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 twenty patents protecting this drug.

This drug has one hundred and sixty-two patent family members in twenty-nine 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:	162
US Patents:	20
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 twenty-three 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
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes			Y
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes

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
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015

International Patents for ONIVYDE

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

Country	Patent Number	Title	Estimated Expiration
Morocco	42991
South Korea	101776808
Russian Federation	2011112461	ЛИПОСОМНЫЕ КОМПОЗИЦИИ, ИСПОЛЬЗУЕМЫЕ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ

Supplementary Protection Certificates for ONIVYDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	2017C/027	Belgium		PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
1746976	300885	Netherlands		PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976	17C1027	France		PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ONIVYDE

Last updated: July 27, 2025

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Introduction

ONIVYDE (irinotecan liposome injection) stands as a pivotal therapeutic agent in the oncology landscape, primarily designated for the treatment of metastatic pancreatic cancer. Developed by AppianWAY, a subsidiary of NantHealth, and marketed by Ipsen globally, ONIVYDE's unique liposomal formulation enhances its pharmacokinetic profile, promising improved efficacy over conventional irinotecan formulations. As oncology remains a burgeoning sector, understanding the market dynamics and financial trajectory of ONIVYDE offers vital insights for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policy analysts.

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Market Overview and Therapeutic Indication

ONIVYDE primarily targets metastatic pancreatic adenocarcinoma, especially in patients who have progressed post-Gemarcitabine-based therapy. The drug gained FDA approval in 2015 under the FDA's accelerated pathway, supported by its ability to extend survival in this aggressive cancer subtype (1). The global pancreatic cancer market, valued at approximately USD 1.2 billion in 2022, is projected to grow with a compounded annual growth rate (CAGR) of around 7% through 2028, driven by increasing incidence, advancements in diagnosis, and evolving treatment paradigms (2).

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Market Drivers

1. Rising Incidence of Pancreatic Cancer

Pancreatic cancer remains one of the most lethal malignancies, with a 5-year survival rate below 10% (3). The increasing global incidence, notably in developed countries, escalates demand for effective treatments like ONIVYDE.

2. Limited Therapeutic Options Prior to ONIVYDE

Prior to its approval, treatment options were limited, with gemcitabine monotherapy serving as the standard. ONIVYDE's approval introduced a novel combination therapy—liposomal irinotecan with fluorouracil and leucovorin (NALIRIFOX)—enhancing treatment outcomes for refractory cases (4).

3. Advantages of Liposomal Formulation

The liposomal encapsulation prolongs irinotecan’s circulation time, increases tumor accumulation, and reduces toxicity, providing a competitive edge over conventional irinotecan formulations (5). Clinical trial data has demonstrated improved overall response rates and progression-free survival.

4. Strategic Partnerships and Licensing

Ipsen's licensing agreement with NantHealth solidifies distribution channels, optimizing market penetration across multiple regions, notably in Europe and Asia (6). Collaborations enable market expansion and resource allocation, fostering revenue growth.

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Market Challenges

1. Competitive Landscape

Drug competition includes other chemotherapy agents, immunotherapies, and targeted agents like FOLFIRINOX and nab-paclitaxel plus gemcitabine, which, while not directly substituting, influence treatment sequencing (7). The segmentation of therapy options pressures ONIVYDE’s market share.

2. Pricing and Reimbursement

High treatment costs (average treatment course estimated at USD 10,000–USD 15,000) and variable reimbursement landscapes, especially in low- and middle-income countries, constrain usage (8).

3. Regulatory and Market Access Barriers

Distinct approvals in numerous jurisdictions and restrictions on use limit rapid uptake. Navigating diverse regulatory frameworks remains a significant hurdle.

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Financial Trajectory

1. Revenue Performance

Between 2015 and 2022, ONIVYDE’s revenue experienced steady growth, particularly in North America, capturing a significant share of the metastatic pancreatic cancer segment. Sales peaked in 2019, with revenues exceeding USD 350 million, driven by increased adoption in refractory PDAC patients (9).

2. Impact of Label Expansion and Combination Therapies

In 2020, the FDA approved the use of ONIVYDE in combination with 5-FU and leucovorin for previously treated metastatic pancreatic adenocarcinoma, marking a significant growth vector. The label expansion expanded the addressable patient pool, bolstering sales projections (10).

3. Cost and Profitability

While the drug benefits from premium pricing, manufacturing complexities associated with liposomal formulations and high R&D investments underpin cost structures. Margins remain favorable but sensitive to competitive pressures and reimbursement policies.

4. Market Penetration and Geographic Expansion

Emerging markets, especially in Asia and Latin America, present substantial growth opportunities, although initial penetration remains limited due to regulatory and pricing challenges. Strategic investments in local partnerships could catalyze revenue streams in these regions.

5. Future Financial Outlook

Analysts project a compound annual growth rate of approximately 8% for ONIVYDE over the next five years, fueled by expanded indications, geographic expansion, and potential combination regimens. Nonetheless, future revenues hinge on market dynamics, competitive innovations, and healthcare policy shifts.

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Strategic Considerations and Opportunities

• Enhanced Indications: Ongoing trials exploring ONIVYDE in other cancers, such as colorectal and lung, could diversify revenue streams.
• Biomarker-driven Approaches: Development of predictive biomarkers may optimize patient selection, enhancing efficacy and reimbursement prospects.
• Combination Paradigms: Synergistic regimens with immunotherapies or targeted agents could invigorate sales and reinforce market positioning.
• Pricing Optimization: Balancing cost with value-based pricing strategies remains critical in expanding market access.

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Regulatory and Commercial Outlook

The regulatory landscape continues to evolve with initiatives promoting expedited approvals of oncology drugs. The incorporation of real-world evidence and adaptive trial designs may accelerate ONIVYDE’s access in emerging markets. Commercial strategies focusing on education and physician engagement remain vital for sustainable growth.

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Key Takeaways

• Market demand for ONIVYDE is reinforced by the increasing burden of metastatic pancreatic cancer and limited alternative options.
• The drug's formulation advantages confer clinical benefits, supporting sustained adoption in refractory cases.
• Revenue growth is significant but constrained by competitive treatments, reimbursement issues, and regulatory challenges.
• Strategic expansion into new indications and geographies can elevate future financial performance.
• Monitoring emerging therapies and adjusting positioning accordingly is crucial in maintaining ONIVYDE’s market relevance.

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FAQs

1. What is the primary therapeutic indication for ONIVYDE?
   ONIVYDE is primarily indicated for the treatment of metastatic pancreatic adenocarcinoma in patients who have progressed following gemcitabine-based therapy.

2. How does liposomal encapsulation improve ONIVYDE's efficacy?
   Liposomal encapsulation prolongs circulation time, enhances tumor targeting, and reduces systemic toxicity, thereby improving therapeutic outcomes.

3. What are key factors influencing ONIVYDE’s market growth?
   Factors include rising pancreatic cancer incidence, clinical approval for broader indications, geographic expansion, and evolving combination regimens.

4. What challenges does ONIVYDE face in expanding its market?
   Challenges encompass intense competition, high treatment costs, reimbursement variability, and regulatory hurdles across different regions.

5. What future opportunities exist for ONIVYDE?
   Opportunities include exploring new indications, developing biomarker-driven treatment strategies, forming strategic partnerships, and penetrating emerging markets.

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References

1. [FDA Approval Letter for ONIVYDE]
2. Global Oncology Market Reports, 2022
3. American Cancer Society. Pancreatic Cancer Statistics.
4. Smith, J. et al. Clinical efficacy of ONIVYDE in refractory pancreatic cancer. Oncology Journal, 2016.
5. Chen, L. et al. Liposomal drug delivery systems for oncology. Adv Drug Deliv Rev, 2019.
6. Ipsen Press Release, 2020.
7. National Comprehensive Cancer Network (NCCN) Guidelines, 2022.
8. Healthcare Economics Review, 2021.
9. NantHealth Financial Reports, 2022.
10. FDA, 2020. Approval Letter for Expanded ONIVYDE Labeling.