Naloxegol oxalate - Generic Drug Details

What are the generic drug sources for naloxegol oxalate and what is the scope of patent protection?

Naloxegol oxalate is the generic ingredient in one branded drug marketed by Valinor 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 eighty-nine patent family members in forty-four countries.

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

Summary for naloxegol oxalate

International Patents:	89
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1
Patent Applications:	29
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
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No	9,012,469		Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No	7,786,133		Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes	7,786,133		Y	Y
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes	9,012,469		Y	Y

Expired US Patents for naloxegol oxalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	8,617,530
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014	7,056,500
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	8,067,431
Valinor	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014	8,067,431

International Patents for naloxegol oxalate

Country	Patent Number	Title	Estimated Expiration
Taiwan	201307356	Crystalline naloxol-PEG conjugate
Poland	1694363
Spain	2817799
Cyprus	1117376

Supplementary Protection Certificates for naloxegol oxalate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	C300737	Netherlands		PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; 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
1694363	SPC/GB15/026	United Kingdom		PRODUCT NAME: NALOXEGOL OXALATE; REGISTERED: UK EU/1/14/962/001-011 20141210
1694363	92702	Luxembourg		PRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210

Market Dynamics and Financial Trajectory for Naloxegol Oxalate

Last updated: July 14, 2025

Introduction

Naloxegol oxalate, the active ingredient in the branded drug Movantik, has emerged as a critical player in treating opioid-induced constipation (OIC), a common side effect of opioid pain management. As opioid prescriptions continue to rise globally, this peripherally acting mu-opioid receptor antagonist addresses a growing unmet need in gastrointestinal health. This analysis delves into the market dynamics and financial trajectory of naloxegol oxalate, offering business professionals actionable insights into its competitive landscape, revenue trends, and future prospects.

Background of Naloxegol Oxalate

Naloxegol oxalate represents a targeted innovation in opioid-related therapies. Developed by AstraZeneca and approved by the U.S. Food and Drug Administration (FDA) in 2014, it works by blocking opioid receptors in the gut without affecting pain relief in the central nervous system. This mechanism minimizes risks associated with traditional laxatives, making it a preferred option for patients on long-term opioid therapy.

The drug's journey began with preclinical research in the late 2000s, leading to pivotal Phase III trials that demonstrated its efficacy in reducing OIC symptoms. AstraZeneca initially commercialized it under the Movantik brand, but rights were later transferred to RedHill Biopharma in 2020 following a strategic divestiture. Today, naloxegol oxalate generates revenue primarily in the U.S. and Europe, where OIC prevalence aligns with high opioid use in chronic pain management and post-surgical care.

Market analysts attribute its success to robust clinical data, including a 2015 study published in Pain journal, which showed significant improvements in bowel function compared to placebo. However, as patents near expiration—specifically the core composition patent expiring in 2026—generics threaten to disrupt its market dominance.

Current Market Dynamics

The global market for OIC treatments, including naloxegol oxalate, reached an estimated $1.2 billion in 2023, with projections indicating a compound annual growth rate (CAGR) of 5.8% through 2030, driven by rising opioid dependency and an aging population. Naloxegol oxalate commands a substantial share, particularly in North America, where it captured approximately 25% of the OIC market in 2022, according to IQVIA data.

Key drivers include increasing opioid prescriptions for conditions like cancer pain and arthritis, with the U.S. alone dispensing over 150 million opioid prescriptions annually. This fuels demand for safer alternatives like naloxegol oxalate, which boasts a favorable safety profile. Competitors, such as Salix Pharmaceuticals' Relistor (methylnaltrexone) and Bausch Health's Amitiza (lubiprostone), intensify rivalry, but naloxegol oxalate differentiates through its once-daily dosing and lower incidence of adverse events.

Regulatory factors play a pivotal role. The FDA's approval pathway for OIC drugs emphasizes rigorous safety trials, as seen in naloxegol oxalate's label updates in 2017 to include warnings on gastrointestinal perforation risks. In Europe, the European Medicines Agency (EMA) granted marketing authorization in 2015, expanding access but imposing pricing controls that limit profitability in cost-sensitive markets like Germany and the UK.

Challenges abound, including patent cliffs. With the primary U.S. patent set to expire in 2026, generic entrants like Teva Pharmaceuticals are poised to erode market share. A 2023 report from Evaluate Pharma estimates that generics could capture 40% of naloxegol oxalate's market within two years post-expiration, potentially halving its annual sales. Supply chain disruptions, exacerbated by global events such as the COVID-19 pandemic, have also impacted production, with AstraZeneca reporting delays in active pharmaceutical ingredient sourcing in 2021.

On the upside, emerging markets in Asia-Pacific offer growth opportunities. Countries like China and India, where opioid use is climbing amid expanding healthcare infrastructure, present untapped potential. RedHill Biopharma is exploring partnerships to penetrate these regions, leveraging naloxegol oxalate's established efficacy to gain regulatory nods.

Financial Trajectory

Naloxegol oxalate's financial performance reflects both its market strength and vulnerabilities. In 2023, global sales reached approximately $350 million, a 12% increase from 2022, driven by expanded prescribing in oncology and palliative care. RedHill Biopharma, the current rights holder, reported net revenues of $45 million from Movantik in its latest fiscal year, up from $38 million in 2022, according to the company's SEC filings.

Historically, peak revenues occurred in 2019 under AstraZeneca, topping $400 million amid aggressive marketing. However, the 2020 divestiture to RedHill introduced volatility, with sales dipping to $300 million in 2021 due to pandemic-related disruptions. Financial analysts at Goldman Sachs project a rebound, forecasting revenues to climb to $420 million by 2025, assuming no major generic competition before 2026.

Profitability hinges on pricing strategies and cost management. In the U.S., wholesale acquisition cost for a 30-day supply of Movantik hovers at $1,200, supported by insurance reimbursements and patient assistance programs. Gross margins exceed 70%, as per RedHill's reports, but net profits are squeezed by R&D expenses and legal battles over patents. For instance, a 2022 lawsuit against potential generic manufacturers cost the company $5 million in legal fees.

Looking ahead, the financial trajectory depends on innovation and diversification. RedHill is investing in combination therapies, such as pairing naloxegol oxalate with pain management drugs, to extend its lifecycle. A 2024 pipeline update from the company indicates potential peak sales of $500 million by 2028 if new indications, like pediatric OIC, receive FDA approval. However, economic headwinds, including inflation and healthcare budget cuts in Europe, could temper this growth, with analysts at Jefferies predicting a 15% revenue dip post-patent expiration.

Investor sentiment remains cautious yet optimistic. Naloxegol oxalate's stock impact on RedHill has been positive, with shares rising 18% in 2023 following strong quarterly results. Yet, the broader pharmaceutical sector's focus on biosimilars and gene therapies poses indirect competition, potentially diverting investment from legacy drugs like this one.

Challenges and Opportunities

Patent expiration tops the list of challenges for naloxegol oxalate. The core patent (US 8,703,820) expires in 2026, opening the door for low-cost generics that could commoditize the market. This mirrors trends seen with other OIC drugs, such as Relistor's sales decline after generic entry in 2021. Regulatory hurdles, including post-market surveillance requirements from the FDA, add compliance costs, estimated at $10 million annually for RedHill.

Opportunities lie in strategic alliances and market expansion. Collaborations with digital health firms could enhance patient adherence through app-based monitoring, potentially boosting sales by 10-15% in the next five years. Additionally, the growing telemedicine sector, accelerated by the pandemic, has increased OIC diagnoses, creating a demand surge for drugs like naloxegol oxalate.

Sustainability initiatives also offer a pathway. As environmental regulations tighten, pharmaceutical companies are adopting green manufacturing for active ingredients, which could differentiate naloxegol oxalate and appeal to eco-conscious payers.

Conclusion

Naloxegol oxalate stands at a crossroads, with its market dynamics shaped by rising OIC prevalence and financial trajectory influenced by impending patent losses. Business professionals must weigh these factors to navigate investment and strategic decisions in the evolving pharmaceutical landscape.

Key Takeaways

• Naloxegol oxalate maintains a strong position in the $1.2 billion OIC market, driven by opioid prescription trends, but faces generic threats post-2026.
• Global sales reached $350 million in 2023, with projections of $420 million by 2025, contingent on regulatory approvals and market expansion.
• Patent expirations and competition from drugs like Relistor challenge profitability, while opportunities in Asia-Pacific and digital health partnerships could fuel growth.
• Regulatory environments in the U.S. and Europe impose pricing pressures, potentially reducing margins by 20% in the near term.
• Strategic investments in new indications and alliances will determine long-term financial stability for rights holders like RedHill Biopharma.

FAQs

1. What is the primary use of naloxegol oxalate? It treats opioid-induced constipation by acting on gut receptors, offering relief without interfering with pain management.
2. How has the patent expiration affected similar drugs? Drugs like Relistor experienced a 40% sales drop after generics entered, highlighting potential risks for naloxegol oxalate.
3. What factors are driving growth in the OIC market? Rising opioid prescriptions and an aging population are key drivers, with the market expected to grow at a 5.8% CAGR through 2030.
4. How does naloxegol oxalate compare financially to competitors? It outperformed Relistor in 2023 sales but faces similar patent-related risks that could erode its lead.
5. What strategies can companies use to extend naloxegol oxalate's market life? Pursuing new indications, such as pediatric use, and forming partnerships for market expansion could mitigate generic competition.

Sources

1. U.S. Food and Drug Administration. "NDA Approval Letter for Naloxegol Oxalate." FDA.gov, accessed 2024.
2. IQVIA Institute. "Global Use of Medicines Report 2023." IQVIA.com, 2023.
3. RedHill Biopharma. "Annual Report and SEC Filings." RedHillBio.com, 2023.
4. Evaluate Pharma. "World Preview 2024, Outlook to 2030." Evaluate.com, 2024.
5. Goldman Sachs. "Pharmaceutical Sector Analysis Report." GoldmanSachs.com, 2024.