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 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-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:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	3
Patent Applications:	1,449
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 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
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	208944-001	Aug 24, 2017		RX	Yes	No

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	208944-001	Aug 24, 2017
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017

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)	2014204933
Australia	2018320946
Australia	2024205201
Brazil	112020003375

Last updated: July 26, 2026

Gocovri (amantadine ER) Market Dynamics and Financial Trajectory (US)

Executive summary: Gocovri (amantadine) revenue trajectory is driven by (1) US formulary access and uptake of the extended-release product for dyskinesia in Parkinson’s disease, (2) substitution and competition from immediate-release amantadine and other Parkinson’s dyskinesia therapies, and (3) exclusivity and patent-driven generic entry risk. Financial performance is also sensitive to payer reimbursement, patient persistence, and utilization management shifts as branded share erodes and biosimilar-like brand pressure does not apply (Gocovri is a small-molecule branded drug). The exclusivity/patent estate timing and Orange Book status determine the competitive inflection point for generic pressure.

What is Gocovri and what market does it serve (Parkinson’s dyskinesia, how sold, who buys)?

Gocovri is amantadine extended-release (ER) indicated for treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease. Market demand is therefore tightly linked to:

• Neurology patient pool size (patients on chronic levodopa who develop dyskinesia)
• Treatment sequencing (tolerance of levodopa regimen adjustments vs adding symptomatic therapies)
• Payer management (step edits, prior authorization, and formulary tiering for dyskinesia adjuncts)

How does Gocovri pricing and reimbursement typically shape adoption?

Gocovri is a branded specialty neurology product. In US markets, adoption and revenue realization usually depend on:

• Net-to-gross declines driven by rebates and discounts
• Higher unit economics volatility vs off-patent generics due to payer scrutiny
• Dose intensity stability (ER dosing supports persistence, but dyskinesia severity changes can still reduce adherence)

What are the main competitive categories Gocovri faces?

Even when direct generic substitution is not available, Gocovri competes indirectly with:

• Other adjuncts used to address dyskinesia (including non-amantadine strategies)
• Adjustments to dopaminergic therapy and device-assisted options (where used)
• Off-label use patterns within neurology prescribing discretion

What patents protect Gocovri and how do they control generic or follow-on entry risk?

Gocovri’s competitive timeline is governed by its Orange Book-listed patent estate covering active ingredient, formulation, and use. Market dynamics shift at the moment a generic applicant can enter the market under paragraph IV and win a settlement or at patent expiry.

How does Orange Book status translate into revenue risk windows?

In branded neurology small molecules like Gocovri, revenue risk typically clusters into two phases:

1. Pre-expiry: payer and channel stocking remain stable; branded share is protected
2. Post-expiry or post-PIIV settlement: generic entry drives rapid price erosion, then consolidation into fewer competitors

Which patent types matter most for market exclusivity?

For revenue and launch planning, the most consequential are:

• Composition of matter claims tied to the active ingredient and ER formulation
• Method-of-use claims linked to Parkinson’s dyskinesia treatment
• Manufacturing/formulation claims that can block “therapeutically equivalent” substitutes

When does Gocovri lose exclusivity and what are the likely generic entry scenarios?

The market’s “financial trajectory inflection point” is tied to the latest expiration of the patents that are listed for FDA approval and any extensions that delay generic entry.

What are the typical generic entry scenarios after patent expiry?

Revenue usually follows a pattern:

• Scenario A: Early generic launch via successful paragraph IV
  Faster branded share loss and steeper net price erosion.
• Scenario B: Post-expiry generic launch with delayed settlements
  More gradual share erosion depending on launch timing and payer switching rules.
• Scenario C: Authorized generic or “skinny” launch dynamics
  Blended revenue decline can occur with different rebate structures.

How does Gocovri compare with generic amantadine ER and immediate-release amantadine on formulary and uptake?

Why ER versus IR matters for payer switching

Even if the active ingredient is the same, ER dosing can influence:

• Prescriber preference and perceived tolerability
• Payer requirements for therapeutic equivalence and coverage policy
• Substitution decisions at pharmacy benefit managers

What does the substitution risk look like?

When an equivalent ER alternative exists, branded revenue typically experiences:

• Rapid reductions in script share
• Net price pressure from competitive bidding and rebate recalibration
• Increased use of preferred generics or authorized generics

What Paragraph IV challenges exist for Gocovri and how do settlements affect market share?

Paragraph IV litigation is the principal driver of “tempo” in branded-to-generic transitions. Financial trajectory depends on:

• Whether a challenger wins on one or more patents
• Settlement terms such as launch dates, territorial scope, and exclusivity swaps (where used)
• Court timelines that delay or accelerate entry

How does litigation timing show up in financial results?

In branded revenue, litigation-driven inflections typically show up as:

• Early increases in wholesaler orders ahead of launch dates
• Subsequent unit decline when generic supply reaches the market
• Margin pressure due to rebate escalations and payer renegotiations

What is the Orange Book status of Gocovri (listed patents, expiration dates, exclusivity periods)?

Orange Book listings are the authoritative map for:

• Which patents are tied to FDA approval
• Their expiration dates
• Whether additional exclusivity like pediatric exclusivity or patent term adjustments apply

What Orange Book elements most affect the competitive landscape?

For market planning and investment-grade forecasting, these are the critical fields:

• Patent number
• Patent type (composition, method-of-use, formulation, etc.)
• Expiration date and any pediatric exclusivity overlay
• Relevant exclusivity blocks that determine generic timing

What formulations are protected for Gocovri and what manufacturing/IP barriers exist?

Formulation and manufacturing claims determine whether a generic can file and launch with:

• The same dose strengths and release characteristics
• Comparable bioavailability and ER pharmacokinetic profiles
• Equivalent manufacturing quality systems and process parameters

How do formulation patents delay “equivalent” competition?

Even if a generic can replicate the active ingredient, ER formulation patents can delay:

• Launch approvals for certain dosage strengths
• Market entry through additional regulatory and legal hurdles
• Substitution decisions by prescribers who require consistent clinical behavior

What FDA regulatory pathway governs Gocovri and what does that imply for generic substitution?

Gocovri is an FDA-approved drug product with an ER formulation. For generics, the pathway is typically:

• ANDA (for small-molecule follow-ons)
• Therapeutic equivalence based on active ingredient and approved dosage form

What regulatory factors accelerate or delay entry?

Entry depends on:

• Bioequivalence study design
• Compatibility with ER release requirements
• Label alignment on indication and dosing

How strong is the patent estate for Gocovri (claim breadth, remaining life, enforcement posture)?

Financial resilience in the face of generic attempts is usually correlated with:

• Claim coverage breadth across formulation and method-of-use
• Remaining patent life into the expected generic filing window
• Historical enforcement posture and willingness to litigate

What weak points can create market erosion even before expiry?

Market share can decline before legal expiry when:

• Payers pre-contract or build preferred generic directories
• Prescribers switch to non-brand alternatives based on pilot results
• Authorized generics or “launch-ready” competitors enter distribution channels

Which companies challenge or could challenge Gocovri (generic manufacturers, authorized generics)?

The identity of challengers is typically revealed through:

• ANDA submissions and patent certification notices (paragraph IV)
• Litigation dockets tied to FDA approvals

How do challenger counts affect price and revenue decline shape?

More credible entrants usually compress price declines into a shorter period:

• First entrant sets the anchor
• Second and third entrants increase rebate pressure
• Retail pharmacy uptake can accelerate if payer coverage becomes automatic

What commercial metrics explain Gocovri’s financial trajectory (scripts, persistence, net price, mix)?

For branded specialty drugs, revenue is usually a function of:

• Prescription volume (new starts and continuation)
• Net selling price after rebates and discounts
• Geographic and payer mix
• Product mix across strengths (if relevant)

What does the expected trajectory look like across a typical life cycle?

For branded small-molecule neurotherapeutics:

1. Growth phase: new patient starts and formulary gains
2. Maturity phase: utilization management intensifies, net price compresses
3. Pre-exclusivity plateau: managed competition via alternative therapies
4. Post-exclusivity: price erosion and share loss driven by generics

How does Gocovri’s financial performance compare with other Parkinson’s dyskinesia therapies?

A defensible comparison framework uses:

• Time on market and remaining exclusivity
• Share sensitivity to generic entry
• Payer coverage stability and clinical positioning strength

What to watch when benchmarking revenue declines

• Net price changes tied to reimbursement renegotiation
• Unit share loss timing relative to generic launch
• Script persistence after new payer policies

Key Takeaways

• Gocovri’s market dynamics are determined by its role as amantadine ER for levodopa-induced dyskinesia in Parkinson’s disease, making demand sensitive to neurology treatment patterns and payer utilization management.
• Financial trajectory hinges on the Orange Book patent estate and any paragraph IV challenges, which set the timing and pace of generic price erosion.
• The exclusivity-to-generic transition typically produces a two-step outcome: pre-expiry stability with payer renegotiations, then post-expiry rapid net price and share declines.
• Competitive risk is not only direct generic substitution but also indirect dyskinesia management alternatives that can reduce new starts.

FAQs

1. How do prior authorization rules affect Gocovri net revenue versus gross sales?
2. What is the typical timeline for branded share decline once an amantadine ER generic is launched?
3. Do method-of-use patents for Gocovri delay generics more than formulation patents in practice?
4. How do settlements in paragraph IV cases influence payer switching and wholesaler buying ahead of launch?
5. What financial indicators best predict Gocovri revenue pressure in the quarter before exclusivity expiry?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA: Gocovri (amantadine) approval and labeling information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. ANDA Paragraph IV Certifications (general information on statutory framework). U.S. Food and Drug Administration. https://www.fda.gov/

DrugChatter Q&A for GOCOVRI

Does medicare cover gocovri?
How much does gocovri cost?
How does Gocovri treat Parkinson's levodopa-induced dyskinesia?
What are the neurological side effects of Gocovri?