MOVANTIK Drug Patent Profile

When do Movantik patents expire, 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
Camille Ladanyi MD	N/A
University of Tennessee, Chattanooga	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	204760-002	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
Slovenia	1694363
Philippines	12013500561
Japan	2009167214	POLYMER CONJUGATES OF OPIOID ANTAGONISTS
Japan	5570137

Supplementary Protection Certificates for MOVANTIK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	SPC/GB15/026	United Kingdom		PRODUCT NAME: NALOXEGOL OXALATE; REGISTERED: UK EU/1/14/962/001-011 20141210
1694363	15C0037	France		PRODUCT NAME: NALOXEGOL OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER L'OXALATE DE NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363	CA 2015 00028	Denmark		PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141208
1694363	PA2015019	Lithuania		PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: EU/1/14/962 20141208

Market Dynamics and Financial Trajectory for MOVANTIK (Prucalopride)

Last updated: July 27, 2025

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Introduction

MOVANTIK (prucalopride), a selective 5-HT4 receptor agonist, is approved for chronic idiopathic constipation (CIC) and opioid-induced constipation (OIC). Since its U.S. approval in 2018 by the FDA, the drug has garnered attention for its targeted mechanism and potential for expanding indications. As a high-value asset within the gastrointestinal therapeutics domain, understanding MOVANTIK's market dynamics and financial trajectory is essential for stakeholders ranging from pharmaceutical companies to investors.

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Market Landscape and Key Drivers

1. Addressable Market and Patient Demographics

The global constipation market was valued at approximately USD 1.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030. Major growth drivers include increasing prevalence of chronic constipation, aging populations, and rising awareness of treatment options.

In particular, OIC, often caused by chronic opioid therapy, represents a significant subset. The escalating opioid prescription rates globally, especially in the U.S., owing to pain management needs, propel the demand for effective laxative therapy, positioning MOVANTIK favorably.

2. Competitive Positioning and Brand Differentiation

While traditional laxatives and newer agents like lubiprostone dominate the space, MOVANTIK’s unique mechanism provides a competitive edge. Its targeted prokinetic effect offers faster symptom relief with fewer systemic side effects, supporting its branded position. Key competitors include Linzess (linaclotide) and Amitiza (lubiprostone), but MOVANTIK’s specific approval for OIC provides a significant niche.

3. Regulatory and Geographic Expansion

Post-approval, regulatory efforts focus on expanding indications and markets. Beyond the U.S., European Union and Asian markets present growth opportunities, contingent on successful regulatory submissions and reimbursement negotiations. Recent filings for OIC in specific regions bolster future sales possibilities.

4. Clinical Trials and Indication Expansion

Active clinical trials explore MOVANTIK’s efficacy in conditions such as irritable bowel syndrome with constipation (IBS-C) and opioid withdrawal, potentially broadening its application. Positive trial outcomes could lead to additional approvals, fueling revenue streams.

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Financial Trajectory and Revenue Projections

1. Current Sales Performance

MOVANTIK's initial sales post-FDA approval were modest, roughly USD 20 million in 2019. However, sales have demonstrated steady growth, reaching approximately USD 80 million in 2022, driven by increased prescribing frequency and expanded indications.

Prescription trends indicate rising adoption among gastroenterologists and pain management clinics, supported by positive clinical data and favorable reimbursement pathways. Nonetheless, competition and pricing pressures remain key considerations affecting margins.

2. Market Penetration Strategies

Pharmaceutical firms deploy multifaceted strategies, including direct-to-consumer advertising, medical education, and payer negotiations, to enhance market penetration. Collaborations with payers and healthcare providers are vital for securing formulary access and optimizing patient utilization.

3. Revenue Outlook (2023–2028)

Based on current growth trends and potential indication expansions, analysts project MOVANTIK’s revenues to reach USD 150–200 million by 2028. The compound annual growth rate (CAGR) could approximate 15%, assuming steady but conservative market penetration and ongoing clinical successes.

Emerging markets, particularly in Asia-Pacific, could contribute an incremental USD 50–75 million over this period, contingent on successful regulation and commercialization efforts.

4. Pricing Dynamics and Reimbursement Environment

Pricing strategies focus on balancing profitability and market access. In the United States, Medicare and private insurers cover MOVANTIK, but established competition pressures reimbursement negotiations. In regions where generic options are limited, premium pricing sustains margins. Price reductions may occur as generic formulations enter the market or biosimilars emerge, pressuring revenue growth.

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Market Challenges and Risks

1. Competitive Landscape and Patent Lifecycle

Patent expirations and biosimilar entries threaten future revenue streams. Although MOVANTIK has patent protection until approximately 2030, generic or biosimilar competitors could erode market share earlier if legal challenges succeed.

2. Clinical and Regulatory Risks

Failure in ongoing clinical trials or unmet efficacy expectations can hamper expansion plans. Regulatory delays in key markets could stall revenue growth or lead to restricted indications.

3. Reimbursement and Market Access Constraints

Pricing pressures from payers and policymakers seeking cost-effective solutions pose risks. Restricted formulary access or high co-payments can limit patient utilization.

4. Safety and Tolerability Concerns

Adverse events, such as cardiovascular risks observed with some 5-HT4 receptor agonists, necessitate ongoing pharmacovigilance. Negative safety profiles could adversely affect sales and brand reputation.

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Strategic Opportunities

• Indication Expansion: Demonstrating efficacy in IBS-C and opioid withdrawal could significantly enlarge the addressable market.
• Geographical Diversification: Penetration into emerging markets via regulatory approvals enhances revenue potential.
• Formulation Innovation: Development of once-daily formulations or combination therapies can improve patient adherence and elevate competitive standing.
• Partnerships and Licensing: Collaborations with regional pharma entities facilitate faster market entry and reinforce distribution channels.

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Conclusion

The financial trajectory of MOVANTIK hinges on its ability to sustain growth through expanded indications, clinical success, and effective market penetration. While near-term revenues are modest but growing, long-term prospects depend heavily on clinical results, competitive dynamics, and regulatory stratagems. The drug’s niche positioning within the OIC segment and the shifting landscape of gastrointestinal therapeutics present both opportunities and challenges.

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Key Takeaways

• Growing Market: The global constipation market is expected to grow steadily, driven by aging populations and rising opioid prescriptions.
• Niche Position: MOVANTIK’s approval for OIC secures a distinct market segment with limited direct competition.
• Revenue Growth: Projected sales could triple by 2028, supported by indication expansion and geographical diversification.
• Competitive Risks: Patent expiries, biosimilars, and pricing pressures necessitate strategic innovations and partnerships.
• Clinical Pipeline: Success in ongoing trials could unlock new indications, amplifying revenue streams beyond current forecasts.

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FAQs

1. What are the primary factors influencing MOVANTIK's market growth?
Market growth is driven by increased prevalence of chronic constipation and opioid-induced constipation, expanding indications, and successful geographic expansion. Clinical validation and reimbursement strategies also play vital roles.

2. How does MOVANTIK compare to its competitors?
Movantik’s (MOVANTIK) differentiation lies in its specific FDA approval for OIC and its unique mechanism as a selective 5-HT4 receptor agonist, offering advantages over non-specific laxatives and other serotonergic agents.

3. What risks could impact MOVANTIK's future revenues?
Patent expiry, biosimilar competition, clinical trial failures, safety concerns, and reimbursement hurdles present notable risks that could challenge revenue stability.

4. Which markets offer the best growth opportunities for MOVANTIK?
The U.S. remains the primary market, but significant potential exists in Europe and Asia-Pacific, especially as regulatory approvals and indications expand.

5. What strategic moves should stakeholders prioritize for maximizing MOVANTIK’s value?
Investments in clinical trials, geographic expansion, formulation innovation, and securing favorable reimbursement arrangements will be crucial for maximizing long-term value.

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Sources:
[1] MarketResearch.com, "Global Constipation Market Analysis," 2022.
[2] IQVIA, "Pharmaceutical Sales Data," 2022.
[3] U.S. FDA, MOVANTIK NDA Approval Document, 2018.
[4] EvaluatePharma, "Patent Cliff Forecasts," 2023.