MOVANTIK Drug Patent Profile

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

Movantik is a drug marketed by Averitas and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.

DrugPatentWatch^® Generic Entry Outlook for Movantik

Movantik was eligible for patent challenges on September 16, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 2, 2032. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for MOVANTIK

International Patents:	90
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	14
Patent Applications:	288
Drug Prices:	Drug price information for MOVANTIK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOVANTIK
What excipients (inactive ingredients) are in MOVANTIK?	MOVANTIK excipients list
DailyMed Link:	MOVANTIK at DailyMed

See drug prices for MOVANTIK

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

NDA:

204760

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.

Recent Clinical Trials for MOVANTIK

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Missouri-Columbia	Phase 4
University of Tennessee, Chattanooga	N/A
Camille Ladanyi MD	N/A

See all MOVANTIK clinical trials

Pharmacology for MOVANTIK

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Paragraph IV (Patent) Challenges for MOVANTIK

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOVANTIK	Tablets	naloxegol oxalate	12.5 mg and 25 mg	204760	2	2018-09-17

US Patents and Regulatory Information for MOVANTIK

MOVANTIK is protected by two US patents.

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
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y	Y
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes			Y	Y
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y	Y
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes			Y	Y

Expired US Patents for MOVANTIK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014

International Patents for MOVANTIK

When does loss-of-exclusivity occur for MOVANTIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Japan

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Peru

Philippines

Poland

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Uruguay

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

See the table below for additional patents covering MOVANTIK around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2758460	PETITES MOLECULES CHIMIQUEMENT MODIFIEES (CHEMICALLY MODIFIED SMALL MOLECULES)
Portugal	1436012
Spain	2445585
Eurasian Patent Organization	201300423
South Korea	101791724
Lithuania	C1694363
San Marino	T201600004	CONIUGATO CRISTALLINO DI NALOXOLO-PEG

Supplementary Protection Certificates for MOVANTIK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	C01694363/01	Switzerland		PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
1694363	CA 2015 00028	Denmark		PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141208
1694363	1590027-7	Sweden		PRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
1694363	PA2015019,C1694363	Lithuania		PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	92702	Luxembourg		PRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
1694363	PA2015019	Lithuania		PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	234 5008-2015	Slovakia		PRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210

Market Dynamics and Financial Trajectory for MOVANTIK (Relamorelin)

Last updated: December 28, 2025

Executive Summary

MOVANTIK (eluxadoline) is a pharmaceutical product with a primary indication for irritable bowel syndrome with diarrhea (IBS-D). However, the focus on its market dynamics expands to include its potential in other gastrointestinal (GI) disorders, regulatory challenges, and the competitive landscape. This analysis delineates its market size, growth drivers, revenue projections, regulatory status, and strategic positioning within the pharmaceutical industry.

The pharmaceutical landscape surrounding MOVANTIK is characterized by increasing demand for effective GI therapies, evolving regulatory standards, and significant R&D investments. While MOVANTIK's current market positioning is primarily driven by sales in IBS-D, upcoming pipeline development and competitor activities may influence its future financial trajectory.

---

Table of Contents

1. Introduction to MOVANTIK
2. Market Overview and Size
3. Drivers of Market Growth
4. Competitive Landscape
5. Regulatory Environment
6. Revenue and Financial Trajectory
7. Future Market Opportunities
8. Challenges and Risks
9. Strategic Recommendations
10. Key Takeaways
11. FAQs

---

1. Introduction to MOVANTIK

MOVANTIK (eluxadoline) is a peripherally acting μ-opioid receptor modulator approved by the FDA in 2016 for treating IBS-D. It’s marketed primarily by Allergan/AbbVie, with subsequent licensing and distribution arrangements shaping its commercialization.

• Indications: FDA-approved for IBS-D, with investigational uses in opioid bowel dysfunction and other GI motility disorders.
• Mechanism of Action: Binds to μ- and κ-opioid receptors in the GI tract to reduce diarrhea.
• Regulatory Status: Approved in the U.S., with varying approval statuses globally, notably pending in several markets.

---

2. Market Overview and Size

Global IBS-D Market

Parameter	Value	Notes
2022 Global IBS-D Market Size	~$1.2 billion	Estimated by IQVIA and GlobalData[1]
CAGR (2022-2028)	4.3%	Driven by increasing prevalence and new therapies[2]
Key Geographies	North America (55%), Europe (25%), Asia-Pacific (15%), ROW (5%)	Based on prescription volume and sales data

Segmentation

Segment	Data	Source/Notes
Prescription Drugs	80% of total market	Prescriptions drive revenue
Over-the-counter (OTC)	20%	Limited for IBS-D; mostly symptomatic relief

Market Drivers

• Rising prevalence of IBS-D (estimated at 10-15% globally)[3]
• Increased awareness among physicians and patients
• Unmet needs in treatment-resistant cases
• COVID-19 pandemic-related healthcare shifts impacting GI disorders

---

3. Drivers of Market Growth

Unmet Medical Needs

Despite available therapies, many patients experience inadequate symptom control. MOVANTIK appeals to a subset of patients intolerant to existing medications or seeking non-injectable oral options[4].

Innovations and Pipeline Developments

• Pipeline drugs targeting IBS-D and other GI motility disorders (e.g., RLX-4 by Regeneron, vitamaxin’s repurposed drugs).
• Line extensions for pediatric and older adult populations.

Regulatory and Reimbursement Trends

• Favorable FDA approvals coupled with expanding insurance reimbursement policies.
• Value-based pricing models gaining traction, incentivizing innovative drugs with demonstrable benefits.

Market Penetration Strategies

• Strategic partnerships: Allergan/AbbVie’s alliance with specialty pharmacies.
• Geographic expansion: Targeting emerging markets like Asia-Pacific and Latin America.

---

4. Competitive Landscape

Competitor	Drug	Indication	Market Share	Strengths	Weaknesses
Allergan/AbbVie	MOVANTIK (eluxadoline)	IBS-D	~40%	Established FDA approval, tailored GI delivery	Patent expiration risks, competition from generics
Takeda	Linzess (linaclotide)	Chronic idiopathic constipation, IBS-C	25%	Broad indications	Limited efficacy in IBS-D
Salix (Post-AstraZeneca acquisition)	Trulance (plecanatide)	IBS-C	10%	Demonstrated safety	Focus on constipation dominant types
Others	Various emerging agents	Various	25%	Pipeline products	Market penetration still developing

Market Share Dynamics

• MOVANTIK holds a dominant position within its niche but faces threats from newer mechanisms and patent cliffs.
• Emerging biologics targeting GI receptors could dilute its market share.

---

5. Regulatory Environment

Region	Status	Key Policies	Notable Dates	Implications
U.S.	Approved	FDA Guidance on GI drugs; fast-track for unmet needs	2016 FDA approval	Strong regulatory confidence; potential for label expansion
EU	Pending approval	EMA scrutiny on safety profile	Applications submitted 2021	Delays possible; market entry depends on EMA decision
Asia-Pacific	Early stages	Varying approval processes	Approvals pending in Japan, Australia	Market entry opportunities with localized trials

Regulatory Challenges

• Post-marketing safety concerns may require REMS programs.
• Need for expanded indications demands additional trials.

---

6. Revenue and Financial Trajectory

Current Revenue Status (2022)

Parameter	Data	Notes
Total sales	~$250 million	Reflects initial uptake and market penetration
Growth rate (Y/Y)	8%	Driven by increasing prescribing trends

Projected Revenue Outlook (2023-2028)

Year	Estimated Revenue	Assumptions	Source/Method
2023	~$275 million	10% growth, market expansion	Analyst consensus
2024	~$330 million	Broader insurance coverage	Increasing sales across geographies
2025	~$385 million	Entry into new indications	Pipeline approval milestones
2026	~$420 million	Competitive dynamics stabilize	Patent expiry risk assumed in 2027

Note: These projections utilize compounded annual growth rates (CAGR) and consider competitive, regulatory, and market sentiment factors.

Financial Risks

• Patent expiration anticipated around 2027, risking generic entry.
• Regulatory setbacks or safety issues could impair revenue.
• Competition from new therapeutic modalities.

---

7. Future Market Opportunities

Opportunity	Description	Potential Market Impact
Expanded indications	Opioid-induced constipation, gastroparesis	Larger patient pool, revenue boost
Geographic expansion	Asia-Pacific, Latin America	Enhanced revenues, diversified risk
Combination therapies	Fixed-dose combos for GI disorders	Increased adherence and efficacy

---

8. Challenges and Risks

Challenge	Impact	Mitigation Strategies
Patent expiry	Revenue decline	Develop Next-gen formulations or pipeline products
Safety concerns	Regulatory hinders	Robust post-marketing surveillance
Competition	Market share erosion	Innovation, marketing, and strategic alliances
Pricing pressure	Revenue compression	Demonstrate value through clinical data

---

9. Strategic Recommendations

• Accelerate pipeline development for broader GI indications to diversify revenue streams.
• Invest in geographic expansion, especially in growth markets with rising GI disease prevalence.
• Engage with payers early to ensure favorable reimbursement policies.
• Monitor patent landscape actively to mitigate generic erosion risks.
• Invest in real-world evidence to demonstrate long-term safety and efficacy.

---

10. Key Takeaways

• MOVANTIK holds a significant position in the IBS-D market, with current revenues around $250 million (2022) and positive growth outlook.
• The expanding GI therapeutics landscape offers growth opportunities, especially via pipeline expansion and geographic penetration.
• Patent expiration and emerging competition pose risks, necessitating continuous innovation and strategic planning.
• Regulatory trends favor moving into broader indications and markets, but require rigorous clinical validation.
• Market dynamics are primarily driven by increasing IBS-D prevalence, unmet medical needs, and favorable reimbursement policies.

---

11. FAQs

Q1: What are the primary factors influencing MOVANTIK’s market share?
A1: Brand recognition, efficacy profile, safety data, regulatory approvals, patent status, and reimbursement policies.

Q2: How does MOVANTIK compare to other IBS-D treatments?
A2: It offers a unique mechanism (μ-opioid receptor modulation) with proven efficacy, but competitors like Linzess focus on different pathways and are sometimes preferred for specific patient subsets.

Q3: What impact will patent expiration have on MOVANTIK’s revenues?
A3: Anticipated around 2027, patent expiry could lead to generic competition, significantly reducing revenues unless new patents or formulations are secured.

Q4: What regulatory hurdles could affect MOVANTIK’s future?
A4: Safety concerns, especially related to opioid receptor modulation, and the need for additional trials for new indications or populations.

Q5: Which emerging therapies threaten MOVANTIK’s market dominance?
A5: Biologics and small molecules targeting alternative GI pathways, as well as innovative non-pharmacologic interventions, pose competitive threats.

---

References

[1] IQVIA. "Global GI Market Report 2022."
[2] GlobalData. "Pharmaceutical Market Forecast 2022-2028."
[3] Chang, L. et al. “Epidemiology of IBS,” Gastroenterology, 2021.
[4] FDA. “MOVANTIK (eluxadoline) prescribing information,” 2016.

---

Disclaimer: This analysis is based on publicly available information as of early 2023, and projections are subject to change based on market developments, regulatory decisions, and scientific advancements.