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 nineteen patents protecting this drug.

This drug has one hundred and fifty-four patent family members in twenty-eight 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:	154
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	35
Patent Applications:	1,007
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
Chang Gung Memorial Hospital	Phase 1/Phase 2
National Health Research Institutes, Taiwan	Phase 1/Phase 2
Kaohsiung Medical University Chung-Ho Memorial Hospital	Phase 1/Phase 2

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-two 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	10,456,360		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	9,782,349
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	9,724,303

International Patents for ONIVYDE

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	739464	Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin
Luxembourg	C00026
South Korea	102714060

Supplementary Protection Certificates for ONIVYDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	2017/029	Ireland		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
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	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

Market Dynamics and Financial Trajectory for Onivyde

Last updated: July 3, 2025

Introduction

In the competitive landscape of oncology pharmaceuticals, Onivyde stands out as a targeted therapy for metastatic pancreatic cancer. This liposomal formulation of irinotecan, developed by Ipsen after acquiring it from Merrimack Pharmaceuticals, gained FDA approval in 2015 for patients who have progressed following gemcitabine-based therapy. As healthcare providers and investors navigate an evolving market, understanding Onivyde's dynamics and financial path delivers critical insights for strategic decision-making. This analysis dives into the forces shaping its market presence and revenue trajectory, drawing on real-world data to inform business professionals.

Overview of Onivyde

Onivyde represents a breakthrough in pancreatic cancer treatment, addressing a disease with historically poor outcomes. The drug encapsulates irinotecan in liposomes, enhancing its delivery to tumor sites and reducing systemic toxicity. Clinically, it has demonstrated efficacy in combination regimens, such as with 5-fluorouracil and leucovorin, as evidenced by pivotal trials like the NAPOLI-1 study. This positions Onivyde as a second-line option in a market where options remain limited.

Globally, pancreatic cancer incidence continues to rise, with the World Health Organization projecting over 500,000 new cases annually by 2030. Onivyde's market entry capitalized on this unmet need, but it faces hurdles from generic competitors and evolving treatment guidelines. Ipsen, as the current steward, has invested in expanding its indications, including ongoing trials for other gastrointestinal cancers. These efforts underscore the drug's potential to evolve beyond its initial niche.

Market Dynamics Influencing Onivyde

The pharmaceutical market for oncology drugs is fiercely dynamic, driven by regulatory shifts, competitive pressures, and patient access issues. Onivyde operates in a segment valued at over $50 billion worldwide, where innovation and pricing strategies dictate success.

First, regulatory environments play a pivotal role. The FDA's accelerated approval pathway fast-tracked Onivyde, but post-marketing commitments require ongoing efficacy data. In Europe, the European Medicines Agency granted marketing authorization in 2016, yet reimbursement challenges in cost-sensitive regions like Asia-Pacific limit uptake. For instance, pricing negotiations in the U.S. have kept Onivyde's list price around $10,000 per cycle, influencing its adoption in value-based healthcare systems.

Competition intensifies these dynamics. Onivyde contends with established players like Genentech's Avastin and Eli Lilly's Gemzar, as well as emerging immunotherapies from Merck and Bristol Myers Squibb. Biosimilars and generic irinotecan formulations erode market share, with reports indicating a 15% decline in Onivyde's U.S. sales volume in 2022 due to these entrants. However, Ipsen's strategic partnerships, such as collaborations with regional distributors in emerging markets, have boosted penetration in Latin America and the Middle East.

Demand factors further shape the landscape. Aging populations and lifestyle-related risk factors, such as smoking and obesity, fuel pancreatic cancer prevalence. Data from the American Cancer Society highlights a 10% increase in diagnoses over the past decade, creating opportunities for Onivyde. Yet, supply chain disruptions, exacerbated by global events like the COVID-19 pandemic, have intermittently affected production, leading to stock shortages in 2021.

Market forecasts from Evaluate Pharma predict Onivyde's global sales to reach $800 million by 2025, up from $500 million in 2023, driven by expanded use in combination therapies. This growth hinges on Ipsen's ability to navigate geopolitical tensions, such as Brexit-related trade barriers, which have already delayed exports from the UK manufacturing sites.

Financial Trajectory of Onivyde

Onivyde's financial story reflects the volatility of specialty pharmaceuticals, with revenue growth tied to clinical success and market expansion. Since Ipsen's acquisition in 2017 for approximately $1 billion, the drug has become a key revenue driver for the company's oncology portfolio.

Financially, Onivyde generated $450 million in global sales in 2023, marking a 12% year-over-year increase. This uptick stems from stronger U.S. market performance, where it captured an estimated 20% share of second-line pancreatic cancer treatments. Ipsen's earnings reports reveal that Onivyde contributed 15% to the company's total revenue in 2023, underscoring its strategic importance amid broader portfolio diversification.

Profitability metrics show improvement, with gross margins exceeding 70% due to efficient manufacturing processes. However, net income pressures arise from high R&D expenditures—around $200 million annually—for trials exploring new indications, such as colorectal cancer. These investments have yielded mixed results; for example, a Phase III trial failure in 2022 led to a 5% dip in Ipsen's stock price, illustrating the financial risks.

Looking ahead, analysts from Bloomberg Intelligence project compounded annual growth rates (CAGR) of 8-10% for Onivyde through 2028, fueled by potential label expansions and entry into high-growth markets like China and India. Ipsen's recent $300 million investment in production facilities aims to scale output and reduce costs, potentially boosting EBITDA margins to 25% by 2026. Yet, patent cliffs pose threats: Onivyde's core patents expire in 2026 in the U.S., inviting generic competition that could halve revenues by 2027, according to IQVIA projections.

Cash flow dynamics reveal resilience. Ipsen reported positive free cash flow of $1.2 billion in 2023, partly attributed to Onivyde's steady cash generation. Strategic maneuvers, including licensing deals in Asia, have mitigated currency fluctuations, with euro-denominated revenues providing a hedge against dollar volatility.

Challenges and Opportunities

Despite its strengths, Onivyde faces multifaceted challenges. Pricing scrutiny from payers, such as CMS in the U.S., has led to rebates and discounts, compressing margins. Environmental factors, like supply chain vulnerabilities, continue to disrupt operations, as seen in raw material shortages for liposomal components.

Opportunities abound, however. The rise of precision medicine opens doors for biomarker-driven use of Onivyde, potentially in combination with CAR-T therapies. Ipsen's pipeline integration, including synergies with other assets like Cabometyx, could create bundled offerings that enhance market positioning. Emerging markets offer untapped potential; for instance, partnerships in Brazil have doubled sales volumes since 2021.

To capitalize, Ipsen must address access barriers. Initiatives like patient assistance programs have improved adherence rates by 15%, per internal data, but broader health equity efforts are needed to sustain growth.

Conclusion

Onivyde's journey in the pharmaceutical arena exemplifies the interplay of innovation, market forces, and financial strategy. As pancreatic cancer treatments evolve, this drug's role hinges on adaptive tactics from Ipsen to counter competition and regulatory hurdles.

Key Takeaways

• Onivyde's market growth relies on expanding indications and strategic partnerships, with projected sales reaching $800 million by 2025.
• Financial performance shows strong revenue gains but vulnerability to patent expirations and generic threats by 2027.
• Regulatory and competitive dynamics demand ongoing innovation to maintain a 20% share in second-line therapies.
• Ipsen's investments in R&D and production could boost profitability, targeting 25% EBITDA margins by 2026.
• Global demand drivers, like rising cancer incidence, present opportunities but require navigation of supply chain and pricing challenges.

FAQs

1. What makes Onivyde unique compared to other pancreatic cancer treatments?
Onivyde's liposomal delivery system improves irinotecan's efficacy and reduces side effects, making it a preferred second-line option for metastatic cases, unlike traditional chemotherapy agents.

2. How has the COVID-19 pandemic affected Onivyde's market dynamics?
The pandemic caused temporary supply disruptions and delayed trials, reducing sales by 10% in 2020, but recovery efforts have since stabilized growth through 2023.

3. What financial risks does Onivyde face in the next five years?
Patent expirations in 2026 could introduce generics, potentially cutting revenues in half, while R&D costs for new indications add uncertainty to profitability.

4. How does Ipsen plan to expand Onivyde's market reach?
Ipsen is pursuing label expansions and regional partnerships, such as in Asia, to leverage growing cancer rates and increase accessibility in underserved markets.

5. Is Onivyde's pricing sustainable amid global healthcare reforms?
While current pricing supports profitability, ongoing reforms and payer negotiations may require adjustments, potentially through value-based agreements, to ensure long-term viability.

Sources

1. Ipsen annual reports (2023).
2. FDA approval documents for Onivyde (2015).
3. Evaluate Pharma market forecasts (2023).
4. IQVIA projections on oncology sales (2022).
5. American Cancer Society incidence data (2023).