GOCOVRI Drug Patent Profile

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 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-five 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
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	9,867,793
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes	8,895,616

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	208944-002	Aug 24, 2017	8,895,618
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	208944-001	Aug 24, 2017	8,796,337
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017	8,895,616
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017	8,796,337

International Patents for GOCOVRI

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

Country	Patent Number	Title	Estimated Expiration
Australia	2010325960
Canada	2782556	COMPOSITIONS D'AMANTADINE ET PROCEDES D'UTILISATION ASSOCIES (AMANTADINE COMPOSITIONS AND METHODS OF USE)
European Patent Office	2623099	Composition et procédé de traitement d'une maladie neurologique (Composition and method for treating neurological disease)
Japan	2013512919
Japan	6038203
World Intellectual Property Organization (WIPO)	2006058236

Market Dynamics and Financial Trajectory for GOCOVRI (Amantadine Extended-Release) in Parkinson’s Disease Management

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Introduction

GOCOVRI (amantadine extended-release) represents a significant advancement in the symptomatic management of Parkinson’s disease (PD), specifically targeting dyskinesia. Since its FDA approval in 2017, GOCOVRI has expanded the therapeutic landscape, influencing market dynamics through innovative formulation, competitive positioning, and evolving clinical demands. Analyzing its market trajectory entails understanding its clinical niche, competitive environment, regulatory landscape, and revenue forecasts.

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Pharmacological Profile and Clinical Positioning

GOCOVRI’s mechanism centers on sustained-release delivery of amantadine, an established PD management agent. Unlike immediate-release formulations, GOCOVRI offers prolonged therapeutic plasma concentrations, allowing once-daily dosing, primarily reducing levodopa-induced dyskinesia (LID). Its approval was based on clinical trials demonstrating significant reductions in dyskinesia severity, translating into improved quality of life for PD patients [1].

This precise targeting by GOCOVRI has cemented its status as a first-line adjunct therapy for dyskinesia, making it a key player in PD symptomatic management.

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Market Landscape and Competitive Dynamics

Prevalence and Market Penetration

Parkinson’s disease affects approximately 10 million globally, with neurodegenerative progression necessitating complex medication regimens. Dyskinesia impacts roughly 50% of PD patients after five years of levodopa therapy, underscoring a substantial market for symptomatic treatments like GOCOVRI [2].

Competitive Environment

GOCOVRI faces competition mainly from traditional immediate-release amantadine formulations, such as Symmetrel, and emerging therapies like tetrabenazine and deutetrabenazine for dyskinesia, alongside experimental agents (e.g., new dopaminergic modulators). However, GOCOVRI’s extended-release formulation offers distinct clinical benefits—improved compliance, stable plasma levels, and better symptom control—fostering its competitive edge.

Pricing and Reimbursement Dynamics

As a branded medication with a high-cost profile, GOCOVRI’s market expansion is influenced by payer reimbursement policies. In the U.S., Medicare and private insurers’ coverage decisions, utilization of formulary placement, and patient access programs critically impact its sales volume.

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Regulatory and Market Expansion

Global Regulatory Status

While GOCOVRI retains exclusive U.S. marketing rights (via Adamas Pharmaceuticals), international adoption hinges on regulatory approvals across key markets such as Europe, Canada, and Asia. Limited regulatory approvals outside the U.S. currently restrain global growth, although ongoing filings and clinical data submissions may catalyze international expansion.

Pipeline and Formulation Innovations

Derivative formulations or combination therapies integrating GOCOVRI’s technology could expand therapeutic indications, aligning with broader PD management strategies. Additionally, ongoing post-marketing studies examining long-term safety and efficacy underpin market confidence and potential label expansions.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Trends

Since its launch, GOCOVRI’s revenues have experienced steady growth, driven by increasing PD prevalence and rising awareness among clinicians. Data indicate revenues of approximately $70-100 million annually in the U.S., representing a moderate but consistent growth trajectory as the drug gains clinical adoption and formulary coverage improves [3].

Growth Drivers

1. Increased Patient Adoption: Aging populations and longer disease durations expand potential user base.
2. Clinical Evidence: Emerging studies reinforce GOCOVRI’s role, facilitating prescriber confidence.
3. Market Access: Broadened payer coverage and patient assistance programs support uptake.

Forecasting and Market Potential

Analysts project a compound annual growth rate (CAGR) of 10-15% over the next five years, contingent upon factors including:

• Approval in new markets
• Extension of indications (e.g., early-stage PD or other dyskinesias)
• Competitive pressures and pricing strategies

Global expansion remains a pivotal shadow, with revenues potentially tripling if GOCOVRI gains approvals and market access in Europe and Asia. Nonetheless, competitive drug pipelines and generics threaten long-term market share.

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Challenges and Risks

• Generic Competition: Immediate-release amantadine remains inexpensive and available, risking erosion of GOCOVRI’s market share upon patent expiry.
• Regulatory Delays: Delays or denials in international markets could hamper revenue growth.
• Market Saturation: High adoption rates in the U.S. may temper growth, emphasizing the need for geographic expansion.

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Conclusion

GOCOVRI stands as a specialized, clinically meaningful therapy within the PD treatment space. Its market dynamics are shaped by evolving clinical needs, payer landscapes, and international regulatory developments. Financially, GOCOVRI’s trajectory appears cautiously optimistic, with potential for sustained growth driven by increased prevalence of PD, expanding indications, and geographical expansion. However, risks such as generics and competitive clinical developments necessitate vigilant strategic planning.

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Key Takeaways

• GOCOVRI’s unique extended-release profile confers clinical advantages, supporting its sustained market position.
• Growth hinges on expanding global approvals, broader insurance coverage, and demonstrating long-term efficacy.
• Competitive pressures from generics and new therapeutics pose challenges to sustained revenue.
• The potential for market expansion, especially internationally, remains a significant growth driver.
• Strategic partnerships, ongoing clinical research, and comprehensive payer engagement are critical to maximizing financial trajectory.

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FAQs

1. How does GOCOVRI differ from traditional amantadine formulations?
GOCOVRI’s extended-release formulation provides a stable plasma concentration over 24 hours, reducing dyskinesia more effectively and with improved compliance compared to immediate-release amantadine.

2. What is the current global regulatory status of GOCOVRI?
As of 2023, GOCOVRI is approved exclusively in the United States. International approval depends on local regulatory agencies, with ongoing submissions anticipated.

3. What are the main growth opportunities for GOCOVRI?
Opportunities include expanding to international markets, seeking approval for additional indications such as early-stage PD, and developing combination therapies.

4. What challenges could impact GOCOVRI’s financial prospects?
Key challenges include patent expiration leading to generic competition, delays in regulatory approvals, and emerging therapeutic alternatives.

5. How might healthcare payer policies influence GOCOVRI’s market penetration?
Reimbursement policies, formulary inclusion, and patient access programs directly impact prescribing patterns and sales volume.

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References

Last updated: July 27, 2025

[1] Friedman JH et al. "Efficacy of Extended-Release Amantadine in Parkinson’s Disease Dyskinesia." Mov Disord. 2017.
[2] Chopra N et al. "The Epidemiology of Parkinson’s Disease." Parkinson’s Disease, 2020.
[3] MarketResearch.com, “Pharmaceutical Market Trends 2022.”