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:	36
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
Kaohsiung Medical University Chung-Ho Memorial Hospital	Phase 1/Phase 2
Taipei Veterans General Hospital, Taiwan	Phase 1/Phase 2
China Medical University 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
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

International Patents for ONIVYDE

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

Country	Patent Number	Title	Estimated Expiration
Poland	1746976
Slovenia	3337478
Taiwan	202126293

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
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	SPC/GB17/043	United Kingdom		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018

Market Dynamics and Financial Trajectory for ONIVYDE

Introduction

ONIVYDE, a liposomal irinotecan formulation, has been a significant player in the oncology market, particularly in the treatment of metastatic pancreatic cancer. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key milestones, regulatory approvals, and financial implications.

Regulatory Approvals and Milestones

Initial Approval

ONIVYDE received its first FDA approval in October 2015 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have progressed following gemcitabine-based therapy, in combination with fluorouracil and leucovorin[3].

Recent Approval

In February 2024, the FDA approved ONIVYDE as part of a multidrug combination called NALIRIFOX (Onivyde plus oxaliplatin, fluorouracil, and leucovorin) as a first-line treatment for adults with newly diagnosed metastatic pancreatic ductal adenocarcinoma (mPDAC). This approval marked the first new regimen for first-line treatment of pancreatic cancer in over 10 years[1][4].

Market Impact

Unmet Medical Need

Pancreatic cancer is notoriously difficult to treat, with few approved therapies. The approval of ONIVYDE as a first-line treatment addresses a significant unmet medical need, offering patients a new and potentially more effective treatment option[4].

Competitive Landscape

The approval of NALIRIFOX could alter the competitive landscape in pancreatic cancer treatments. It has shown a 16% reduction in the risk of death and a 30% reduction in the risk of tumor progression or death compared to traditional chemotherapy combinations, making it a strong contender in the market[4].

Financial Trajectory

Acquisition and Initial Investment

Ipsen acquired the oncology assets, including ONIVYDE, from Merrimack Pharmaceuticals in 2017 for $575 million upfront, plus up to $450 million in potential milestones based on label expansions. This acquisition was seen as a strategic move to strengthen Ipsen’s oncology portfolio[3].

Milestone Payments

The recent FDA approval of ONIVYDE as a first-line treatment triggered a $225 million milestone payment from Ipsen to Merrimack. This payment is substantial for Merrimack, given its reported cash position of $18.9 million as of December 31, 2023[2][4].

Sales Projections

Analysts project that ONIVYDE's sales will grow significantly, from 164 million euros in 2023 to 265 million euros in 2025. Ipsen believes the drug could eventually reach peak sales of 500 million euros by expanding its share in both front-line and post-chemo settings[4].

Impact on Ipsen’s Financials

The strong performance of ONIVYDE, along with other growth platforms and new medicines, has contributed to Ipsen’s solid financial growth. In the first quarter of 2024, Ipsen reported a total sales growth of 13.3% at constant exchange rates, driven partly by the 16.2% increase in sales of the growth platforms, which include ONIVYDE[1].

Impact on Merrimack’s Financials

For Merrimack, the milestone payment from Ipsen has significant implications. The company plans to dissolve in May 2024 and issue a liquidating dividend to its shareholders, estimated between $14.65 and $15.35 per share. This move reflects Merrimack’s assessment that no further milestone payments are expected from the agreements with Ipsen and Elevation Oncology[2].

Future Outlook

Growth and Expansion

Ipsen’s strategy includes leveraging ONIVYDE’s success to drive further growth. The company aims to achieve annual sales growth of at least 7% between 2023 and 2027 at constant exchange rates, partly driven by the expanded use of ONIVYDE in both front-line and post-chemo settings[4].

Patent Cliff and Future Developments

ONIVYDE is expected to face a patent cliff towards the end of 2027. To mitigate this, Ipsen is focusing on additional business development deals and external innovation transactions to drive its next phase of growth. The company has significant deal-making firepower, with 1.9 billion euros available for potential transactions as of the end of 2023[4].

Key Takeaways

• Regulatory Approvals: ONIVYDE has received significant regulatory approvals, including a recent FDA approval as a first-line treatment for mPDAC.
• Market Impact: The drug addresses a high unmet medical need in pancreatic cancer and is poised to alter the competitive landscape.
• Financial Trajectory: The drug has triggered substantial milestone payments and is projected to see significant sales growth.
• Company Implications: The success of ONIVYDE is crucial for Ipsen’s financial growth and has led to a planned dissolution and liquidating dividend for Merrimack.
• Future Outlook: Ipsen is leveraging ONIVYDE’s success to drive growth and is preparing for future challenges such as the patent cliff.

FAQs

What is ONIVYDE and how is it used?

ONIVYDE is a liposomal irinotecan formulation used in the treatment of metastatic pancreatic cancer. It has been approved for use in combination with other chemotherapies as a first-line treatment for newly diagnosed patients and for those who have progressed following gemcitabine-based therapy.

What was the recent FDA approval for ONIVYDE?

In February 2024, the FDA approved ONIVYDE as part of the NALIRIFOX regimen (Onivyde plus oxaliplatin, fluorouracil, and leucovorin) as a first-line treatment for adults with newly diagnosed metastatic pancreatic ductal adenocarcinoma (mPDAC).

How much did Ipsen pay for the acquisition of ONIVYDE?

Ipsen acquired the oncology assets, including ONIVYDE, from Merrimack Pharmaceuticals in 2017 for $575 million upfront, plus up to $450 million in potential milestones based on label expansions.

What is the projected sales growth for ONIVYDE?

Analysts project that ONIVYDE's sales will grow from 164 million euros in 2023 to 265 million euros in 2025. Ipsen believes the drug could eventually reach peak sales of 500 million euros.

What is the impact of ONIVYDE’s approval on Merrimack Pharmaceuticals?

The approval triggered a $225 million milestone payment from Ipsen to Merrimack, which is significant given Merrimack’s cash position. Merrimack plans to dissolve and issue a liquidating dividend to its shareholders following this payment.

How does ONIVYDE fit into Ipsen’s overall growth strategy?

ONIVYDE is a key component of Ipsen’s growth platforms and new medicines, contributing to the company’s solid financial growth. Ipsen aims to achieve annual sales growth of at least 7% between 2023 and 2027, partly driven by ONIVYDE’s expanded use.

Sources

1. Ipsen delivers strong sales in the first quarter of 2024... - BioSpace
2. Merrimack Reports Full Year 2023 Financial Results - Stock Titan
3. Ipsen to Acquire Oncology Assets from Merrimack Pharmaceuticals - Business Wire
4. With FDA nod for Onivyde combo, Ipsen ends 10-year drought in... - Fierce Pharma