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	7,786,133		Y	Y
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes	7,786,133		Y	Y
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

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	7,662,365
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	7,056,500
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014	8,067,431
Averitas	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014	7,662,365

International Patents for naloxegol oxalate

Country	Patent Number	Title	Estimated Expiration
South Korea	20060126714	PEGYLATED SMALL MOLECULES
Eurasian Patent Organization	018427	ХИМИЧЕСКИ МОДИФИЦИРОВАННЫЙ НАЛОКСОН (CHEMICALLY MODIFIED NALOXONE)
South Africa	200605763	Pegylated small molecules
Hungary	E026726
Mexico	2013003587
Netherlands	300737

Supplementary Protection Certificates for naloxegol oxalate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	C 2015 022	Romania		PRODUCT NAME: NALOXEGOL SI SARURILE SALE ACCEPTABILE FARMACEUTIC, IN SPECIAL SAREA OXALAT A NALOXEGOLULUI; NATIONAL AUTHORISATION NUMBER: EU/1/14/962; DATE OF NATIONAL AUTHORISATION: 20141208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/962; DATE OF FIRST AUTHORISATION IN EEA: 20141208
1694363	300737	Netherlands		PRODUCT NAME: NALOXEGOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NALOGEXOLOXALAAT; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363	122015000037	Germany		PRODUCT NAME: NALOXEGOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION 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
1694363	CR 2015 00028	Denmark		PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 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

Naloxegol oxalate Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Naloxegol Oxalate?

Naloxegol oxalate, marketed as Movantik, is a peripherally acting mu-opioid receptor antagonist developed by AstraZeneca. It treats opioid-induced constipation (OIC), primarily in opioid therapy patients with cancers or chronic pain. As opioid use remains prevalent, demand for specialized treatments like naloxegol oxalate persists.

Market Size and Growth

The global opioid-induced constipation market was valued at approximately USD 2.2 billion in 2022. Compound annual growth rate (CAGR) projections estimate a 4.8% increase through 2028. Naloxegol's contribution is significant within this sector, driven by rising opioid prescriptions.

The primary drivers include:

• Increasing opioid utilization for pain management, especially in cancer and chronic non-cancer pain.
• Awareness of adverse effects from long-term opioid use, leading clinicians to adopt targeted therapies.
• Expansion into markets outside the US, notably Europe and Asia, where opioid prescriptions are rising.

Competitive Landscape

The drug faces competition from:

• Methylnaltrexone (Relistor by Salix/Biogen): Older drug, initially launched in 2008.
• Naloxone formulations: Used as rescue therapies.
• Newer oral agents: Such as naldemedine (Symproic), approved in 2017, with a similar mechanism.

Market share is influenced by efficacy, safety profiles, dosing convenience, and regulatory approvals. Movantik's once-daily oral formulation supports its adoption.

Regulatory Environment

FDA approval for Movantik occurred in 2014. Key considerations include:

• Label updates reflecting safety data, particularly regarding GI perforations.
• Lynigemol's performance in post-approval studies influences market stability.
• Increasing regulatory scrutiny of opioids and related drugs.

Pricing Trends

Average wholesale price (AWP) for naloxegol is approximately USD 400 per month. Payer dynamics impact access, with barriers stemming from:

• Cost-effectiveness debates relative to older therapies.
• Coverage limitations by insurance plans, especially in managed care.

Patent and Market Exclusivity

AstraZeneca holds patents extending into 2027. Patent challenges or generic entrants could reduce pricing and market share after that period.

What Is the Financial Trajectory for Naloxegol Oxalate?

The financial outlook hinges on sales volume, pricing, and market penetration.

Revenue Estimates

• In 2022, Movantik generated roughly USD 220 million in global sales.
• Growth rates are projected at 4-6% annually, consistent with market expansion.

Investment and R&D Costs

• Development costs for Movantik reportedly exceeded USD 1 billion, factoring in clinical trials and regulatory approval.
• Ongoing investments target formulations improvements and expansion into new indications, potentially enhancing sales.

Cost of Goods Sold (COGS)

• Estimated at 20% of revenue, factoring in manufacturing and distribution costs.
• Economies of scale could reduce COGS as sales increase.

Profitability Margins

• Operating margins hover around 30-35%, influenced by marketing expenses, patent life, and competition.
• Patent expiration post-2027 may pressure margins unless new formulations or indications emerge.

Market Risks

• Entry of generics post-2027 could dilute revenue streams.
• Shifts in opioid prescribing practices or regulatory restrictions could decline demand.
• Competitive response through new therapies may impede market share growth.

How Do Market Dynamics and Financials Interact?

Market growth sustains revenue, but remains susceptible to regulatory, competitive, and pricing pressures. Patent expiry introduces potential revenue decline, which can be mitigated through pipeline expansion, such as investigational uses or combination therapies.

Investments in clinical trials and new formulations could extend patent life or create new revenue streams, influencing long-term financial trajectory.

Key Takeaways

• The opioid-induced constipation market is growing annually, supporting demand for naloxegol oxalate.
• Current global sales are around USD 220 million, with moderate growth projections.
• Competitive landscape includes older drugs like methylnaltrexone and newer agents like naldemedine.
• Patent protection lasts until approximately 2027; generics are imminent.
• Financial margins are stable but face decline post-patent expiration without pipeline innovations.
• Regulatory and market access barriers influence pricing, impacting profitability.

FAQs

1. When does naloxegol oxalate patent expiry occur?
Patent protection extends through 2027, after which generic competitors may enter the market.

2. What are the primary competitors to naloxegol oxalate?
Methylnaltrexone (Relistor) and naldemedine (Symproic) are leading alternatives within the OIC treatment space.

3. How does opioid prescribing trend affect naloxegol markets?
Rising opioid use increases demand, but regulatory measures reducing opioid prescriptions could decrease the need for adjunct therapies.

4. What is the patient adoption rate for naloxegol?
Approximate adoption accounts for a significant segment of opioid-treated patients with constipation; detailed figures are proprietary but reflect steady growth since 2014.

5. Are there pipeline products or indications for naloxegol?
Research into additional uses and formulations is ongoing, with potential to extend product lifecycle beyond current patents.

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Sources:

1. MarketWatch, "Opioid-Induced Constipation Market Size," 2022.
2. AstraZeneca Annual Report 2022.
3. FDA Label for Movantik (naloxegol oxalate).
4. EvaluatePharma, "Pharmaceutical Market Trends," 2023.
5. IQVIA, "Prescription Data," 2022.