TROKENDI XR Drug Patent Profile

When do Trokendi Xr patents expire, 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-six 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:	103
Clinical Trials:	1
Patent Applications:	5,077
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	201635-003	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	9,555,004		Y
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-004	Aug 16, 2013	AB1	RX	Yes	Yes	9,622,983		Y

International Patents for TROKENDI XR

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

Country	Patent Number	Title	Estimated Expiration
Canada	2618240
European Patent Office	1973528
European Patent Office	2394643
Japan	5489719
Spain	2312308

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

Introduction

Trokendi XR, a once-daily extended-release topiramate product, has been a significant component of Supernus Pharmaceuticals' portfolio since its launch in 2013. Here, we will delve into the market dynamics and financial trajectory of Trokendi XR, highlighting its performance, challenges, and the company's strategic responses.

Product Overview

Trokendi XR is indicated for the treatment of epilepsy and the prophylaxis of migraine headaches in adults and adolescents. It was launched in 2013 for epilepsy and expanded to include migraine prophylaxis in 2017[1].

Historical Performance

Early Success

In the initial years following its launch, Trokendi XR showed robust growth. For instance, in 2020, it achieved an 8% increase in net sales over 2019, reaching an all-time high of $320 million. This growth was partly driven by an increase in the average size of monthly prescriptions[1].

Prescription Trends

Despite the overall growth, prescription trends for Trokendi XR have been mixed. In 2020, while prescriptions declined by 11.9% according to IMS data, the extended units (number of tablets) declined by a lesser 5.1% compared to 2019. This was attributed to larger monthly prescription sizes[1].

Challenges: Generic Erosion and Market Competition

Generic Competition

One of the significant challenges facing Trokendi XR is the impact of generic competition. Following the expiration of its patent, generic versions of topiramate have entered the market, leading to a decline in Trokendi XR's net sales. In the second quarter of 2024, net sales of Trokendi XR declined by 12% compared to the same period in 2023, and by 39% for the first six months of 2024[2].

Market Competition

The epilepsy and migraine treatment markets are highly competitive, with numerous therapeutic options available. This competition has intensified over the years, affecting Trokendi XR's market share. For example, in 2019, despite a 5.3% increase in prescriptions, net sales were down by 6.4% due to inventory build and managed care pressures[4].

Financial Impact

Revenue Decline

The decline in Trokendi XR's net sales has had a noticeable impact on Supernus Pharmaceuticals' overall revenue. In 2023, the full-year net product sales of Trokendi XR were significantly lower, contributing to a 64% decline compared to 2022. This decline was partially offset by the growth in other products like Qelbree and GOCOVRI[5].

Adjusted Financial Metrics

To provide a clearer picture of the company's financial health, Supernus often reports non-GAAP metrics that exclude Trokendi XR's net product sales. For instance, in 2023, total revenues excluding Trokendi XR net product sales increased by 26% compared to 2022, highlighting the growth in other product lines[5].

Strategic Responses

Diversification of Product Portfolio

Supernus has actively diversified its product portfolio to mitigate the impact of generic competition on Trokendi XR. The company has acquired and launched other CNS products, such as Qelbree and GOCOVRI, which have shown significant growth. Qelbree's net sales, for example, increased by 92% in the second quarter of 2024 compared to the same period in 2023[2].

Pipeline Development

Supernus is also focusing on its pipeline development to ensure long-term growth. The company is advancing several product candidates, including SPN-830 for Parkinson's disease treatment, which is anticipated to receive FDA approval and launch in the future. This pipeline development is crucial for addressing unmet medical needs and expanding the company's revenue streams[3].

Market Dynamics and Competitive Landscape

Industry Competition

The pharmaceutical industry, particularly the CNS therapeutic area, is highly competitive with a strong emphasis on innovation and pipeline development. Companies must continuously innovate and expand their product portfolios to maintain a competitive edge. Supernus' strategy to grow its newer products while developing its pipeline positions it well in this competitive landscape[3].

Regulatory and Market Factors

Market dynamics, including patent expirations and generic competition, play a significant role in a company's financial health. Supernus' adaptive approach to offsetting revenue losses from legacy products like Trokendi XR through the growth of newer products and pipeline development is a key strategy in navigating these challenges[3].

Conclusion

Trokendi XR has been a significant contributor to Supernus Pharmaceuticals' revenue, but its financial trajectory has been impacted by generic competition and market dynamics. Despite these challenges, the company has shown resilience through diversification of its product portfolio, strong pipeline development, and strategic transactions. As the pharmaceutical landscape continues to evolve, Supernus' ability to adapt and innovate will be crucial for its long-term success.

Key Takeaways

• Generic Erosion: Trokendi XR's net sales have declined due to generic competition.
• Market Competition: The epilepsy and migraine treatment markets are highly competitive.
• Diversification: Supernus has diversified its product portfolio to offset losses from Trokendi XR.
• Pipeline Development: The company is advancing several product candidates to ensure long-term growth.
• Financial Metrics: Non-GAAP metrics highlight the growth in other product lines.

FAQs

What is Trokendi XR used for?

Trokendi XR is used for the treatment of epilepsy and the prophylaxis of migraine headaches in adults and adolescents[1].

How has generic competition affected Trokendi XR?

Generic competition has led to a significant decline in Trokendi XR's net sales, with a 39% decline in the first six months of 2024 compared to the same period in 2023[2].

What steps is Supernus taking to offset the decline in Trokendi XR sales?

Supernus is diversifying its product portfolio with products like Qelbree and GOCOVRI, and is also focusing on pipeline development to ensure long-term growth[2][3].

How has the market competition impacted Trokendi XR?

The intense competition in the epilepsy and migraine treatment markets has affected Trokendi XR's market share and net sales, despite its initial success[4].

What are the key products driving Supernus' current revenue growth?

Products like Qelbree and GOCOVRI are driving Supernus' current revenue growth, with Qelbree's net sales increasing by 92% in the second quarter of 2024[2].

Sources

1. Supernus Pharmaceuticals - 2020 Annual Report[1]
2. GlobeNewswire - Supernus Announces Second Quarter 2024 Financial Results[2]
3. StockTitan - Supernus Announces Fourth Quarter and Full Year 2023 Financial Results[3]
4. Supernus Pharmaceuticals - 2019 Annual Report[4]
5. Supernus Pharmaceuticals - Fourth Quarter and Full Year 2023 Financial Results[5]