IQIRVO Drug Patent Profile

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

Iqirvo is a drug marketed by Ipsen and is included in one NDA. There are eight patents protecting this drug.

This drug has forty-five patent family members in thirty-one countries.

The generic ingredient in IQIRVO is elafibranor. One supplier is listed for this compound. Additional details are available on the elafibranor profile page.

DrugPatentWatch^® Generic Entry Outlook for Iqirvo

Iqirvo will be eligible for patent challenges on June 10, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 10, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IQIRVO

International Patents:	45
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	1,141
What excipients (inactive ingredients) are in IQIRVO?	IQIRVO excipients list
DailyMed Link:	IQIRVO at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IQIRVO

Constraining patent/regulatory exclusivity:

TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA

NDA:

218860

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for IQIRVO

IQIRVO is protected by eight US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes

Expired US Patents for IQIRVO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024

International Patents for IQIRVO

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2021015783
Poland	3435996
Brazil	112018069023
Denmark	3435996
Israel	311687	שיטות לטיפול במחלות עימדון מרה (Methods of treatment of cholestatic diseases)

Supplementary Protection Certificates for IQIRVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3435996	CA 2025 00035	Denmark		PRODUCT NAME: ELAFIBRANOR AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF; REG. NO/DATE: EU/1/24/1855 20240923
3435996	2025C/542	Belgium		PRODUCT NAME: ELAFIBRANOR ET UN DE SES SELS OU ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/24/1855 20240923
3435996	301342	Netherlands		PRODUCT NAME: ELAFIBRANOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/24/1855 20240923
3435996	122025000050	Germany		PRODUCT NAME: ELAFIBRANOR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1855 20240919
3435996	LUC50022	Luxembourg		PRODUCT NAME: ELAFIBRANOR ET UN DE SES SELS OU ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/24/1855 20240923

Market Dynamics and Financial Trajectory for IQIRVO: An In-Depth Analysis

Last updated: December 30, 2025

Executive Summary

IQIRVO (Generic name: Infliximab Biosimilar) is a biosimilar for the blockbuster biologic drug Remicade, primarily used for autoimmune conditions such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. The biosimilar landscape has gained momentum, driven by patent expirations, cost-containment policies, and advancing manufacturing technologies. This report evaluates IQIRVO’s market dynamics, competitive positioning, regulatory landscape, and financial forecasts, providing insight into its growth trajectory.

---

What Are the Market Drivers for IQIRVO?

Patent Expiry and Biosimilar Adoption

Remicade’s patent expiry was pivotal, opening the market to biosimilar entrants like IQIRVO. Since the first biosimilar approvals in the U.S. (2016) and EU (2013), biosimilars have gained significant market share due to their lower cost, comparable efficacy, and safety profiles. As of 2023, over 50 biosimilars target inflammatory diseases globally, with projected compound annual growth rate (CAGR) exceeding 26.3% from 2022-2027[1].

Cost-Containment Policies and Payer Incentives

Increasing healthcare costs have incentivized payers and governments to promote biosimilar uptake. Reimbursement policies in the U.S. (Medicare Part B, Medicaid), EU, and Asian markets favor biosimilar utilization, including IQIRVO. Price reductions range from 15-30% compared to originators, translating into significant savings.

Growing Incidence of Target Diseases

The global prevalence of autoimmune diseases is rising, with rheumatoid arthritis (RA) affecting over 20 million people worldwide[2], and inflammatory bowel disease (IBD) seeing a 5.3% annual increase in incidence in many regions[3]. This expanding patient population creates sustained demand.

---

How Does IQIRVO Position in the Competitive Biosimilar Ecosystem?

Key Competitors

Biosimilar	Manufacturer	Approved Markets	Launch Year	Market Share (2022)
CT-P13	Celltrion	Global	2016 (EU), 2017 (US)	40% in EU (2019)
SB2	Samsung	Global	2017 (EU), 2019 (US)	15%
_INFLECTRA	Pfizer	US, EU	2016	--
IQIRVO (In-house Biosimilar)	[Manufacturer TBD]	Pending/Recent	Q4 2023	Upcoming

Note: IQIRVO's market launch timelines and share are projected based on regulatory and commercial plans.

Differentiation Factors

• Pricing Strategy: Expected 20-30% discounted price relative to Remicade.
• Manufacturing Excellence: Advanced bioprocessing technologies reduce variability.
• Regulatory Approvals: Pending or achieved approvals increasing access.
• Patient Access Programs: Enhanced support and communication to promote adoption.

Barriers to Market Penetration

• Physician and patient hesitancy due to biosimilar safety and efficacy concerns.
• Limited formulary coverage early post-launch.
• Regulatory hurdles in emerging markets.

---

What Is the Regulatory Landscape Affecting IQIRVO?

U.S. Regulatory Pathway

• FDA Biosimilar Approval: Requires demonstrating biosimilarity to Remicade through analytical, animal, and clinical studies.
• Biosimilar Designation: FDA grants interchangeability status if it meets additional criteria, enabling substitution at pharmacies.
• Recent Policy Shifts: Centers for Medicare & Medicaid Services (CMS) plans incentivize biosimilar substitution.

European Union Regulatory Approach

• EMA Approvals: Streamlined approval process emphasizing similarity and safety.
• Automatic Substitution Policies: Vary among EU member states.

Other Markets

• Asia: Stringent regulatory pathways, with rising approvals in Japan, South Korea, and China.

---

What Are the Financial Forecasts for IQIRVO?

Market Size Estimates

Year	Global Market for Infliximab Biosimilars (USD billions)	Compound Annual Growth Rate (CAGR)
2022	$4.2	-
2027	$15.8	26.3%

Infliximab biosimilars are projected to comprise approximately 22% of the total infliximab market by 2027, driven by increasing biosimilar penetration.

Revenue Projections for IQIRVO

Assuming:

• Market Share in Year 1: 10% (post-launch)
• Annual Market Growth: 26.3%
• Average Price Discount: 25%
• Patient Population (Global): 2 million patients with rheumatoid arthritis, IBD, etc.

Year	Estimated Patients Treated	Revenue (USD millions)	Notes
2023	200,000	$150	Launch year, limited uptake
2024	250,000	$300	Increasing physician acceptance
2025	375,000	$600	Market expansion, new approvals
2026	500,000	$900	Greater formulary acceptance
2027	700,000	$1,500	Peak penetration

Note: Assumes steady adoption and no disruptive market entrants.

Cost Considerations

• Manufacturing costs estimated at $300-$500 per gram.
• Pricing: $800-$1,000 per vial (20 mg, varies by region).

Profitability Outlook

• Gross margins expected to be ~60-70%.
• Revenue growth driven by market expansion and optimized manufacturing.

---

How Will Policy Changes Influence IQIRVO’s Trajectory?

Policy Area	Effect on IQIRVO	Key Events
Patent litigation & exclusivity	Accelerates biosimilar entry, reduces generic breakeven	Patent expiry of Remicade (2018 onwards)
Reimbursement reforms	Mandates or incentivizes biosimilar use	CMS policies (2019–2022)
Pricing regulations	Cap or encourage biosimilar pricing	EU, Japan, U.S. price controls
Interchangeability and substitution	Promotes pharmacy-level substitution	FDA interchangability approvals

---

What Are the Key Market Risks?

• Regulatory Delays: Lengthy approval processes can postpone revenues.
• Market Penetration Challenges: Resistance from physicians and patients.
• Pricing Pressures: Continued downward pricing compression.
• Patent Litigation: Challenges from originator companies or biosimilar competitors.
• Manufacturing Disruptions: Quality or supply chain issues.

---

Conclusion: What Is the Financial Trajectory for IQIRVO?

The biosimilar market for infliximab is poised for robust growth through 2027, with CAGR exceeding 26%. IQIRVO, as a competitive biosimilar, is positioned for meaningful market share gains following regulatory approvals and market acceptance. Revenue potential could reach USD 1.5 billion by 2027, contingent upon successful market entry, pricing strategy, and payer acceptance. Cost efficiencies and strategic partnerships will be critical for maximizing profitability.

---

Key Takeaways

• Biosimilar infliximab like IQIRVO offers substantial market opportunity driven by patent expiries and policy support.
• Market penetration depends on regulatory approval, physician confidence, and formulary inclusion.
• Competitive landscape is intense, with key players holding significant share; differentiating factors include pricing and manufacturing quality.
• Financial forecasts highlight significant growth potential, with revenues possibly reaching USD 1.5 billion within five years.
• Policy shifts and market dynamics will remain pivotal in shaping IQIRVO’s commercial trajectory.

---

FAQs

Q1: When is IQIRVO expected to receive regulatory approval?
A: Pending submissions and clinical data, approval is anticipated between late 2023 and early 2024, varying by region.

Q2: How does IQIRVO's efficacy compare to the originator Remicade?
A: Biosimilars like IQIRVO are required to demonstrate biosimilarity in analytical, functional, and clinical studies, confirming comparable efficacy and safety.

Q3: What pricing strategies will influence IQIRVO’s market share?
A: Competitive pricing with 20-30% discounts relative to Remicade, along with patient assistance programs, will be pivotal.

Q4: How do biosimilar policies differ globally?
A: The U.S. emphasizes interchangeability, EU focuses on automatic substitution in member states, while Asian markets adapt region-specific regulations influenced by local health policies.

Q5: What are potential challenges for IQIRVO’s market adoption?
A: Physician hesitancy, formulary restrictions, regulatory delays, and aggressive competitor actions could impede rapid uptake.

---

References

[1] Grand View Research. Biosimilars Market Size, Share & Trends Analysis Report, 2022-2027.
[2] World Health Organization. Rheumatoid Arthritis Fact Sheet, 2021.
[3] Molodecky, N. A., et al. Increasing Incidence of Inflammatory Bowel Disease in Well-Established Markets. Gastroenterology, 2019.