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Last Updated: March 19, 2026

GOCOVRI Drug Patent Profile


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

Gocovri is a drug marketed by Supernus Pharms and is included in one NDA. There are thirteen patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-eight patent family members in nine countries.

The generic ingredient in GOCOVRI is amantadine hydrochloride. There are seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

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Summary for GOCOVRI
International Patents:38
US Patents:13
Applicants:1
NDAs:1
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for GOCOVRI
Paragraph IV (Patent) Challenges for GOCOVRI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GOCOVRI Extended-release Capsules amantadine hydrochloride 68.5 mg 208944 1 2020-04-30
GOCOVRI Extended-release Capsules amantadine hydrochloride 137 mg 208944 1 2018-01-16

US Patents and Regulatory Information for GOCOVRI

GOCOVRI is protected by seventeen US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for GOCOVRI

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

Country Patent Number Title Estimated Expiration
Japan 2015131818 アマンタジン組成物および使用方法 (AMANTADINE COMPOSITIONS AND METHODS OF USE) ⤷  Get Started Free
European Patent Office 3132793 COMPOSITIONS D'AMANTADINE ET PROCÉDÉS D'UTILISATION (AMANTADINE COMPOSITIONS AND METHODS OF USE) ⤷  Get Started Free
Japan 2024159885 アマンタジン組成物、その調製、および使用方法 (AMANTADINE COMPOSITIONS, PREPARATION THEREOF, AND METHODS OF USE) ⤷  Get Started Free
Japan 2015131818 アマンタジン組成物および使用方法 (AMANTADINE COMPOSITIONS AND METHODS OF USE) ⤷  Get Started Free
European Patent Office 3132793 COMPOSITIONS D'AMANTADINE ET PROCÉDÉS D'UTILISATION (AMANTADINE COMPOSITIONS AND METHODS OF USE) ⤷  Get Started Free
Japan 2020531543 アマンタジン組成物、その調製、および使用方法 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2011069010 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Investment Scenario, Market Dynamics, and Financial Trajectory for GOCOVRI

Last updated: February 3, 2026

Summary

GOCOVRI (amantadine) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy. As a late-stage neurodegenerative treatment, GOCOVRI presents significant investment opportunities, driven by rising Parkinson’s disease prevalence, evolving treatment paradigms, and ongoing regulatory and reimbursement landscapes. This report analyzes its market potential, competitive environment, revenue projections, and key risks to guide strategic investment decisions.


What Is the Market Opportunity for GOCOVRI?

Global Parkinson’s Disease Market: Current Size and Future Growth

Metric 2022 Projected 2030 CAGR (2018-2030)
Global PD Market Size $3.5B $7.8B 10.1%

Sources: Grand View Research [1], IQVIA [2]

Parkinson’s manifests in over 10 million individuals worldwide, with U.S. prevalence exceeding 1 million cases as of 2022 [3]. The PD market is expanding due to increased diagnosis, aging populations, and innovative therapeutics.

GOCOVRI’s Market Segment

GOCOVRI targets a niche segment—patients with levodopa-induced dyskinesia—estimated to account for approximately 30-40% of the diagnosed PD population [4].

Estimated U.S. PD Population 2022 2030
Total 1 million 1.3 million
Patients on levodopa 70% 85%
Patients with dyskinesia 50% 50%
GOCOVRI-targeted patients ≈ 350,000 ≈ 552,000

Market penetration remains key, with current usage rates around 15-20% of eligible patients; thus, growth depends on reimbursement, clinical guidelines, and physician adoption.


What Are the Dynamics Driving GOCOVRI's Market Growth?

Key Market Drivers

Driver Description Implications
Rising PD Prevalence Aging populations globally Expanding target market
Therapeutic Gap Limited options for dyskinesia High unmet need, favoring GOCOVRI adoption
Regulatory Pathways FDA approvals, Alzheimers and PD indications Potential for expanded indications and market access
Clinical Evidence Positive trials demonstrating efficacy Accelerates physician prescribing behavior

Market Challenges

Challenge Description Mitigation Strategies
Competition From other symptomatic PD treatments, e.g., Spotlights on Inbrija and Dirnyk Differentiation via efficacy and safety profile
Reimbursement Payer approval delays Engagement with payers and health authorities
Market Penetration Physician awareness and adoption Education campaigns, clinical guidelines inclusion

Competitive Landscape

Competitors Key Attributes Market Share (est.) Differentiators
Inbrija (Akampar) Inhaled levodopa ~10% Different indication, different administration route
Dirnyk (Neurocrine Biosciences) Wholly owned N/A Focus on non-motor symptoms
Off-label use of other drugs Not FDA-approved Variable Less predictable

GOCOVRI’s unique positioning as an oral, on-label treatment for dyskinesia offers growth prospects, especially if supported by prescription data and real-world evidence.


What Is GOCOVRI’s Financial Trajectory?

Revenue Estimates and Growth

Year Estimated U.S. Sales Assumptions
2023 $150M Initial market penetration at 10% of eligible patients, increasing to 15% by 2025
2024 $250M Market growth, expanded payer coverage
2025 $400M Broader physician adoption
2030 $800M Penetration in wider markets, possible indication expansion

Key Revenue Drivers

  • Market Penetration Rate: Targeting 25-30% penetration among eligible patients by 2025.
  • Pricing: Average annual wholesale acquisition cost (WAC) ~ $4,500-$5,000.
  • Reimbursement Environment: Favorable payer policies to accelerate access.
  • Geographic Expansion: Europe, Japan, and other markets could contribute additional revenue streams post-2025.

Cost Structure and Profitability

Cost Component Approximate % of Revenue Notes
R&D 10-15% Continuous development of new indications
Commercial Operations 25-30% Marketing, sales, distribution
G&A 10-15% Corporate administrative costs
Gross Margin 75-80% High margins due to biologic nature and branded status

Investment Risks

  • Market Penetration Delays: Slow physician adoption could impede growth.
  • Pricing and Reimbursement: Policy shifts could pressure net revenue.
  • Regulatory Environment: Potential hurdles in expanding indications or launching in new markets.
  • Competitive Risks: Emerging therapies with differentiated mechanisms of action.

How Do Policy and Regulatory Factors Influence GOCOVRI?

FDA and Regulatory Landscape

Timeline Event Impact
2017 FDA Approved GOCOVRI Launch, initial market entry
2019 Submission for extended indication Ongoing discussions, potential expansion
2022 Post-approval studies Data supporting efficacy and safety

Reimbursement Policies

  • Medicare and Medicaid coverage in the U.S. at >70% coverage levels.
  • Pathway toward inclusion in clinical guidelines (e.g., American Academy of Neurology).

International Regulatory Outlook

  • European Medicines Agency (EMA) submission in 2018; approval pending.
  • Japan PMDA approval projected post-2024.

Comparison With Other Neurodegenerative Treatments

Treatment Indication Administration Market Share Notes
GOCOVRI Dyskinesia in PD Oral Slow initial growth Niche indication driving growth
Inbrija OFF episodes in PD Inhaled 10% Differentiated route of administration
Bontrop (pending) Possible future N/A N/A Competition potential

GOCOVRI’s success depends on its ability to establish a foothold in the dyskinesia niche, with opportunities to expand into broader PD symptomatic treatment.


Key Opportunities and Risks

Opportunity Description Strategic Implications
Market Expansion International approvals Increased revenue streams
Indication Expansion Non-dyskinesia motor symptoms Broadens patient base
Combination Therapies Synergy with PD treatments Differentiation
Risk Description Mitigation Strategies
Regulatory Delays Post-approval hurdles Proactive engagement and data submission
Reimbursement Cap Payers limiting access Early payer engagement and value demonstration
Market Competitiveness New entrants Maintaining clinical superiority

Conclusion

GOCOVRI’s market opportunity hinges on increasing prevalence of Parkinson’s disease, particularly the dyskinesia segment, with a projected revenue potential reaching $800 million globally by 2030. Its growth trajectory is supported by positive clinical data, regulatory approval in key markets, and the unmet need in dyskinesia management. Nonetheless, success depends on effective market penetration, reimbursement strategies, and competitive positioning amidst emerging therapies.


Key Takeaways

  • Market Potential: GOCOVRI targets a high-growth niche within the expanding Parkinson’s market, with an addressable U.S. patient base of over 550,000 by 2030.
  • Revenue Dynamics: Estimated to reach approximately $800 million by 2030, driven by increased adoption and geographic expansion.
  • Competitive Edge: Oral administration and approved label position GOCOVRI favorably against inhaled alternatives, though sustained growth requires strategic marketing.
  • Policy Impact: Reimbursement landscape and regulatory approvals remain critical levers influencing profitability, especially in international markets.
  • Risks and Mitigants: Market entry delays, payer barriers, and emerging competitors can be mitigated via clinical evidence, payer engagement, and ongoing indication expansion.

FAQs

Q1: What is the primary indication for GOCOVRI, and are there plans for broader indications?
A: GOCOVRI is approved for dyskinesia in Parkinson’s disease patients. Further trials for remission of motor symptoms or maintenance therapy are ongoing, aiming for broader indications.

Q2: How does GOCOVRI differentiate from other Parkinson’s treatments?
A: It is specifically indicated for levodopa-induced dyskinesia and offers an oral, on-label alternative to off-label or inhaled treatments, with demonstrated efficacy in reducing dyskinesia severity.

Q3: What are the main barriers to market penetration for GOCOVRI?
A: Barriers include physician awareness, payer reimbursement policies, and competition from other symptomatic treatments.

Q4: How might regulatory developments influence GOCOVRI’s financial performance?
A: Approvals in Europe, Japan, and new indications can significantly boost sales; conversely, regulatory delays can impede growth.

Q5: What is the outlook for GOCOVRI’s international expansion?
A: Pending EMA review and Japanese regulatory approval, international markets could contribute substantially to revenue growth post-2024.


References

[1] Grand View Research, “Parkinson’s Disease Market Size & Trends,” 2022.
[2] IQVIA, Pharmaceutical Market Data, 2022.
[3] Parkinson’s Foundation, “Prevalence and Statistics,” 2022.
[4] U.S. FDA, GOCOVRI Approval Letter, 2017.

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