toutes les indications. Avadel versera à Jazz des redevances continues de 3,85% des ventes nettes de narcolepsie (réduction possible à 3,75%) à partir du 1er octobre 2025, et des redevances de 10% (réduction possible à 9,5%) sur LUMRYZ pour toute indication future approuvée par la FDA, à compter du 1er mars 2028, et ce jusqu’au 18 février 2036.
Avadel Pharmaceuticals (NASDAQ:AVDL) kündigte eine globale Einigung mit Jazz Pharmaceuticals an, die alle Rechtsstreitigkeiten beendet und gegenseitig Klagen mit Vorurteil fallen lässt.
Zu den Kernbedingungen gehört eine Zahlung von 90 Millionen USD von Jazz an Avadel, der Verzicht von Jazz auf Royaltys/Schäden aus dem Verkauf von LUMRYZ bis zum 30. September 2025, sowie eine weltweite, unbefristete Lizenz von Jazz, die Patente umfasst, die gegen LUMRYZ für alle Indikationen geltend gemacht werden könnten. Avadel wird Jazz fortlaufend Royaltys von 3,85% des Nettoumsatzes bei Narkolepsie zahlen (mögliche Reduktion auf 3,75%) ab dem 1. Oktober 2025, und Royaltys von 10% (mögliche Reduktion auf 9,5%) auf LUMRYZ für künftig von der FDA genehmigte Indikationen, beginnend frühestens zum 1. März 2028, bis zum 18. Februar 2036.
Avadel Pharmaceuticals (NASDAQ:AVDL) أعلنت تسوية عالمية مع Jazz Pharmaceuticals تقضي على جميع الدعاوى وتُسقط الدعاوى المتبادلة مع حفظ الحقوق.
يشمل البنود الأساسية دفعة قدرها 90 مليون دولار من Jazz إلى Avadel، وتخلي Jazz عن العوائد/الأضرار من مبيعات LUMRYZ حتى 30 سبتمبر 2025، ورخصة عالمية دائمة من Jazz تغطي براءات يمكن أن تُرفع ضد LUMRYZ لكافة المؤشرات. ستدفع Avadel إلى Jazz عوائد مستمرة بنسب 3.85% من صافي مبيعات الناروكلِيبْسيا (قد تُخفض إلى 3.75%) ابتداءً من 1 أكتوبر 2025، وعوائد قدرها 10% (قد تُخفض إلى 9.5%) على LUMRYZ لأي مؤشرات مستقبلية معتمدة من FDA ابتداءً من 1 مارس 2028، وكلاهما حتى 18 فبراير 2036.
Avadel Pharmaceuticals (NASDAQ:AVDL) 公布与 Jazz Pharmaceuticals 的全球和解，解决所有诉讼并相互撤诉，具有排他性效力。
关键条款包括 Jazz 向 Avadel 支付 9000万美元、Jazz 放弃对 LUMRYZ 销售的特许权使用费/损害赔偿至 2025年9月30日，以及 Jazz 授予的涵盖可对 LUMRYZ 提起的所有适应症的全球性永久许可。自 2025年10月1日起，Avadel 将向 Jazz 支付 LUMRYZ 的净癫痫销量 3.85% 的持续特许费（可能降至 3.75%），并就未来经 FDA 批准的适应症对 LUMRYZ 收取 10% 的特许费（可能降至 9.5%），起始时间不早于 2028年3月1日，并一直持续至 2036年2月18日。
- Jazz to pay Avadel $90 million
- Jazz waived royalty claims on LUMRYZ through Sept 30, 2025
- Perpetual worldwide license for LUMRYZ patents from Jazz
- Cleared pathway to sell LUMRYZ for idiopathic hypersomnia from Mar 1, 2028
- Avadel obligated to pay 3.85% royalties on narcolepsy sales from Oct 1, 2025
- Avadel faces 10% royalty on future indications from Mar 1, 2028 until Feb 18, 2036
- Avadel granted Jazz a perpetual royalty-free covenant not to sue for Xywav/Xyrem
Insights
Settlement removes major IP overhang, secures $90 million, and defines royalty terms and an earliest entry date for new indications.
By exchanging a perpetual license from Jazz and a $90 million payment, Avadel obtains freedom to operate for LUMRYZ across current and future indications and presentations, while Jazz receives a perpetual covenant not to sue for its Xywav/Xyrem patents. The deal also sets explicit commercial economics: a
The primary business effect is reduced litigation risk and clearer commercialization pathways, with a defined earliest date for launching LUMRYZ into new FDA-approved indications. Key dependencies include actual regulatory approval timelines for any new indication and the magnitude of future sales subject to the stated royalties. Watch for the company 8-K and any FDA filings that confirm an approval timeline; expect material commercial implications to emerge by
DUBLIN, Oct. 22, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the global settlement of all litigation with Jazz Pharmaceuticals Inc. (“Jazz”).
Under the primary terms of the settlement agreement, Avadel and Jazz will dismiss their respective lawsuits with prejudice. Furthermore, Jazz agrees to grant Avadel the following:
- A perpetual, worldwide license to any past, present, or future patents that could be asserted against LUMRYZ for any and all present and future indications, strengths, conditions of use, dosages, doses, dosage forms, and presentations.
- Jazz will make a payment of
$90 million to Avadel and waive its right to receive royalties and/or damages on past sales of LUMRYZ through September 30, 2025. - Jazz has agreed not to challenge the approvability of LUMRYZ for any and all present and future indications (e.g., idiopathic hypersomnia).
- Beginning no earlier than March 1, 2028, LUMRYZ can be sold for any future FDA approved indication (e.g., idiopathic hypersomnia).
Additionally, under the primary terms of the settlement agreement, Avadel agrees to grant Jazz the following:
- A perpetual worldwide, royalty-free, fully paid-up covenant not to sue pertaining to Avadel’s patents in connection with Jazz’s Xywav and Xyrem products for any and all present and future indications, strengths, conditions of use, dosages, doses, dosage forms, and presentations.
- As of October 1, 2025, Avadel will be obligated to pay Jazz ongoing royalties of
3.85% (subject to potential reduction to3.75% ) of net sales of LUMRYZ in narcolepsy through February 18, 2036. - Beginning no earlier than March 1, 2028, LUMRYZ sold for any future FDA approved indication will be subject to a royalty of
10% (subject to potential reduction to9.5% ) of net sales until February 18, 2036.
This settlement provides Avadel with long-term clarity on its intellectual property position and commercial rights. With a defined pathway for LUMRYZ in idiopathic hypersomnia, including a certain entry date as early as March 1, 2028, we believe Avadel is well-positioned to advance its differentiated sleep medicines portfolio.
Further details regarding the terms of the settlement agreement can be found in the Company’s corresponding 8-K that was filed with the United States Securities and Exchange Commission (SEC) on October 22, 2025.
About LUMRYZ™ (sodium oxybate) for extended-release oral suspension
LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients seven years of age and older with narcolepsy.
The FDA approval of LUMRYZ was supported by results from REST-ON™, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.
With its approvals in May 2023 and October 2024, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients seven years of age and older with narcolepsy respectively due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
LUMRYZ is only currently approved for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy, and Avadel does not market, promote or support LUMRYZ for any indication beyond narcolepsy.
INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients seven years of age and older with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy)
- excessive daytime sleepiness (EDS)
IMPORTANT SAFETY INFORMATION
| WARNING: Taking LUMRYZ™ (sodium oxybate) with other central nervous system (CNS) depressants, such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope) and death. The active ingredient of LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma and death. Call your doctor right away if you have any of these serious side effects. Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029. |
Do not take LUMRYZ if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase deficiency.
Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.
Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
LUMRYZ can cause serious side effects, including the following:
- Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.
- Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself. Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite.
- Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child start sleepwalking.
Tell your doctor if you or your child are on a salt-restricted diet or have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.
The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. The most common side effects in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking.
LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ.
For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including BOXED Warning.
About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. For more information, please visit www.avadel.com.
Avadel intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcast.
Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the potential benefits resulting from the settlement with Jazz and the timing of sales of LUMRYZ in idiopathic hypersomnia. In some cases, forward-looking statements can be identified by use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable).
The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission.
Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
Investor Contact:
Austin Murtagh
Precision AQ
Austin.Murtagh@precisionAQ.com
(212) 698-8696
Media Contact:
Alyssa Ramirez
Real Chemistry
aramirez@realchemistry.com
FAQ
What did Avadel (AVDL) and Jazz agree on October 22, 2025?
How much will Jazz pay Avadel under the AVDL settlement and when is the waiver effective?
What royalties will Avadel (AVDL) pay Jazz for LUMRYZ narcolepsy sales and when do they start?
When can Avadel (AVDL) sell LUMRYZ for new FDA-approved indications like idiopathic hypersomnia?
What royalty will Avadel (AVDL) pay on future LUMRYZ indications after March 1, 2028?
How does the settlement affect Avadel's intellectual property position for LUMRYZ?
