Naloxegol oxalate - Generic Drug Details

What are the generic drug sources for naloxegol oxalate and what is the scope of freedom to operate?

Naloxegol oxalate is the generic ingredient in one branded drug marketed by Averitas and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxegol oxalate has ninety patent family members in forty-five countries.

There are three drug master file entries for naloxegol oxalate. Two suppliers are listed for this compound.

Summary for naloxegol oxalate

International Patents:	90
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1
Patent Applications:	88
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naloxegol oxalate
What excipients (inactive ingredients) are in naloxegol oxalate?	naloxegol oxalate excipients list
DailyMed Link:	naloxegol oxalate at DailyMed

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

Constraining patent/regulatory exclusivity:

9,012,469

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 naloxegol oxalate

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

Sponsor	Phase
Institut Paoli-Calmettes	Phase 2

See all naloxegol oxalate clinical trials

Pharmacology for naloxegol oxalate

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for naloxegol oxalate

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for NALOXEGOL OXALATE

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 naloxegol oxalate

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	9,012,469		Y	Y
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes	9,012,469		Y	Y
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No	7,786,133		Y	Y
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes	7,786,133		Y	Y

Expired US Patents for naloxegol oxalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	8,617,530
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014	7,056,500
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	7,056,500
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014	8,617,530
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	7,662,365

International Patents for naloxegol oxalate

Country	Patent Number	Title	Estimated Expiration
New Zealand	594834	Method of preparing PEGylated protein molecules
New Zealand	609874
Taiwan	I518088
Eurasian Patent Organization	201000994	ХИМИЧЕСКИ МОДИФИЦИРОВАННЫЕ МАЛЫЕ МОЛЕКУЛЫ
Lithuania	C1694363

Supplementary Protection Certificates for naloxegol oxalate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	27/2015	Austria		PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	C300737	Netherlands		PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363	CR 2015 00028	Denmark		PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. 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	2015/024	Ireland		PRODUCT NAME: NALOXEGOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE OXALATE SALT OF THE ALPHA-EPIMER OF NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141208

Market Dynamics and Financial Trajectory for NaloXegol Oxalate

Last updated: July 30, 2025

Introduction

NaloXegol Oxalate, marketed under the brand name Movantik, is a peripherally acting mu-opioid receptor antagonist developed primarily for the treatment of opioid-induced constipation (OIC), a common and debilitating side effect of opioid therapy. Since its approval, the drug's market performance has been shaped by evolving regulatory landscapes, competitive offerings, and expanding indications. This detailed analysis examines the key market dynamics and project the financial trajectory of NaloXegol Oxalate within the current pharmaceutical environment.

Market Landscape for Opioid-Induced Constipation Treatments

The global prevalence of opioid use has surged, driven by increasing chronic pain management and palliative care demands. This escalation amplifies the incidence of OIC, which affects up to 40% of patients on chronic opioid therapy ([1]). Consequently, the market for OIC therapeutics has experienced notable growth, with both branded and generic options competing for dominance.

Drivers of Market Growth

• Rising Opioid Prescriptions: The U.S. alone reports over 240 million opioid prescriptions annually, intensifying the need for targeted treatments ([2]).
• Underserved Market Need: Conventional laxatives fail to address OIC's underlying pathophysiology, creating demand for specific antagonists like NaloXegol.
• Expansion of Approved Indications: Beyond constipation, ongoing research suggests potential in other gastrointestinal motility disorders, broadening therapeutic scope.
• Regulatory Approvals and Payer Acceptance: Movantik received FDA approval in 2014 for OIC in non-cancer patients, establishing it as a leading agent, with continued payer coverage enhancing market access ([3]).

Competitive Environment

NaloXegol faces competition from several drugs, notably:

• Relistor (methylnaltrexone): Administered via subcutaneous injection.
• Symproic (naloxegol): Similar mechanism-to-mechanism.
• Laxatives and Prosecretory Agents: Over-the-counter and prescription options with varying efficacy profiles.

However, NaloXegol's oral formulation offers a significant compliance advantage, underpinning its market position.

Market Dynamics

Regulatory Factors

Regulatory agencies, predominantly the FDA, have prioritized drugs addressing opioid-related adverse effects, influencing market inflows. The approval of generic versions post-patent expiry has intensified price competition, impacting pricing strategies and revenue streams.

Pharmacoeconomic and Payer Perspectives

Cost-effectiveness analysis, emphasizing reduced hospitalizations and improved quality of life, has favored NaloXegol among payers. This has facilitated broader formulary inclusion, elevating sales potential.

Patient Adherence and Physician Adoption

The oral route enhances adherence, a critical factor in chronic management. Physician awareness programs and guidelines increasingly recommend NaloXegol as the first-line pharmacotherapy for OIC in non-cancer patients.

Pricing Strategies

Pricing remains a delicate balance. Premium pricing strategies leverage the drug's efficacy and quick onset, while negotiations with payers and inclusion in combination therapy guidelines influence revenue streams.

Financial Trajectory

Historical Revenue Performance

Since its launch in 2014, NaloXegol generated a peak global sales revenue of approximately $250 million in 2016, with subsequent fluctuations due to patent challenges and market saturation ([4]). The patent expiry in key regions, notably the U.S., initiated price erosions and increased generic competition.

Current Market Position

Post-patent expiration, branded sales declined by an estimated 30% over the subsequent two years, with generic counterparts capturing approximately 60-70% of market share in mature markets. Despite this, the innovator maintains revenue through strategic pricing and expanding indications.

Future Revenue Projections

Analysts project a steady decline in branded sales, stabilizing at around $100 million globally over the next five years. Nonetheless, emerging markets and institutional adoption in Asia-Pacific and Europe offer new revenue avenues, potentially offsetting declines in mature markets.

Pipeline and Growth Opportunities

• New Formulations: Development of sustained-release forms could improve convenience and expand indications.
• Additional Indications: Investigations into other gastrointestinal motility disorders could generate new revenue streams.
• Combination Therapy: Integration with opioid formulations to mitigate OIC proactively may redefine treatment paradigms.

Risks Impacting Financial Success

Key risks include:

• Increased generic competition.
• Regulatory delays or rejections for new indications.
• Pricing pressures from payers.
• Shifts in clinical guidelines favoring alternative therapies.

Economic and Strategic Considerations

Pharmaceutical companies must adopt dynamic pricing strategies, expand indications, and enhance physician education to sustain profitability. Building strategic alliances and investing in pipeline candidates are pivotal to counteracting declining revenues from primary indications.

Conclusion

NaloXegol Oxalate remains a significant player within the OIC treatment landscape, bolstered by its oral delivery and targeted mechanism. However, patent expirations and competitive pressures necessitate adaptive strategies to ensure sustained financial viability. The drug's future hinges on expanding indications, optimizing pricing amidst reimbursement pressures, and capitalizing on emerging markets.

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Key Takeaways

• Market Growth Driven by Opioid Use: Rising opioid prescriptions continue to expand the OIC treatment market, benefitting drugs like NaloXegol.
• Patent Expiry Impacts Revenue: Generic competition has challenged the revenue trajectory, necessitating innovation and diversification strategies.
• Oral Formulation as an Advantage: Ease of administration supports patient adherence and market share retention.
• Expansion of Indications and Markets: Exploring additional therapeutic uses and entering emerging markets can bolster revenues.
• Strategic Positioning Essential: Maintaining a competitive edge requires adaptive pricing, pipeline development, and physician engagement.

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FAQs

1. What is the current patent status of NaloXegol Oxalate?
The primary patent protections for Movantik have expired in several regions, leading to increased generic competition and downward pressure on prices.

2. What are the main competitors to NaloXegol in treating OIC?
Relistor (methylnaltrexone), Symproic (naloxegol), and over-the-counter laxatives are key competitors, with Relistor offering injectable options and Symproic providing similar oral formulations.

3. How does NaloXegol compare in efficacy and safety?
Clinical studies demonstrate comparable efficacy to other OIC treatments with a favorable safety profile, primarily causing gastrointestinal side effects like abdominal pain and nausea.

4. What market expansion opportunities exist for NaloXegol?
Potential exists in pediatric populations, additional gastrointestinal indications, and pharmacoeconomic positioning in emerging markets.

5. How is payer coverage influencing NaloXegol’s sales?
Widespread payer acceptance facilitated by demonstrable cost-effectiveness and clinical benefits has contributed to broader formulary access, supporting sustained sales.

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Sources:
[1] Webster, L. R. (2016). Opioid-Induced Constipation: Challenges and Treatment Strategies. Pain Management.
[2] CDC. (2022). Opioid Prescriptions in the United States. Centers for Disease Control and Prevention.
[3] FDA. (2014). Approval of Movantik (Naloxegol) for Opioid-Induced Constipation.
[4] MarketResearch.com. (2022). Opioid-Induced Constipation Therapeutics Market Report.