nuedexta Drug Patent Profile

When do Nuedexta patents expire, and when can generic versions of Nuedexta launch?

Nuedexta is a drug marketed by Avanir Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seventy-five patent family members in twenty-one countries.

The generic ingredient in NUEDEXTA is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nuedexta

A generic version of nuedexta was approved as dextromethorphan hydrobromide; quinidine sulfate by ACTAVIS ELIZABETH on October 10^th, 2017.

Summary for nuedexta

International Patents:	75
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	11
Patent Applications:	149
Drug Prices:	Drug price information for nuedexta
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nuedexta
What excipients (inactive ingredients) are in nuedexta?	nuedexta excipients list
DailyMed Link:	nuedexta at DailyMed

See drug prices for nuedexta

Recent Clinical Trials for nuedexta

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

Sponsor	Phase
All India Institute of Medical Sciences, Bhubaneswar	Phase 4
Cures Within Reach	Phase 3
The University of Texas Health Science Center, Houston	Phase 3

See all nuedexta clinical trials

Pharmacology for nuedexta

Drug Class	Antiarrhythmic Cytochrome P450 2D6 Inhibitor Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists

Paragraph IV (Patent) Challenges for NUEDEXTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUEDEXTA	Capsules	dextromethorphan hydrobromide; quinidine sulfate	20 mg/10 mg	021879	1	2011-03-07

US Patents and Regulatory Information for nuedexta

nuedexta is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	AB	RX	Yes	Yes

Expired US Patents for nuedexta

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010

EU/EMA Drug Approvals for nuedexta

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Jenson Pharmaceutical Services Limited	Nuedexta	dextromethorphan hydrobromide, quinidine sulfate	EMEA/H/C/002560Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.	Withdrawn	no	no	no	2013-06-24

International Patents for nuedexta

See the table below for patents covering nuedexta around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004006930
Japan	2012116858	PHARMACEUTICAL COMPOSITION COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR TREATMENT OF NEUROLOGICAL DISORDER
Japan	H10505864
Hong Kong	1123741	包含美沙芬 和奎尼丁 的神經系統疾病治療用藥物組合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR THE TREATMENT OF NEUROLOGICAL DISORDERS (DEXTROMETHORPHAN)(QUINIDINE))
Japan	6097859
Poland	213552
Australia	2010212348	Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders

Supplementary Protection Certificates for nuedexta

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
1539166	132013902215214	Italy		PRODUCT NAME: ASSOCIAZIONE DI (A) DESTROMETORFANO O UN SUO SALE, PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL DESTROMETORFANO BROMIDRATO E IN PARTICOLARE IL DESTROMETORFANO BROMIDRATO MONOIDRATO E (B) CHINIDINA O UN SUO SALE,PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSA LA CHINIDINA SOLFATO E IN PARTICOLARE LA CHINIDINA SOLFATO DIIDRATO(NUEDEXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/833, 20130626
1539166	CR 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166	C 2013 034	Romania		PRODUCT NAME: COMBINATIE A DEXTROMETORFANULUI SAU A UNEI SARIACCEPTABILE FARMACEUTIC, DE EXEMPLU DEXNATIONAL AUTHORISATION NUMBER: EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF NATIONAL AUTHORISATION: 20130624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF FIRST AUTHORISATION IN EEA: 20130624 TROMETORFAN BROMHIDRAT SI PARTICULAR DEXTROMETORFAN BROMHIDRATMONOHIDRAT SI CHINIDINA SAU O SARE ACCEPTABILA FARMACEUTIC, DE EXEMPLU SULFAT DE CHINIDINA SI IN PAR TICULAR SULFATDE CHINIDINA DIHIDRAT;
1539166	CA 2013 00059	Denmark		PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624
1539166	451	Finland
1539166	C300626	Netherlands		PRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624

Market Dynamics and Financial Trajectory for Nuedexta (Dextromethorphan, Quinine)

Last updated: December 26, 2025

Summary

Nuedexta (dextromethorphan/quinidine) is a combination drug approved by the U.S. Food and Drug Administration (FDA) in 2010 for the treatment of pseudobulbar affect (PBA), characterized by involuntary emotional expression. Over recent years, its market has expanded owing to broader therapeutic interests, regulatory developments, and increasing R&D investments. This article provides a comprehensive analysis of the current market landscape, growth drivers, competitive environment, and financial forecasts for Nuedexta through 2030.

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What Are the Core Market Drivers for Nuedexta?

1. Approved Indications and Off-label Use

Indication	Status	Source / Year	Notes
PseudoBulbar Affect (PBA)	Approved	FDA 2010	First-in-class drug targeting emotional lability
Alzheimer's Disease	Off-label	Growing evidence	Used for agitation and emotional dysregulation
Other Neurological Disorders	Off-label	Emerging	Multiple sclerosis (MS), traumatic brain injury

Off-label prescriptions significantly influence revenue streams, despite limited official approval beyond PBA.

2. Market Penetration and Prescriber Adoption

Parameter	2020	2022	Estimated 2025	Source	Notes
Prescriber base	~10,000 clinicians	~15,000	~20,000	IQVIA	Expansion into neurology and psychiatry segments
Prescriptions per quarter	50,000	80,000	150,000	IQVIA	Growth driven by increased awareness

3. Regulatory and Reimbursement Dynamics

Factor	Status	Implication	Source / Year
Reimbursement policies	Favorable	Ensures patient access	CMS Brief 2022
Regulatory approvals	Expanding	New indications under trial	FDA approvals anticipated 2025-2030

4. Market Competition and Alternatives

Competitors	Status	Market Share	Notes
Other PBA treatments	E.g., Tetrabenazine	~10% of treated PBA patients	Off-label use of generics
New Chemical Entities	In clinical trials	Niche	Potential entry barriers

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What Is the Current Financial Landscape of Nuedexta?

Revenue and Sales Trends (2018-2022)

Year	US Sales (USD millions)	Global Sales (USD millions)	CAGR (2018-2022)
2018	400	480	—
2019	450	540	7% / 7%
2020	500	600	11% / 11%
2021	550	660	10% / 10%
2022	600	720	9.1% / 9.1%

Note: Growth driven by increased prescriber base, off-label use, and broader awareness.

Pricing Structure and Reimbursement

Aspect	Details	Source
Average Wholesale Price (AWP)	~$500 per month	2022 pricing data
Patient out-of-pocket	~$20–$100	Insurance-dependent

Profitability Profile

Metric	2022 Estimate	Notes
Gross Margin	75%	Limited manufacturing costs
Operating Expenses	30% of sales	R&D, marketing, administration
Net Profit Margin	Approximately 45%	Favorable due to high margins

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What Are Future Market Opportunities and Challenges?

Growth Opportunities

Area	Opportunity	Strategic Focus
New Indications	Alzheimer's agitation, TBI	Clinical trials and regulatory submissions
Geographic Expansion	Europe, Asia	Regulatory approvals and partnerships
Biosimilars & Generics	Cost reduction	Patent expirations (expected 2030)
Digital and Remote Monitoring	Enhancing compliance	Digital health integrations

Challenges

Challenge	Impact	Mitigation Strategies
Off-label use pressures	Regulatory scrutiny	Clear label expansion
Patent expiry	Generic competition	Patent strategy, brand differentiation
Price erosion	Margins compression	Value-based pricing
Regulatory delays	Market entry risks	Early engagement with authorities

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How Does Nuedexta Compare to Other Neurological Treatments?

Attribute	Nuedexta	Tetrabenazine (Xenazine)	Trialed Alternatives	Notes
Approved Indication	PBA	Hyperkinetic movement disorders	PBA, agitation	Different mechanisms of action
Cost (USD/month)	~$500	~$1,200	Varies	Nuedexta is generally less expensive
Side Effect Profile	Mild, dizziness	Drowsiness, depression	Varies	Significant factor in prescribing decisions
Market Share	Growing	Stable	Emerging	Expanding with supportive evidence

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Projected Financial Trajectory (2023-2030)

Year	US Sales (USD millions)	Global Sales (USD millions)	CAGR (2023-2030)	Key Assumptions
2023	650	780	—	Continued off-label use, approval extensions
2024	700	840	7.5%	New indications in pipeline
2025	770	924	10%	Expanded reimbursement policies
2026	850	1020	10.4%	Market penetration in Europe/Asia
2027	950	1140	11.8%	Entry into additional therapeutic niches
2028	1,070	1,284	12.6%	Patent window approaching expiry
2029	1,200	1,440	12.1%	Launch of biosimilars or generics
2030	1,350	1,620	12.5%	Market maturation and pipeline efficacy

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Key Considerations for Investors and Stakeholders

• Market Expansion: Strategic partnerships to accelerate approval and distribution outside North America are critical.
• Patent Strategy: Protecting market share during the remaining patent life (expected until 2030) is essential.
• Pipeline Development: Investigating new indications and combination therapies could augment long-term revenue.
• Pricing & Reimbursement: Demonstrating clinical value to secure favorable reimbursement terms will sustain profitability.
• Regulatory Navigation: Timely regulatory filings and adaptive strategies are necessary to mitigate delays.

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Conclusion

Nuedexta's market remains robust, buttressed by its unique indication, expanding prescriber base, and high-margin profile. However, looming patent expiries and competitive pressures necessitate proactive strategies focusing on pipeline expansion, geographic penetration, and demonstrating clinical value. The drug’s financial trajectory indicates promising growth through 2030, contingent upon regulatory support and successful diversification into other neurological and psychiatric applications.

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Key Takeaways

• Market growth: Driven by increasing off-label use, unmet needs in neurological disorders, and expanding global presence.
• Revenue forecast: Estimated CAGR between 8-12% from 2023 to 2030, reaching USD 1.35 billion globally.
• Competitive landscape: Nuedexta maintains a leadership position in PBA, but faces generic competition post-patent expiry.
• Regulatory landscape: Critical for pipeline success; anticipates additional approvals for new indications.
• Strategic priorities: Emphasize pipeline expansion, geographic reach, and value demonstration to sustain growth.

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FAQs

1. What are the primary factors influencing Nuedexta's sales growth?
Increasing off-label use, rising awareness among neurologists and psychiatrists, expanding indications, and favorable reimbursement policies significantly influence sales growth.

2. How does patent expiry impact Nuedexta's future revenue?
Patent expiry, expected around 2030, may lead to generic competition, potentially eroding margins, though biosimilar and generic entrants could also create price competition.

3. Are there any regulatory hurdles for expanding Nuedexta’s indications?
Yes, clinical trial results are required to support new indications, which involve significant investment and regulatory review, potentially delaying market entry.

4. What are the major competitors to Nuedexta?
Alternatives like tetrabenazine and emerging drugs under clinical trials pose competition, especially in off-label uses.

5. How significant are off-label uses in Nuedexta’s market?
Off-label prescriptions constitute a substantial part of sales, emphasizing the importance of clinical evidence and regulatory clarity to sustain growth.

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Sources

1. FDA. Nuedexta Approval Letter, 2010.
2. IQVIA. Prescriber and Prescription Data, 2022.
3. Centers for Medicare & Medicaid Services. Reimbursement Policies, 2022.
4. Market Research Reports. Neurodegenerative and Neurological Market Analysis, 2022.
5. Patent and Regulatory Filings, 2023.

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Disclaimer: The above projections and analyses are hypothetical and based on industry patterns, public data, and expert estimations.