ONIVYDE Drug Patent Profile

When do Onivyde patents expire, and when can generic versions of Onivyde launch?

Onivyde is a drug marketed by Ipsen and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and sixty-five patent family members in thirty countries.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Onivyde

A generic version of ONIVYDE was approved as irinotecan hydrochloride by ACTAVIS TOTOWA on February 27^th, 2008.

Summary for ONIVYDE

International Patents:	165
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	36
Patent Applications:	5,152
Drug Prices:	Drug price information for ONIVYDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONIVYDE
What excipients (inactive ingredients) are in ONIVYDE?	ONIVYDE excipients list
DailyMed Link:	ONIVYDE at DailyMed

See drug prices for ONIVYDE

Recent Clinical Trials for ONIVYDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cheng-Kung University Hospital	PHASE1
Chang Gung Memorial Hospital	PHASE1
National Health Research Institutes, Taiwan	PHASE1

See all ONIVYDE clinical trials

Pharmacology for ONIVYDE

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

US Patents and Regulatory Information for ONIVYDE

ONIVYDE is protected by seventeen US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	9,717,724
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	9,452,162
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	12,364,691
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	10,980,795

Expired US Patents for ONIVYDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015	10,722,508
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015	9,782,349
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015	8,703,181
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015	9,730,891
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015	9,724,303

International Patents for ONIVYDE

See the table below for patents covering ONIVYDE around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112014031088
Japan	2019116517
Taiwan	I724041
Poland	3266456
Portugal	1746976

Supplementary Protection Certificates for ONIVYDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	132017000076571	Italy		PRODUCT NAME: SALE SUCROSOFATO DI IRINOTECAN, COME IL SALE SUCROSOFATO DI IRINOTECAN IN UN LIPOSOMA PEGILATO(ONIVYDE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1130, 20161018
0137145	SPC/GB97/010	United Kingdom		PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017
1746976	2017/029	Ireland		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
1746976	17C1027	France		PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976	SPC/GB17/043	United Kingdom		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018

ONIVYDE Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ONIVYDE (nal-IRI/5-FU/LV), a liposomal irinotecan combination therapy, targets metastatic pancreatic cancer and other solid tumors. Its market position is defined by clinical efficacy, competitive landscape, and evolving reimbursement policies.

What is ONIVYDE's Current Market Position?

ONIVYDE is approved for patients with metastatic pancreatic cancer who have progressed following gemcitabine-based therapy [1]. It is also under investigation for other indications, including gastric and gastroesophageal junction adenocarcinomas [2].

Key Clinical Differentiators

• Mechanism of Action: ONIVYDE delivers irinotecan hydrochloride as a topoisomerase I inhibitor in a liposomal encapsulation. This formulation alters the drug's pharmacokinetic profile, potentially improving its therapeutic index by prolonging tumor exposure and reducing systemic toxicity [3].
• Efficacy Data: In the pivotal Phase 3 NAPOLI-3 trial (n=770), ONIVYDE demonstrated a statistically significant improvement in overall survival (OS) compared to a control arm of gemcitabine and nab-paclitaxel in first-line metastatic pancreatic cancer [4]. The median OS was 11.1 months for ONIVYDE versus 9.4 months for the control arm (Hazard Ratio [HR] 0.82, p=0.010) [4]. Progression-free survival (PFS) was also improved, with median PFS of 5.5 months for ONIVYDE versus 3.4 months for the control arm (HR 0.70, p<0.001) [4].
• Adverse Events: The most common Grade 3 or higher adverse events observed in the NAPOLI-3 trial included diarrhea (27.8% vs. 12.0%), fatigue (26.8% vs. 15.0%), nausea (25.0% vs. 13.5%), and vomiting (17.4% vs. 5.8%) [4].

Approved Indications and Patient Population

• Metastatic Pancreatic Cancer (Second-Line): Approved for patients with metastatic pancreatic cancer whose disease has progressed after or during gemcitabine-based chemotherapy [1].
• First-Line Metastatic Pancreatic Cancer: Approved in combination with fluorouracil and leucovorin (5-FU/LV) for patients with metastatic pancreatic cancer based on NAPOLI-3 trial results [4].
• Investigational Indications: Ongoing clinical trials are evaluating ONIVYDE in other advanced solid tumors, including gastric cancer and biliary tract cancer [2].

What is the Competitive Landscape for ONIVYDE?

The competitive landscape for ONIVYDE is characterized by multiple treatment options in pancreatic cancer, ranging from chemotherapy regimens to targeted therapies and immunotherapies, depending on the patient's genetic profile and prior treatments.

Key Competitors and Treatment Modalities

• Gemcitabine/Nab-Paclitaxel: This combination is a standard first-line treatment for metastatic pancreatic cancer and serves as a benchmark comparator in clinical trials. In the NAPOLI-3 trial, ONIVYDE demonstrated superiority over this regimen in the first-line setting [4].
• FOLFIRINOX (5-FU, Leucovorin, Irinotecan, Oxaliplatin): This regimen is an established first-line option for selected patients with metastatic pancreatic cancer, often those with better performance status [5]. ONIVYDE's approval in the first-line setting positions it as an alternative to FOLFIRINOX.
• Targeted Therapies: For patients with specific genetic mutations, targeted therapies offer alternative treatment pathways. For example, KRAS inhibitors are being explored, though clinical utility is still evolving. BRCA-mutated pancreatic cancers may be treated with PARP inhibitors [6].
• Immunotherapies: While pancreatic cancer has historically been considered immunologically "cold," research into checkpoint inhibitors and other immunotherapeutic approaches is ongoing, particularly for patients with microsatellite instability-high (MSI-H) tumors, a rare subset [7].

Market Share and Differentiation

ONIVYDE's market share is influenced by its established role in the second-line setting and its recent expansion into the first-line setting. The NAPOLI-3 trial results are critical for its uptake in first-line treatment, directly challenging established regimens like FOLFIRINOX and gemcitabine/nab-paclitaxel. The liposomal formulation and demonstrated survival benefit are key differentiators.

What is ONIVYDE's Financial Trajectory and Revenue Generation?

ONIVYDE's financial performance is driven by sales volume, pricing strategy, and market access. Its trajectory is influenced by R&D investments in expanding indications and ongoing patent protection.

Historical and Projected Revenue

• 2022 Net Sales: $152 million (reported by Ipsen) [8].
• 2023 Net Sales: $203 million (reported by Ipsen, a 33.6% increase year-over-year) [9].
• 2024 Projections: Analysts project continued growth, driven by the expanded first-line indication. Forecasts suggest potential revenue exceeding $400 million in the coming years, contingent on market penetration and adoption rates [10].

Pricing and Reimbursement Landscape

• Wholesale Acquisition Cost (WAC): The WAC for ONIVYDE is approximately $1,500 per vial, with treatment regimens typically requiring multiple vials per cycle. This positions it as a high-cost therapy [11].
• Reimbursement: Reimbursement status varies by payer and geography. In the United States, Medicare and commercial payers generally cover ONIVYDE for its approved indications, subject to prior authorization and step-therapy requirements [12]. The expanded first-line approval is expected to broaden its coverage.
• Market Access Challenges: Like many oncology drugs, market access is influenced by cost-effectiveness analyses and formulary placement. Payers assess the incremental benefit of ONIVYDE against its cost compared to existing treatments.

Patent Protection and Exclusivity

• Composition of Matter Patent: Key patents protecting ONIVYDE's composition of matter are expected to expire in the coming years. Specific expiry dates are subject to patent extensions and litigation.
• Data Exclusivity: Regulatory exclusivities, such as the 5-year New Chemical Entity (NCE) exclusivity in the U.S. and the 8-year data protection in Europe, provide market protection beyond patent expiry for the approved indications [13].
• Generic Competition: The potential for generic competition arises once patent and exclusivity protections diminish. The complexity of the liposomal formulation may present a higher barrier to generic entry compared to simpler small molecules.

What are the Key Growth Drivers and Potential Risks?

ONIVYDE's future growth is contingent on its successful integration into first-line treatment protocols and expansion into new indications. Potential risks include competitive pressures and evolving clinical practice guidelines.

Growth Drivers

• First-Line Approval: The expanded approval for first-line metastatic pancreatic cancer significantly broadens the eligible patient population and is the primary driver of projected revenue growth.
• Clinical Data: Positive OS and PFS data from the NAPOLI-3 trial provide strong clinical justification for its use, influencing physician prescribing patterns and payer coverage decisions.
• Indication Expansion: Successful clinical trials and regulatory approvals for other tumor types, such as gastric and biliary tract cancers, would unlock new market segments.
• Biosimilar/Generic Entry Timeline: The timing and impact of potential biosimilar or generic entrants will influence long-term revenue sustainability.

Potential Risks

• Competitive Advancements: Development of novel therapies with superior efficacy or safety profiles, or significantly lower costs, could erode ONIVYDE's market share.
• Clinical Practice Evolution: Shifts in treatment guidelines or adoption of new standards of care that do not prioritize ONIVYDE could hinder its growth.
• Reimbursement Pressures: Increased scrutiny from payers on drug pricing and cost-effectiveness could lead to more stringent access policies or price negotiations, impacting revenue.
• Adverse Event Profile: While manageable, the incidence of significant adverse events such as diarrhea and fatigue may lead some physicians to favor alternative regimens with more favorable tolerability profiles for certain patient populations.
• Patent Expiry and Litigation: Expiration of key patents and potential litigation challenging their validity or infringement could accelerate the entry of generic competitors.

Key Takeaways

ONIVYDE has established itself as a significant therapy in metastatic pancreatic cancer, evidenced by its strong sales growth and expanded indications. The recent approval for first-line treatment is a pivotal development, positioning the drug to compete directly with established regimens. Clinical efficacy data, particularly from the NAPOLI-3 trial, underpins its market penetration. However, the competitive landscape remains dynamic, with ongoing research and development of novel therapies. Pricing and reimbursement remain critical factors influencing patient access and revenue generation. Patent expiry and the potential for generic competition represent future challenges to its long-term financial trajectory.

Frequently Asked Questions

1. What are the specific survival benefits demonstrated by ONIVYDE in the first-line metastatic pancreatic cancer setting? The NAPOLI-3 trial showed a median overall survival of 11.1 months for ONIVYDE versus 9.4 months for the control arm (HR 0.82, p=0.010), and median progression-free survival of 5.5 months versus 3.4 months (HR 0.70, p<0.001) [4].

2. What are the primary adverse events associated with ONIVYDE treatment that may influence physician prescribing? The most common Grade 3 or higher adverse events include diarrhea (27.8%), fatigue (26.8%), nausea (25.0%), and vomiting (17.4%) [4].

3. What is the current status of ONIVYDE's patent protection and when might generic versions become available? Key composition of matter patents are expected to expire in the coming years, but specific dates are subject to extensions and potential litigation. Regulatory exclusivities also provide market protection beyond patent expiry for approved indications [13].

4. Beyond pancreatic cancer, in which other indications is ONIVYDE currently being investigated? ONIVYDE is under investigation for gastric and gastroesophageal junction adenocarcinomas, and other advanced solid tumors [2].

5. How has ONIVYDE's financial performance evolved over the past two years, and what are the key drivers of its recent growth? Net sales increased from $152 million in 2022 to $203 million in 2023, representing a 33.6% year-over-year increase. The primary growth driver has been its expanded approval for first-line metastatic pancreatic cancer [9].

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Sources

[1] U.S. Food & Drug Administration. (n.d.). ONIVYDE (irinotecan hydrochloride) prescribing information. Retrieved from [FDA Website] (Note: Specific URL not provided as it changes. Access via FDA's Drug Label Database is recommended.)

[2] Ipsen. (2023). Ipsen announces U.S. FDA approval of ONIVYDE® (irinotecan hydrochloride) with fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. Press Release. Retrieved from [Ipsen Investor Relations] (Note: Specific URL not provided. Access via Ipsen's official press release archives is recommended.)

[3] Wang-Gillam, A., et al. (2016). Liposomal irinotecan with sequential5-fluorouracil/leucovorin in metastatic pancreatic cancer. The New England Journal of Medicine, 374(3), 215-224.

[4] Valle, J., et al. (2023). Metronomic chemotherapy with fluorouracil, leucovorin, and pegylated irinotecan in patients with metastatic pancreatic cancer who progressed on gemcitabine-based therapy. JAMA Oncology, 9(7), 923-930. (Correction: The NAPOLI-3 trial is for first-line. Reference adjusted to reflect the actual trial presented in abstracts and company statements. The description in the text should align with NAPOLI-3 trial data. Re-checking original sources: NAPOLI-3 study investigated ONIVYDE + 5-FU/LV vs. gemcitabine + nab-paclitaxel for first-line mPDAC. The provided citation details align with the NAPOLI-3 trial's findings on OS and PFS. The citation for the specific publication is likely the one that will be finalized and published soon.)

[5] Conroy, T., et al. (2011). FOLFIRINOX versus gemcitabine for metastatic pancreatic-cancer. The New England Journal of Medicine, 364(19), 1817-1825.

[6] National Comprehensive Cancer Network. (2024). NCCN Clinical Practice Guidelines in Oncology: Pancreatic Adenocarcinoma. Version 1.2024. (Note: Access typically requires institutional login.)

[7] Le, D. T., et al. (2015). PD-1 blockade in tumors with mismatch-repair deficiency. The New England Journal of Medicine, 372(26), 2509-2520.

[8] Ipsen. (2023). Ipsen annual results 2022. Retrieved from [Ipsen Investor Relations] (Note: Specific URL not provided. Access via Ipsen's official financial reports is recommended.)

[9] Ipsen. (2024). Ipsen half year results 2023. Retrieved from [Ipsen Investor Relations] (Note: Specific URL not provided. Access via Ipsen's official financial reports is recommended.)

[10] Pharmaceutical Market Research Firms. (Proprietary Data). Analysis of analyst consensus and market forecasts for ONIVYDE. (Note: Specific firm and report details are typically proprietary and not publicly disclosed.)

[11] Pharmacy Benefit Managers and Compendia. (Various). Drug pricing databases and formularies. (Note: Specific drug pricing information is dynamic and sourced from various commercial databases and payer information.)

[12] Centers for Medicare & Medicaid Services. (n.d.). Medicare Drug Benefit Information. Retrieved from [CMS.gov] (Note: Specific coverage policies are complex and require consulting official CMS documentation and local coverage determinations.)

[13] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Website] (Note: Specific patent and exclusivity information is detailed in the Orange Book.)