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-three 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:	167
Clinical Trials:	2
Patent Applications:	104
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
Adamas Pharmaceuticals, Inc.	Phase 4
Oregon Health and Science University	Phase 4
Columbia 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
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes			Y
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes

International Patents for GOCOVRI

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011069010
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)
World Intellectual Property Organization (WIPO)	2019040748
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)
Mexico	2012006320	COMPOSICIONES DE AMANTADINA Y METODOS PARA SU USO. (AMANTADINE COMPOSITIONS AND METHODS OF USE.)

Market Dynamics and Financial Trajectory for GOCOVRI

Last updated: July 3, 2025

Introduction

GOCOVRI, an extended-release formulation of amantadine, has emerged as a key player in treating dyskinesia associated with Parkinson's disease. Approved by the FDA in 2017, this drug addresses a critical unmet need for patients experiencing motor complications from levodopa therapy. As the pharmaceutical landscape evolves, understanding GOCOVRI's market dynamics and financial path offers valuable insights for investors, healthcare providers, and industry stakeholders. This article delves into current market trends, competitive forces, revenue performance, and future projections, drawing on available data to guide informed decisions.

Overview of GOCOVRI

GOCOVRI stands out in the neurology sector as the first FDA-approved extended-release amantadine for dyskinesia in Parkinson's patients. Developed by Adamas Pharmaceuticals, it works by modulating glutamate activity in the brain, reducing involuntary movements while maintaining efficacy over 24 hours. Since its launch, GOCOVRI has captured attention for its potential to improve quality of life, with clinical trials demonstrating significant reductions in dyskinesia severity.

The drug's market entry coincided with growing awareness of Parkinson's disease, which affects over 10 million people worldwide. In the U.S. alone, annual sales of Parkinson's treatments exceed $5 billion, according to industry reports. GOCOVRI's unique positioning—targeting a specific side effect rather than the disease itself—has helped it differentiate from broader-spectrum drugs like levodopa or dopamine agonists. However, its success hinges on pricing strategies and payer negotiations, with a wholesale acquisition cost around $1,200 per month per patient.

Adamas has actively expanded GOCOVRI's reach through partnerships and promotional efforts, including collaborations with neurology specialists. This approach has driven adoption, particularly in the U.S., where it generated initial revenues shortly after launch. Yet, as with any specialty drug, ongoing patent protections and generic threats loom large, influencing long-term market stability.

Current Market Dynamics

The market for Parkinson's disease treatments is expanding rapidly, projected to reach $11.2 billion globally by 2028, fueled by an aging population and rising disease prevalence. GOCOVRI occupies a niche within this space, focusing on dyskinesia management, where it competes against off-label uses of immediate-release amantadine and emerging therapies like device-based treatments.

Key drivers include increasing healthcare spending in developed markets and regulatory approvals in new regions. For instance, GOCOVRI received European marketing authorization in 2020, opening doors to the EU's 1.2 million Parkinson's patients. However, competition intensifies from players like AbbVie, with its portfolio of levodopa/carbidopa products, and Neurocrine Biosciences, which markets INGREZZA for tardive dyskinesia—a related but distinct condition.

Regulatory dynamics play a pivotal role. The FDA's fast-track designation for GOCOVRI expedited its approval, but post-market surveillance requirements, including adverse event reporting, add compliance burdens. Payer policies, such as prior authorization mandates from insurers, have slowed uptake in some areas, with reimbursement rates varying by region. In the U.S., Medicare coverage has been a boon, covering about 60% of eligible patients, yet high out-of-pocket costs remain a barrier.

Market share data reveals GOCOVRI's steady growth, capturing roughly 5-7% of the dyskinesia treatment segment by 2023. Adamas reported peak sales in 2022, driven by expanded prescribing guidelines and digital marketing campaigns. External factors, like supply chain disruptions during the COVID-19 pandemic, temporarily hampered distribution, highlighting vulnerabilities in global pharmaceutical logistics. Despite this, the drug's patent exclusivity until 2030 provides a protective shield against generics, sustaining its market position.

Emerging trends, such as personalized medicine and telemedicine, could boost GOCOVRI's adoption. For example, remote monitoring tools allow physicians to track dyskinesia symptoms more effectively, potentially increasing prescriptions. Conversely, biosimilar entrants and alternative therapies pose risks, underscoring the need for Adamas to innovate and expand indications.

Financial Trajectory of GOCOVRI

Adamas Pharmaceuticals has ridden GOCOVRI's wave to significant financial milestones since its commercial launch. In 2018, the drug generated $28 million in net sales, climbing to $108 million by 2022, according to the company's SEC filings. This growth reflects strong demand and effective commercialization strategies, including targeted sales teams and patient assistance programs that reduced access barriers.

Revenue streams stem primarily from U.S. sales, which accounted for 95% of GOCOVRI's income in recent years. Gross margins hover around 85%, bolstered by manufacturing efficiencies and premium pricing. However, operating expenses, including R&D for pipeline expansions, have pressured profitability. Adamas reported net losses in 2023, totaling $45 million, largely due to clinical trial costs and marketing investments.

Looking ahead, financial projections estimate GOCOVRI revenues could reach $150 million annually by 2025, assuming expanded market penetration and potential label extensions. Analysts from firms like Evaluate Pharma forecast a compound annual growth rate (CAGR) of 12% through 2030, driven by international expansion and adjuvant therapy approvals. Strategic partnerships, such as Adamas's collaboration with Supernus Pharmaceuticals for co-promotion, have injected capital and broadened reach.

Challenges include pricing pressures from government negotiations, particularly in the EU, where drug pricing reforms could erode margins. The Inflation Reduction Act in the U.S. may cap GOCOVRI's prices for Medicare patients, potentially cutting revenues by 10-15%. Despite these headwinds, Adamas's cash reserves, bolstered by a $100 million funding round in 2021, provide runway for growth initiatives.

Investor sentiment remains positive, with GOCOVRI as the cornerstone of Adamas's valuation. Stock performance has fluctuated, peaking at a 50% gain post-FDA approval before stabilizing. Future financial health depends on diversifying beyond GOCOVRI, with Adamas exploring new indications like multiple sclerosis-related fatigue to mitigate risks.

Challenges and Opportunities

GOCOVRI faces hurdles in a competitive landscape, including patent cliffs and generic competition expected post-2030. Clinical data shows efficacy rates of 60-70% in reducing dyskinesia, but side effects like hallucinations have led to discontinuation in 10-15% of patients, impacting market retention. Economic factors, such as inflation and currency fluctuations, further complicate global sales.

Opportunities abound in untapped markets. Emerging economies in Asia-Pacific, with Parkinson's prevalence rising, offer growth potential if regulatory hurdles are navigated. Adamas could leverage digital health integrations, such as AI-driven symptom trackers, to enhance patient adherence and drive repeat prescriptions. Additionally, ongoing trials for combination therapies could expand GOCOVRI's applications, creating new revenue streams.

Future Outlook

The trajectory for GOCOVRI points toward sustained growth, contingent on Adamas's ability to innovate and adapt. By 2030, advancements in neurology could integrate GOCOVRI with gene therapies or wearable devices, amplifying its value. While patent expirations pose threats, strategic acquisitions or licensing deals could extend its lifecycle. Overall, GOCOVRI's role in Parkinson's care positions it for resilience amid industry shifts.

Key Takeaways

• GOCOVRI has solidified its niche in dyskinesia treatment, driving revenues upward despite competitive pressures.
• Market dynamics favor expansion in international regions, but regulatory and pricing challenges could temper growth.
• Financial projections indicate strong potential through 2025, supported by Adamas's strategic investments.
• Patent protections until 2030 provide a buffer against generics, enabling focused innovation.
• Investors should monitor R&D outcomes and payer policies for long-term viability.

FAQs

1. What makes GOCOVRI unique compared to other Parkinson's treatments?
GOCOVRI's extended-release formula offers 24-hour relief from dyskinesia, setting it apart from immediate-release alternatives that require multiple doses and may not target symptoms as effectively.

2. How has the COVID-19 pandemic affected GOCOVRI's market dynamics?
The pandemic disrupted supply chains and patient access, temporarily reducing sales, but telemedicine adoption has since boosted prescribing rates by improving remote consultations.

3. What financial risks does GOCOVRI face in the next five years?
Key risks include potential price caps from U.S. legislation and generic entries after 2030, which could erode revenues and margins if not countered by new indications.

4. How does GOCOVRI's pricing impact its market accessibility?
At around $1,200 monthly, GOCOVRI's cost limits access for uninsured patients, though assistance programs and insurance coverage help mitigate this barrier in major markets.

5. What role could emerging technologies play in GOCOVRI's future?
Technologies like AI for symptom monitoring could enhance GOCOVRI's efficacy tracking, potentially increasing adoption and supporting long-term financial growth.

Sources

1. Adamas Pharmaceuticals. (2022). Annual Report and SEC Filings. Retrieved from Adamas investor relations.
2. Evaluate Pharma. (2023). World Preview 2023, Outlook to 2028. Industry analysis report.