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 nineteen patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five 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:	35
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	2
Patent Applications:	4,015
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
Oregon Health and Science University	Phase 4
Adamas Pharmaceuticals, Inc.	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-one US patents and one FDA Regulatory Exclusivity.

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			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
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
Mexico	2020002078	COMPOSICIONES DE AMANTADINA, PREPARACIONES DE ESTAS Y MÉTODOS DE USO. (AMANTADINE COMPOSITIONS, PREPARATIONS THEREOF, AND METHODS OF USE.)
Japan	2023009251	アマンタジン組成物、その調製、および使用方法
Japan	2020531543	アマンタジン組成物、その調製、および使用方法
European Patent Office	2506709	COMPOSITIONS D'AMANTADINE ET PROCÉDÉS D'UTILISATION ASSOCIÉS (AMANTADINE COMPOSITIONS AND METHODS OF USE)

GOCOVRI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GOCOVRI

Introduction to GOCOVRI

GOCOVRI, an extended-release formulation of amantadine, is a significant treatment option for patients with Parkinson’s disease, particularly those experiencing motor complications such as dyskinesia and OFF episodes. Developed by Adamas Pharmaceuticals and now part of Supernus Pharmaceuticals' portfolio, GOCOVRI has been making notable strides in the pharmaceutical market.

Clinical Significance and Efficacy

GOCOVRI has demonstrated its efficacy in several clinical trials. A post-hoc analysis from two placebo-controlled Phase 3 clinical trials showed that GOCOVRI significantly improved motor aspects of daily living for patients with Parkinson’s disease and dyskinesia. These improvements included reductions in freezing, tremor, and difficulties in getting out of bed or a car[3].

Market Performance

Sales Growth

GOCOVRI has consistently shown strong sales growth. In the second quarter of 2024, net sales of GOCOVRI increased by 10% compared to the same period in 2023, reaching $31.7 million. For the first six months of 2024, net sales were $58.3 million, indicating a steady upward trend[1].

In the third quarter of 2024, GOCOVRI's net sales increased by 8% compared to the same period in 2023, with sales of $35.6 million and $93.9 million for the third quarter and first nine months of 2024, respectively[5].

Prescription Volume

The prescription volume for GOCOVRI has also seen significant growth. In the second quarter of 2022, GOCOVRI prescriptions reached 10,929, representing a 16% growth compared to the second quarter of 2021[1].

Financial Trajectory

Revenue Contribution

GOCOVRI has been a key contributor to Supernus Pharmaceuticals' revenue. For the three and nine months ended September 30, 2024, total net product sales were $170.3 million and $471.3 million, respectively. The increase in these periods was primarily driven by the growth in net sales of GOCOVRI and another product, Qelbree, partially offset by the decline in net product sales of Trokendi XR due to generic erosion[2].

Operating Earnings

The financial performance of Supernus Pharmaceuticals has been positively impacted by GOCOVRI's sales. Operating earnings for the three and nine months ended September 30, 2024, were $40.9 million and $60.3 million, respectively, compared to operating earnings (loss) of $8.1 million and $(4.3) million for the same periods in 2023. Adjusted operating earnings (non-GAAP) also saw significant increases, reaching $67.7 million and $135.4 million for the three and nine months ended September 30, 2024[2].

Market Dynamics

Parkinson's Disease Market Growth

The Parkinson's disease market is expected to grow significantly, with a projected CAGR of 5.8% from 2020 to 2034. This growth is driven by advancements in diagnostic techniques, increased awareness, and a rising number of reported cases. The emerging pipeline, including therapies like SPN-830 from Supernus Pharmaceuticals and Britannia Pharmaceuticals, is expected to further impact the market dynamics[4].

Competitive Landscape

GOCOVRI operates in a competitive landscape that includes other treatments for Parkinson’s disease. However, its unique extended-release formulation and the ability to provide more predictable "ON" time for patients make it a valuable option. The adjunctive use of GOCOVRI without requiring dose changes to dopaminergic therapies is another advantage[3].

Safety and Adverse Reactions

While GOCOVRI has shown significant clinical benefits, it also comes with potential adverse reactions. The most common adverse reactions include hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension. It is crucial for healthcare providers to monitor patients for these side effects, especially at the initiation of treatment or after dose increases[3].

Future Outlook

Pipeline and Regulatory Activities

Supernus Pharmaceuticals continues to work on expanding its portfolio, including the potential resubmission of the New Drug Application for SPN-830, an apomorphine infusion device for the continuous treatment of motor fluctuations in Parkinson’s disease. This development could further strengthen Supernus' position in the Parkinson’s disease market[1].

Market Expansion

The growing demand for effective treatments in the Parkinson’s disease market, coupled with GOCOVRI's proven efficacy, positions the drug for continued market expansion. As the market continues to evolve with new therapies and diagnostic advancements, GOCOVRI is likely to remain a key player.

Key Takeaways

• Sales Growth: GOCOVRI has shown consistent sales growth, with a 10% increase in the second quarter of 2024 and an 8% increase in the third quarter of 2024.
• Clinical Efficacy: GOCOVRI significantly improves motor aspects of daily living for patients with Parkinson’s disease and dyskinesia.
• Financial Impact: GOCOVRI is a major contributor to Supernus Pharmaceuticals' revenue and operating earnings.
• Market Dynamics: The Parkinson’s disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034, driven by advancements and increasing awareness.
• Safety Profile: While effective, GOCOVRI comes with potential adverse reactions that require monitoring.

FAQs

What is GOCOVRI used for?

GOCOVRI is used to treat motor complications in patients with Parkinson’s disease, including dyskinesia and OFF episodes.

How does GOCOVRI improve motor function in Parkinson’s disease?

GOCOVRI improves motor function by reducing symptoms such as freezing, tremor, and difficulties in getting out of bed or a car, as shown in clinical trials.

What are the common adverse reactions associated with GOCOVRI?

Common adverse reactions include hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.

How has GOCOVRI performed in terms of sales?

GOCOVRI has shown significant sales growth, with a 10% increase in the second quarter of 2024 and an 8% increase in the third quarter of 2024 compared to the same periods in 2023.

What is the future outlook for GOCOVRI in the Parkinson’s disease market?

GOCOVRI is expected to continue its market expansion as the Parkinson’s disease market grows, driven by advancements and increasing awareness, and with potential new therapies emerging in the pipeline.

Sources

1. Supernus Announces Second Quarter 2024 Financial Results - GlobeNewswire
2. Supernus Announces Third Quarter 2024 Financial Results - Biospace
3. New Data Analysis Supports GOCOVRI as an Important Treatment ... - Biospace
4. Parkinson's Disease Market is Expected to Showcase a Significant Growth ... - GlobeNewswire
5. Supernus Announces Third Quarter 2024 Financial Results - GlobeNewswire