ONIVYDE Drug Patent Profile

Which patents cover Onivyde, and what generic alternatives are available?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONIVYDE

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
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	10,993,914		Y

International Patents for ONIVYDE

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2015100529	СПОСОБЫ ЛЕЧЕНИЯ РАКА ПОДЖЕЛУДОЧНОЙ ЖЕЛЕЗЫ С ПРИМЕНЕНИЕМ КОМБИНИРОВАННОЙ ТЕРАПИИ, ВКЛЮЧАЮЩЕЙ ЛИПОСОМНЫЙ ИРИНОТЕКАН
Canada	3006109	LIPOSOMES POUR L'ADMINISTRATION DE DROGUES CONTENANT DES POLYOLS ANIONIQUES OU DES SUCRES ANIONIQUES (DRUG DELIVERY LIPOSOMES CONTAINING ANIONIC POLYOLS OR ANIONIC SUGARS)
South Korea	20170104638	리포좀성 이리노테칸을 포함하는 병용 치료요법을 사용하여 췌장암을 치료하기 위한 방법 (METHODS FOR TREATING PANCREATIC CANCER USING COMBINATION THERAPIES COMPRISING LIPOSOMAL IRINOTECAN)
Taiwan	I778942
Spain	3036518
Taiwan	202400181	Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal IRINOTECAN and OXALIPLATIN
Japan	6310911

Supplementary Protection Certificates for ONIVYDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	C01746976/01	Switzerland		PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
1746976	2017/029	Ireland		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
1746976	CA 2017 00030	Denmark		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
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
1746976	122017000042	Germany		PRODUCT NAME: LRINOTECAN SUCROSOFAT-SALZ, WIE Z.B. LRINOTECAN SUCROSOFAT-SALZ IN EINEM PEGYLIERTEN LIPOSOM WIE BEISPIELWEISE EINEM LIPOSOM, DAS 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLIN, CHOLESTERIN UND N-(OMEGA-METHOXYPOLY(ETHYLENGLYKOL) (MOLEKULARGEWICHT 2000)OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYLETHANOLAMIN Z.B. IM MOLVERHAELTNIS 3:2:0,015 UMFASST.; REGISTRATION NO/DATE: EU/1/16/1130 20161014
1746976	LUC00026	Luxembourg		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: 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

ONIVYDE (irinotecan liposomal injection): Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

What is ONIVYDE?

ONIVYDE (irinotecan liposomal injection) is approved by the FDA for the treatment of metastatic pancreatic adenocarcinoma after at least one prior chemotherapy regimen. It encapsulates irinotecan in liposomes, enabling targeted delivery and improved pharmacokinetics over conventional formulations.

Market Position and Commercial Overview

The drug is marketed by Ipsen and Taiho Pharmaceutical. In 2022, ONIVYDE generated approximately $68 million in U.S. sales, reflecting its niche but potentially expanding market due to its targeted indication.

Regulatory Status and Approvals

• FDA: Approved in 2015 for metastatic pancreatic cancer.
• EMA: Approved in Europe for similar indications.
• Other Markets: Limited approvals outside North America and Europe; potential for regional expansion.

Market Dynamics and Competitive Landscape

• Key Competitors: Other second-line agents for pancreatic cancer such as FOLFIRINOX, gemcitabine/nab-paclitaxel.
• Market Size: Approximately 60,000 new deaths annually from pancreatic cancer in the U.S. (ASCO, 2021).
• Growth Drivers: Rising incidence, limited treatment options post first-line failure, increasing clinical adoption.

Revenue Drivers and Sales Potential

Factor	Impact
Treatment Line	Mainly second-line, limiting volume but targeting severe cases
Pricing	Approx. $12,000 per treatment cycle; high margin but constrained by payor policies
Clinical Trials	Ongoing studies could expand indications (e.g., other gastrointestinal cancers)
Market Penetration	Depends on physician adoption, reimbursement, and regional approvals

Clinical and R&D Pipeline

• Ongoing Trials: Some phase 2 trials for indications like metastatic colorectal cancer and ovarian cancer.
• Potential Expansion: Positive results could diversify revenue streams.
• Limitations: No current pipeline products in late-stage development by Ipsen or Taiho focused explicitly on ONIVYDE.

Investment Risks and Challenges

• Competitive Pressure: Small patient population; other chemotherapeutics and targeted agents continuously emerging.
• Regulatory Risks: Future approvals depend on confirming efficacy in new indications.
• Market Penetration: Discounted reimbursement rates may limit revenue growth.
• Pipeline Limitations: Lack of substantial pipeline innovation could hinder long-term growth.

Financial Outlook

• Revenue Estimates: Flat to modest growth projected through 2025 unless expansion efforts succeed.
• Profitability: Likely maintained due to high margins on niche product, but growth margins depend on sales volume and pricing.

Strategic Considerations

• Partnerships: Collaboration with payers for better reimbursement policies.
• Clinical Development: Focus on validating additional indications through clinical trials.
• Regional Expansion: Prioritize regulatory filings in Asia, Latin America.

Key Takeaways

• ONIVYDE remains a niche chemotherapy option with limited but steady revenue.
• Its growth prospects hinge on expanding indications and regional approvals.
• Competition from other chemotherapeutic agents and emerging targeted therapies caps upside.
• Limited pipeline reduces long-term growth potential.

FAQ

Q1: What is ONIVYDE’s primary indication?
A1: Treatment of metastatic pancreatic adenocarcinoma in patients who have received at least one prior chemotherapy regimen.

Q2: What are the main revenue drivers?
A2: Second-line treatment adoption, high treatment cycle pricing, and payer coverage.

Q3: What are the key risks?
A3: Competition, regulatory hurdles, limited pipeline, and reimbursement challenges.

Q4: Can ONIVYDE’s indications expand?
A4: Ongoing trials for other gastrointestinal cancers could lead to expanded approvals if results are positive.

Q5: How does the pipeline influence future investment?
A5: Limited late-stage pipeline diminishes long-term growth prospects without new indications or formulations.

References

1. American Society of Clinical Oncology. (2021). Pancreatic cancer statistics.
2. Bloomberg Intelligence. (2023). Oncology drug market overview.
3. FDA. (2015). ONIVYDE approval documentation.
4. Ipsen. (2022). Annual financial report.
5. EMA. (2022). ONIVYDE authorization details.