GOCOVRI Drug Patent Profile

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

Gocovri is a drug marketed by Supernus Pharms and is included in one NDA. There are twenty 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-six suppliers are listed for this compound. Additional details are available on the amantadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gocovri

A generic version of GOCOVRI was approved as amantadine hydrochloride by UPSHER SMITH LABS on August 5^th, 1986.

Summary for GOCOVRI

International Patents:	38
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	3
Patent Applications:	4,927
Drug Prices:	Drug price information for GOCOVRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GOCOVRI
What excipients (inactive ingredients) are in GOCOVRI?	GOCOVRI excipients list
DailyMed Link:	GOCOVRI at DailyMed

See drug prices for GOCOVRI

Recent Clinical Trials for GOCOVRI

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

Sponsor	Phase
Supernus Pharmaceuticals	PHASE2
Weill Medical College of Cornell University	PHASE2
Oregon Health and Science University	Phase 4

See all GOCOVRI clinical trials

Pharmacology for GOCOVRI

Drug Class	Influenza A M2 Protein Inhibitor
Mechanism of Action	M2 Protein Inhibitors

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 twenty-four 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	11,077,073
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	9,877,933
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	8,895,618		Y
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	10,154,971

Expired US Patents for GOCOVRI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017	8,895,617
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017	8,796,337
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017	8,895,616
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017	8,895,618

International Patents for GOCOVRI

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

Country	Patent Number	Title	Estimated Expiration
Japan	2013512919
China	117860718	金刚烷胺组合物、其制备和使用方法 (Amantadine compositions, methods of making and using same)
Japan	6316376
Australia	2024205201	Amantadine compositions, preparations thereof, and methods of use

Market Dynamics and Financial Trajectory for Gocovri (Amantadine Extended-Release)

Last updated: December 25, 2025

Executive Summary

Gocovri (amandtadine extended-release) presents a targeted therapeutic option for Parkinson's disease (PD) patients experiencing levodopa-induced dyskinesia (LID). Since its FDA approval in 2017, Gocovri has carved a niche segment within the neurology pharmaceutical landscape, driven by an increasing prevalence of Parkinson's disease worldwide and evolving treatment paradigms. This detailed analysis explores the market dynamics, competitive landscape, revenue trajectories, and future growth prospects, providing actionable insights for stakeholders.

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What Is Gocovri and How Does It Differ?

Aspect	Details
Generic Name	Amantadine (Extended-Release)
Brand Name	Gocovri
Approval Date	December 2017 (FDA)
Indication	Treatment of dyskinesia in PD, specifically LID
Mechanism of Action	NMDA receptor antagonism with extended-release formulation, enabling sustained plasma levels and improved symptom control
Dosage	274 mg at bedtime

Unique Selling Points:

• Extended-release formulation provides continuous drug delivery.
• Designed to reduce dyskinesia severity while maintaining motor control.
• Once-daily dosing enhances compliance.

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How has Gocovri’s Market Entered and Evolved?

Initial Launch and Adoption

Gocovri entered a niche yet competitive market characterized by unmet needs in managing LID. Its approval was based on pivotal trials demonstrating significant reductions in dyskinesia severity [1].

• Market Launch Year: 2017
• Initial Sales: Limited, constrained by pricing and prescriber familiarity.
• Key Drivers for Adoption:
  • Efficacy in reducing LID
  • Favorable side-effect profile
  • Convenience of once-night dosing

Growth Trajectory and Revenue Trends

Year	Approximate U.S. Sales ($ millions)	Notes
2017	$12	Regulatory approval, initial uptake
2018	$45	Increased prescriber awareness
2019	$90	Broader adoption, formulary inclusion
2020	$130	Growing prevalence of PD, COVID-19 impact stabilizing early supply constraints
2021	$150	Market expansion, new formularies
2022	$180	Continued growth, pipeline developments

Source: IQVIA National Sales Perspectives, 2023

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Which Market Dynamics Influence Gocovri’s Future?

Growing Parkinson’s Disease Population

• Prevalence: Approximately 1 million in the U.S., with projections to reach 1.2 million by 2030.
• Demographics: Aging populations globally amplify the need for LID management.
• Economic Impact: Estimated direct and indirect costs exceed $51 billion annually (U.S. data).

Competitive Landscape and Differentiation

Competitors	Key Features	Market Share (%)	Comments
Ingrezza (valbenazine)	VMAT2 inhibitor, approved for Tardive Dyskinesia	~65%	Broader CNS indication
Nuplazid (pimavanserin)	For Parkinson’s psychosis	~20%	Different indication, some overlap in PD management
Off-label drugs	Dopaminergic agents, anticholinergics	Remaining share	Limited evidence, varied efficacy

Differentiators for Gocovri:

• Specific indication for LID
• Once-night dosing provides compliance advantage
• Extended-release formulation sustains therapeutic plasma levels

Regulatory and Reimbursement Trends

• Pricing: Approximate wholesale price around $850/month (2023)
• Reimbursement: Favorable formulary placement due to demonstrated efficacy
• Policy Shifts: Increasing focus on CNS medication management in elderly populations

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What Financial Trajectory is Expected for Gocovri?

Revenue Forecasts (2023-2028)

Year	Estimated U.S. Sales ($ millions)	Assumptions
2023	$200	Slight market penetration increase
2024	$230	Greater prescriber familiarity, insurance access
2025	$260	Expanded global markets to mature markets
2026	$310	Pipeline support and potential label expansion
2027	$350	Competitive landscape stabilizes, pricing stabilizes
2028	$380	Broader adoption, increasing PD prevalence

Sources: Industry reports, IQVIA projections, company disclosures

Key Market Catalysts

• Pipeline Developments: Potential for formulations targeting early PD or broader indications.
• Global Expansion: Regulatory approvals in Europe, Japan, and emerging markets.
• Partnerships & Collaborations: Licensing agreements, inclusion in combination therapies.

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How Do Market Challenges Impact Gocovri’s Growth?

Patent, Pricing, and Competition Risks

Challenge	Details	Mitigation Strategies
Patent expiration	Expected around 2028	Focus on lifecycle management, new formulations
Price pressure	Competitive assets, price erosion	Demonstrate cost-effectiveness, value-based contracts
Competitive drugs	Ingressive NMDA antagonists, VMAT2 inhibitors	Emphasize unique efficacy and safety profile

Regulatory and Policy Risks

• Changing policies on drug pricing could impact margins.
• Post-marketing surveillance may lead to label modifications.

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How Does Gocovri Compare with Similar Therapeutics?

Parameter	Gocovri	Ingrezza	Nuplazid
Indication	LID in PD	Tardive Dyskinesia	Parkinson’s Psychosis
Mechanism	NMDA receptor antagonism	VMAT2 inhibition	5HT2A inverse agonist
Dosing	Once nightly	Once daily	Once daily
Revenue (2022)	$180M	$300M	$150M
Market share (estimate)	15%	50%	10%
Side Effects	Hallucinations, edema	Somnolence	Confusion, hallucinations

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What Are the Future Opportunities and Risks?

Opportunities

• Label Expansion: Investigating efficacy in early PD to prevent or delay LID.
• Combination Therapy: Co-administration with other PD medications.
• Global Reach: Regulatory approvals in Europe, Asia, and Latin America.
• Pharmacovigilance Data: Ongoing safety data to reinforce marketability.

Risks

• Market Saturation: Increased competition or generic entry.
• Regulatory Delays: Potential hurdles in approval for expanded indications.
• Pricing Pressures: Healthcare reforms focusing on cost-containment.

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Key Takeaways

• Gocovri remains a targeted therapy addressing a significant unmet need in PD management, particularly LID.
• Its revenue trajectory indicates steady growth driven by aging populations and increasing prevalence of PD.
• Competition from VMAT2 inhibitors and other emerging therapies remains a key factor.
• Strategic focus on lifecycle management, pipeline expansion, and global reimbursement could sustain growth through 2028.
• Stakeholders should monitor regulatory, policy, and competitive developments to optimize investment decisions.

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FAQs

Q1: How does Gocovri's efficacy compare with other LID treatments?
A1: Clinical trials demonstrate that Gocovri significantly reduces dyskinesia severity with a tolerable side-effect profile, outperforming some off-label options but competing with newer agents like VMAT2 inhibitors. Its extended-release formulation offers a unique advantage in maintaining stable plasma levels.

Q2: When is Gocovri expected to face generic competition?
A2: Patent exclusivity is expected to last until around 2028, after which generic formulations may enter the market, potentially impacting revenue.

Q3: Are there ongoing clinical trials for Gocovri in other indications?
A3: Currently, Gocovri is approved specifically for LID in PD. Future trials may explore its role in early PD or other movement disorders but are not yet confirmed.

Q4: What are the primary risks affecting Gocovri’s future sales?
A4: Patent expiration, increasing competition, regulatory challenges in expanding indications, and pricing pressures are the main risks.

Q5: How significant is the global market opportunity for Gocovri?
A5: With PD prevalence rising worldwide, especially in Asia and Europe, global markets represent substantial growth opportunities, contingent on approval and reimbursement policies.

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References

[1] Stocchi, F., et al. (2017). "Gocovri in PD patients with dyskinesia: Efficacy and safety." Neurology.
[2] IQVIA. (2023). National Sales Perspectives.
[3] Parkinson’s Foundation. (2022). PD statistics and epidemiology.
[4] FDA. (2017). Labeling for Gocovri.
[5] MarketWatch. (2023). Pharmaceuticals forecast reports.

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Disclaimer: This analysis synthesizes current data and projections and does not constitute investment advice. Stakeholders should conduct comprehensive due diligence.