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 seventy-one patent family members in thirty-two countries.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Fifteen 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:	171
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	36
Patent Applications:	4,821
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	PHASE1
National Health Research Institutes, Taiwan	PHASE1
Kaohsiung Medical University Chung-Ho Memorial Hospital	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
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
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

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
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
Australia	2016340153
Australia	2022203167
Brazil	112018006922
Brazil	122021024957
Canada	3001467

Supplementary Protection Certificates for ONIVYDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	300885	Netherlands		PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: 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	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	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

Onivyde (irinotecan liposome) Market Dynamics and Financial Trajectory

Last updated: April 22, 2026

What is Onivyde’s market position by line of therapy and geography?

Onivyde is a branded formulation of irinotecan in a liposomal delivery vehicle. In the US, Onivyde is marketed by Servier and is tied to metastatic disease settings where it is used in combination regimens. In practice, Onivyde’s addressable market is driven by:

• US adoption in metastatic pancreatic cancer where it is incorporated into standard-of-care sequences.
• Geographic reimbursement dynamics (coverage, prior authorization friction, formulary placement) that directly impact quarterly prescription volume.
• Treatment line mix: Onivyde demand tracks how quickly patients reach later-line settings and how quickly clinicians adopt it after guideline updates.

Market-facing demand drivers (observable through payer behavior and purchasing patterns)

1. On-label patient identification: patient eligibility criteria (tumor stage, performance status, prior therapy) constrain near-term volume.
2. Combination regimen usage: uptake correlates with clinic standardization of combination protocols rather than mono-therapy use.
3. Competing irinotecan strategies: competition is less about “same API” alone and more about relative convenience, toxicity management, and payer preference.

How do competitive dynamics influence pricing power and share?

Onivyde faces competition from:

• Other cytotoxic backbones in metastatic pancreatic cancer (including guideline-relevant regimens that compete for the same line of therapy).
• Alternative irinotecan administration strategies (including off-protocol use patterns and local practice variation).
• Biosimilar and small-molecule erosion pressures in broader oncology formularies, where payers increasingly push towards lower-cost alternatives where clinical value is perceived as comparable.

Competitive impact levers

• Formulary tier placement: once a payer moves a competing regimen to a preferred tier, Onivyde volume can shift without changing overall incidence.
• Restricted access: prior authorization and step edits can reduce conversion from eligible prescriptions to filled prescriptions.
• Hospital procurement behavior: oncology pharmacies and group purchasing organizations influence net price through contract rebates.

What are the key financial trajectory benchmarks for Onivyde?

Onivyde’s financial trajectory is determined by:

• Net sales growth or contraction as adoption matures and as payer restrictions tighten or loosen.
• Gross-to-net pressures from rebates, contract payments, and channel mix.
• Cost and margin structure tied to manufacturing scale, supply chain performance, and contract terms.

Revenue trend structure (how analysts model Onivyde’s quarter-to-quarter)

Onivyde’s quarterly results generally decompose into:

• Unit volume (patient starts, prescriptions, infusion events)
• Net price (list price minus rebates/discounts)
• Mix shift (different sites of care and regimen usage)

In mature branded oncology products, unit volume is typically the primary swing factor during uptake phases, while net price becomes the swing factor during payer tightening.

What does the product lifecycle imply about medium-term sales pressure?

Onivyde is a branded product in oncology; as the market matures, financial trajectory tends to shift from adoption-driven growth toward:

• Competitive displacement in a subset of patients
• Formulary compression that increases rebate intensity
• Denial management costs that reduce effective conversion

For an investor or R&D planner, the key question is whether Onivyde’s volume growth can outpace net price erosion. In late-stage oncology brands, that balance is usually decided by:

• Whether guideline usage expands into additional subpopulations or combinations, and
• Whether payers view Onivyde as differentiated enough to preserve access.

How do regulatory and label changes translate into commercial outcomes?

For branded oncology products, the label-to-sales transmission path typically runs through:

1. Guideline and payer recognition of labeled indications
2. Clinical pathway integration (how quickly sites standardize infusion protocols)
3. Real-world uptake (time lag between label availability and prescribing behavior)

For Onivyde, the commercial impact of any label expansion depends on whether it creates:

• A new population segment that is both clinically eligible and administratively reimbursable, or
• A shift in line-of-therapy placement that changes how often patients encounter Onivyde in care pathways.

What are the most decision-relevant market dynamics to watch going forward?

Demand-side signals

• Patient starts and refill cadence in treated cohorts (proxy for persistence and regimen standardization)
• Site of care mix (community vs hospital oncology pharmacy purchasing)
• Clinical guideline inertia (time to adoption after evidence updates)

Payer and pricing signals

• Contract coverage breadth across major payers (net coverage rate)
• Rebate pressure intensity (net price trajectory vs list price)
• Prior authorization tightening (denial rates and approvals)

Competitive signals

• Switching behavior from Onivyde to other regimens at comparable lines
• Consolidation of regimen standards in large oncology networks

What financial trajectory should business and investment teams expect under base-case dynamics?

Without introducing assumptions about specific future quarters, the expected trajectory pattern for a mature, branded oncology infusion product like Onivyde typically follows:

• Moderate growth or stabilization when clinician adoption is steady and access remains broad.
• Net price compression over time as payers leverage increasing formulary alternatives and contract renegotiations.
• Volume volatility around guideline shifts, competitive launches, and payer policy changes.

In practice, the “tell” is whether volume keeps growing as net price declines. When volume stabilizes but net price erodes, sales usually plateau. When both move in opposite directions, sales growth can re-accelerate.

Where does Onivyde sit versus key competitors on commercial levers?

Onivyde’s differentiators in commercial planning usually include:

• Clinical protocol fit in metastatic pancreatic cancer pathways
• Administration convenience relative to complex multi-step regimens, where applicable
• Tolerability profile implications that influence regimen selection

Competitors can offset these with:

• Lower acquisition cost
• Preferred formulary positioning
• More favorable contracting economics

Key Takeaways

• Onivyde’s market outcome is driven by later-line metastatic pancreatic cancer demand, formulary access, and regimen standardization in oncology practices.
• Competitive dynamics shape sales through payer tiering, prior authorization friction, and rebate intensity, not just product-level efficacy.
• Financial trajectory is best modeled from unit volume (patient starts) plus net price (gross-to-net pressures); in mature brands, net price erosion typically becomes the dominant downside risk.
• Label and guideline changes translate into sales only after payer recognition and site-level protocol adoption.

FAQs

1) What determines Onivyde demand most strongly?
Patient access to metastatic pancreatic cancer treatment pathways and whether payers allow Onivyde without restrictive authorization.

2) What moves Onivyde sales quarter-to-quarter?
Unit volume (patient starts and infusion events) and net price (rebates, discounts, contract terms).

3) How does competition affect Onivyde without direct “same drug” rivalry?
Oncology formularies choose preferred regimens by access and net economics, which can shift treatment selection even when alternatives share overlapping mechanisms.

4) Why do label expansions not always produce immediate revenue growth?
Commercial impact requires payer coverage decisions and clinician pathway adoption, which can lag.

5) What should be monitored for early signs of sales pressure?
Formulary restriction, increased denials, and worsening net price trends that outpace any volume growth.

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References

[1] Servier. Onivyde (irinotecan liposome injection) product information and prescribing information.
[2] U.S. Food and Drug Administration (FDA). Onivyde (irinotecan liposome) label and approval documents.
[3] FDA. Drug Trials Snapshots for Onivyde (irinotecan liposome).
[4] National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Pancreatic Adenocarcinoma (relevant sections for irinotecan liposome regimens).

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