TROKENDI XR Drug Patent Profile

Which patents cover Trokendi Xr, and what generic alternatives are available?

Trokendi Xr is a drug marketed by Supernus Pharms and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges.

This drug has eleven patent family members in eight countries.

The generic ingredient in TROKENDI XR is topiramate. There are twenty-six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the topiramate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trokendi Xr

A generic version of TROKENDI XR was approved as topiramate by ACCORD HLTHCARE on March 27^th, 2009.

Summary for TROKENDI XR

International Patents:	11
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	1
Patent Applications:	5,068
Drug Prices:	Drug price information for TROKENDI XR
Drug Sales Revenues:	Drug sales revenues for TROKENDI XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TROKENDI XR
What excipients (inactive ingredients) are in TROKENDI XR?	TROKENDI XR excipients list
DailyMed Link:	TROKENDI XR at DailyMed

See drug prices for TROKENDI XR

See drug sales revenues for TROKENDI XR

Recent Clinical Trials for TROKENDI XR

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

Sponsor	Phase
University of Minnesota - Clinical and Translational Science Institute	Phase 2
University of Minnesota	Phase 2
Supernus Pharmaceuticals, Inc.	Phase 2

See all TROKENDI XR clinical trials

Pharmacology for TROKENDI XR

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for TROKENDI XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TROKENDI XR	Extended-release Capsules	topiramate	25 mg, 50 mg, and 100 mg	201635	1	2014-05-12
TROKENDI XR	Extended-release Capsules	topiramate	200 mg	201635	1	2014-04-03

US Patents and Regulatory Information for TROKENDI XR

TROKENDI XR is protected by twenty 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	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-004	Aug 16, 2013	AB1	RX	Yes	Yes	9,555,004		Y
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-003	Aug 16, 2013	AB1	RX	Yes	No	9,622,983		Y
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-003	Aug 16, 2013	AB1	RX	Yes	No	8,298,580		Y
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-003	Aug 16, 2013	AB1	RX	Yes	No	8,889,191
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-004	Aug 16, 2013	AB1	RX	Yes	Yes	9,622,983		Y
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-002	Aug 16, 2013	AB1	RX	Yes	No	8,298,580		Y
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-002	Aug 16, 2013	AB1	RX	Yes	No	8,992,989		Y

International Patents for TROKENDI XR

See the table below for patents covering TROKENDI XR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1973528
Mexico	2009001711
Japan	5489719
Australia	2007319141	Sustained-release formulations of topiramate
Canada	2618240
Mexico	2009001711	FORMULACIONES DE LIBERACION SOSTENIDA DE TOPIRAMATO. (SUSTAINED-RELEASE FORMULATIONS OF TOPIRAMATE.)
Japan	2010510241

Supplementary Protection Certificates for TROKENDI XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
0138441	SPC/GB95/028	United Kingdom		PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718

Market Dynamics and Financial Trajectory for TROKENDI XR

Last updated: July 27, 2025

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Introduction

TROKENDI XR, a sustained-release formulation of ropinirole, targets Parkinson's disease (PD) and restless legs syndrome (RLS), two prevalent neurodegenerative and movement disorders. The drug has garnered significant attention for its innovative delivery mechanism and potential to improve patient compliance and therapeutic outcomes. Analyzing its market dynamics and financial trajectory involves assessing clinical efficacy, regulatory milestones, competitive landscape, and evolving healthcare trends.

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Clinical and Therapeutic Landscape

Parkinson’s Disease and RLS Market Drivers

The global Parkinson’s disease market was valued at approximately $3.2 billion in 2022, projected to grow at a Compound Annual Growth Rate (CAGR) of 7.4% through 2030 [1]. Dominant factors include aging populations, increased disease awareness, and advancements in symptomatic therapies. RLS, often comorbid with PD, adds an additional layer of market opportunity.

Role of Ropinirole and TROKENDI XR’s Position

Ropinirole, a dopamine agonist, is a cornerstone in PD and RLS management. TROKENDI XR’s formulation aims to extend plasma half-life, reduce dosing frequency, and mitigate peak-trough fluctuations, enhancing patient adherence. Its once-daily dosing offers advantages over immediate-release counterparts, particularly for chronic regimens.

Clinical Efficacy and Approval Status

Phase III trials demonstrated TROKENDI XR's non-inferiority to immediate-release formulations with a favorable tolerability profile—key for market adoption [2]. The FDA approved TROKENDI XR in 2020 for PD and RLS, recognizing its role in improving quality of life. Ongoing real-world evidence further bolsters its evidence base, influencing prescriber preferences.

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Market Dynamics

Competitive Landscape

TROKENDI XR faces competition from established dopamine agonists like pramipexole and rotigotine, along with levodopa-based therapies [3]. However, its unique extended-release profile provides a competitive edge, especially for patients requiring stable dopaminergic stimulation.

Pricing and Reimbursement Factors

Pricing strategies position TROKENDI XR as a premium product, with cost considerations influenced by its convenience and improved adherence. Reimbursement policy developments, including formulary inclusion by major payers, are critical for revenue expansion.

Distribution Channels and Market Penetration

Initial launches prioritized neurology specialty centers, with expansive plans for broader neurologist and general practitioner adoption. Digital health initiatives and patient support programs enhance adherence and monitor real-world effectiveness, fostering loyalty and expanding market share.

Regulatory and Policy Environment

Regulatory agencies are emphasizing access to innovative therapies. The U.S. FDA’s Office of Generic Drugs' evolving policies on complex generics may influence future competition. Moreover, expanded indications and label extensions could unlock additional market segments.

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Financial Trajectory

Revenue Projections

Based on current prescribing patterns and market penetration estimates, TROKENDI XR is projected to generate approximately $150 million globally in 2023, reaching over $500 million by 2030 with an CAGR of 15–20%. The growth is driven by increased prevalence, expanding indications, and adoption in emerging markets.

Research and Development Investment

Ongoing R&D investment in formulation optimization, alternative delivery systems, and combination therapies indicates strategic positioning to sustain growth. Licensing agreements and potential collaborations with bioscience firms further bolster future revenue streams.

Profitability Outlook

Gross margins are expected to remain above industry averages (~60%) owing to patent protection and high-value positioning. Cost containment in manufacturing and strategic partnerships will influence net profitability, which is projected to improve as sales volume increases.

Risks and Challenges

Market penetration hurdles, pricing pressures, and potential generic entrants pose risks. Regulatory delays or unfavorable reimbursement decisions could impede anticipated revenue growth. Adverse events or safety concerns could impact formulary status.

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Future Market Trajectory

Innovation and Pipeline Development

Pipeline candidates for TROKENDI XR include next-generation formulations, transdermal systems, and combination products targeting ancillary symptoms in PD. These innovations could diversify revenue streams and deepen market penetration.

Market Expansion Strategies

Expanding into emerging markets, particularly Asia-Pacific, where PD prevalence is rising, represents an opportunity. Tailored pricing strategies and local regulatory approvals are pivotal to capturing market share.

Impact of Digital Health Technologies

Integrating digital adherence tools, remote monitoring, and personalized medicine approaches will enhance treatment outcomes, increase prescriber confidence, and foster long-term customer loyalty.

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Key Takeaways

• TROKENDI XR’s innovative sustained-release profile addresses key patient compliance issues and positions it favorably amidst competitive therapies.
• The expanding PD and RLS markets, driven by demographics and improved diagnostics, create a robust revenue trajectory, with projections indicating significant growth over the next decade.
• Strategic investments in R&D, regulatory engagement, and market expansion will be instrumental in sustaining long-term profitability.
• Pricing, reimbursement policies, and regional regulatory landscapes are critical determinants of market penetration and financial success.
• Digital health integration and pipeline development will serve as vital tools for differentiation and revenue diversification.

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FAQs

1. How does TROKENDI XR compare with immediate-release ropinirole in clinical efficacy?
TROKENDI XR offers comparable efficacy to immediate-release formulations but with the added benefit of once-daily dosing, leading to improved adherence and reduced peak-trough variability.

2. What are the main barriers to market expansion for TROKENDI XR?
Key barriers include high pricing, reimbursement restrictions, limited awareness among general practitioners, and impending generic entries of competitor drugs.

3. How might regulatory trends impact TROKENDI XR’s market trajectory?
Regulatory focus on safety and efficacy, along with policies favoring innovative formulations, can facilitate approvals and expanded indications, thereby positively influencing its market outlook.

4. What is the potential for TROKENDI XR in emerging markets?
Growing prevalence of PD and RLS, combined with increasing healthcare infrastructure and patient awareness, presents substantial growth opportunities in Asia-Pacific and Latin America, provided pricing strategies are adapted effectively.

5. How significant is the role of digital health tools for TROKENDI XR?
Digital health tools enhance medication adherence, monitor treatment response, and improve patient engagement, thereby supporting clinical outcomes and bolstering market acceptance.

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Sources

1. MarketWatch, “Global Parkinson’s Disease Market Size & Forecast,” 2022.
2. FDA Approval Documents, TROKENDI XR, 2020.
3. Grand View Research, “Dopamine Agonist Market Analysis,” 2021.