XADAGO Drug Patent Profile

When do Xadago patents expire, and what generic alternatives are available?

Xadago is a drug marketed by Mdd Us and is included in one NDA. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xadago

A generic version of XADAGO was approved as safinamide mesylate by PRINSTON INC on April 25^th, 2024.

Summary for XADAGO

International Patents:	97
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	5
Patent Applications:	1,258
Drug Prices:	Drug price information for XADAGO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XADAGO
What excipients (inactive ingredients) are in XADAGO?	XADAGO excipients list
DailyMed Link:	XADAGO at DailyMed

See drug prices for XADAGO

Recent Clinical Trials for XADAGO

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

Sponsor	Phase
Zambon SpA	Phase 2
Alain Kaelin	Phase 4
Clinical Trial Unit Ente Ospedaliero Cantonale	Phase 4

See all XADAGO clinical trials

Pharmacology for XADAGO

Drug Class	Monoamine Oxidase Type B Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Monoamine Oxidase-B Inhibitors

US Patents and Regulatory Information for XADAGO

XADAGO is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No	8,076,515		Y	Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes	8,278,485			Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	No	8,278,485			Y

International Patents for XADAGO

When does loss-of-exclusivity occur for XADAGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

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 XADAGO around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1613296
Japan	2013139446
Norway	335537

Supplementary Protection Certificates for XADAGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	241 50017-2015	Slovakia		PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226
1613296	CA 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID OG LEVOPODA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150224
1613296	132016000023012	Italy		PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XADAGO

Last updated: September 2, 2025

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Introduction

XADAGO (safinamide) is an oral medication approved by the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of Parkinson's disease (PD). As a selective monoamine oxidase B (MAO-B) inhibitor, XADAGO provides symptomatic relief by increasing dopaminergic activity, often used as an adjunct to levodopa therapy. Understanding its market dynamics and financial trajectory involves analyzing epidemiological trends, competitive landscape, regulatory environment, patent lifecycle, and commercialization strategies.

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Market Overview and Epidemiology

Parkinson’s disease affects approximately 1 million Americans and over 10 million globally, with prevalence expected to double by 2040 due to aging populations [1]. As the disease progresses, patients experience motor fluctuations, including "wearing-off" effects, creating consistent demand for adjunct therapies such as XADAGO.

Key Drivers:

• Aging Population: The expanding demographic of older adults augments the base of potential patients.
• Unmet Medical Needs: Persistent side effects and limited options for managing motor fluctuations sustain demand for adjunct therapies.
• Increased Diagnosis Rates: Enhanced awareness and diagnostic capabilities amplify the number of treated patients.

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Competitive Landscape

XADAGO operates within the niche of MAO-B inhibitors, competing primarily with:

• Selegiline (Eldepryl, Zelapar): Long-standing first-generation MAO-B inhibitor with established prescribing patterns.
• Rasagiline (Azilect): Often preferred for its once-daily dosing and potentially fewer dietary restrictions.
• Safinamide's Differentiators: Its dual mechanism (reversible MAO-B inhibition and modulation of glutamate release) offers potential symptomatic benefits, which may translate into preferential physician prescribing in specific cases.

Other avenues include dopamine agonists, COMT inhibitors, and emerging therapies, with the competitive pressure intensifying from newer agents and combination therapies.

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Regulatory and Patent Landscape

Regulatory Approvals: XADAGO’s approvals in the U.S., Europe, and other markets expanded its availability, although market access varies by region based on local regulatory and healthcare policies [2].

Patent Life and Exclusivity: The initial patent protections for safinamide began around its approval period; however, patent expirations are expected within the next 5-8 years, depending on jurisdiction. Patent expiry significantly influences pricing power and market share, opening doors for generics and biosimilars, thereby impacting revenue streams.

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Market Penetration and Adoption

Since its 2017 launch, XADAGO has experienced moderate market acceptance. Key factors influencing adoption include:

• Physician Familiarity: Preference for established agents like rasagiline and selegiline.
• Efficacy Perception: Data suggest comparable efficacy, with some studies indicating benefits in motor fluctuation management.
• Side-Effect Profile: Well-tolerated with minimal dietary restrictions, which remains a selling point.

Despite its advantages, limited direct comparative trials and conservative prescribing patterns contribute to a slower uptake than initially projected.

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Pricing Strategy and Revenue Generation

XADAGO’s pricing aligns with other specialty neurologic therapies, with wholesale acquisition costs (WAC) approximately in the range of $6-8 per capsule, translating to annual treatment costs of roughly $2,000-$3,000 per patient [3].

Pharmaceutical companies’ revenue forecast hinges on:

• Market Penetration Rates: Established through physician education and clinical evidence.
• Pricing Environment: Payer policies and formulary access influence out-of-pocket costs.
• Sales Volume: Driven by the number of diagnosed and treated patients.

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Financial Trajectory and Forecasts

Projected revenues for XADAGO are tempered by several factors:

• Market Penetration Challenges: Existing preferences for rasagiline and selegiline limit market share.
• Patent Cliff: Approaching patent expiration could accelerate generic competition, reducing prices and revenues.
• Pipeline and Line Extension: Potential combination formulations or new indications could provide future growth avenues, but none have been approved yet.

Forecast Outlook (Next 5 Years):
Analysts estimate a compound annual growth rate (CAGR) of approximately 3-5% in the developed markets, driven by incremental adoption, expanded insurance coverage, and regional expansions. However, revenues are vulnerable to patent expiries and market saturation.

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Emerging Market and Global Trends

Emerging markets, such as China and India, present significant growth opportunities due to expanding healthcare infrastructure, increasing PD diagnosis rates, and rising purchasing power. Local regulatory approval and market access strategies will crucially affect growth trajectories.

Global collaboration and licensing agreements can facilitate broader distribution, particularly in regions where the drug is not yet available.

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Impact of Future Innovations and Market Disruptors

Advances in gene therapy, neuroprotective agents, and alternative dopaminergic treatments could potentially reshape the Parkinson's therapy paradigm, impacting XADAGO’s future relevance.

Furthermore, the development of personalized medicine approaches might refine prescribing patterns, favoring specific patient subsets and altering revenue paths.

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Conclusion

XADAGO’s market dynamics are characterized by moderate growth prospects within a competitive and evolving Parkinson’s disease treatment landscape. The drug benefits from a unique dual mechanism and favorable tolerability, but faces challenges from entrenched competitors, patent expiry pressures, and the emergence of new therapies.

Successful commercialization and sustained revenues will depend on strategic market expansion, optimizing formulary access, and ongoing clinical evidence generation.

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Key Takeaways

• Competitive Edge: XADAGO’s dual mechanism and tolerability offer differentiation but face stiff competition from rasagiline and selegiline.
• Market Growth: Aging populations and increased PD diagnosis underpin future market expansion, especially in emerging markets.
• Revenue Outlook: Moderate growth probabilities due to saturation and patent considerations; revenues are susceptible to decline post-patent expiry.
• Strategic Focus: Emphasizing regional expansion, healthcare provider education, and potential line extensions can influence financial trajectory.
• Innovation Risks: Advances in PD therapeutics and gene therapies could diminish XADAGO’s market share.

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FAQs

1. What factors influence the market share of XADAGO in Parkinson’s disease treatment?
Physician prescribing habits, comparative efficacy and side-effect profiles, patent protections, pricing strategies, and formulary inclusion primarily influence market share.

2. How does patent expiration impact XADAGO’s financial performance?
Patent expirations typically open the market to generic formulations, significantly reducing prices and potentially decreasing revenues and profit margins.

3. Are there upcoming regulatory changes that could affect XADAGO’s market?
Regulatory shifts favoring generic entry, formulary reforms, or approval of new competing agents could influence market dynamics.

4. What opportunities exist for expanding the use of XADAGO beyond Parkinson’s disease?
Currently approved solely for PD, research exploring other neurodegenerative or neuropsychiatric indications could potentially unlock new revenues.

5. How might emerging therapies impact XADAGO's market position?
Innovations in neuroprotective treatments or gene therapies could reduce reliance on symptomatic drugs like XADAGO, shifting market share to novel approaches.

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References

[1] Parkinson’s Foundation. Parkinson’s Disease Statistics. 2022.
[2] U.S. Food and Drug Administration. XADAGO (safinamide) Approval Information. 2017.
[3] IQVIA. Medicine Expenditure and Pricing Data. 2022.