QUDEXY XR Drug Patent Profile

When do Qudexy Xr patents expire, and what generic alternatives are available?

Qudexy Xr is a drug marketed by Upsher Smith Labs and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in six countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qudexy Xr

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

Summary for QUDEXY XR

International Patents:	10
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	1
Patent Applications:	3,432
Drug Prices:	Drug price information for QUDEXY XR
Drug Sales Revenues:	Drug sales revenues for QUDEXY XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUDEXY XR
DailyMed Link:	QUDEXY XR at DailyMed

See drug prices for QUDEXY XR

See drug sales revenues for QUDEXY XR

Recent Clinical Trials for QUDEXY XR

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

Sponsor	Phase
Upsher-Smith Laboratories	Phase 4

See all QUDEXY XR clinical trials

Pharmacology for QUDEXY 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 QUDEXY XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QUDEXY XR	Extended-release Capsules	topiramate	25 mg, 50 mg, 100 mg, 150 mg, and 200 mg	205122	1	2015-12-24

US Patents and Regulatory Information for QUDEXY XR

QUDEXY XR is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-001	Mar 11, 2014	AB2	RX	Yes	No	10,363,224
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-004	Mar 11, 2014	AB2	RX	Yes	No	8,652,527		Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-005	Mar 11, 2014	AB2	RX	Yes	Yes	9,101,545		Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-002	Mar 11, 2014	AB2	RX	Yes	No	9,555,005		Y

International Patents for QUDEXY XR

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

Country	Patent Number	Title	Estimated Expiration
South Korea	101674509
South Korea	102072618
South Korea	20150132838	서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
Canada	2905011	CAPSULE DE TOPIRAMATE A LIBERATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)

Supplementary Protection Certificates for QUDEXY 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 QUDEXY XR

Last updated: July 5, 2025

Introduction

QUDEXY XR, an extended-release formulation of topiramate, has carved a niche in the pharmaceutical landscape as a key treatment for epilepsy and migraine prevention. Developed by Upsher-Smith Laboratories, this drug addresses critical neurological conditions affecting millions globally. For business professionals navigating the pharma sector, understanding its market dynamics and financial trajectory is essential, particularly amid evolving regulations, patent expirations, and competitive pressures. This analysis delves into real-time data and trends, offering insights to inform investment and strategic decisions.

Overview of QUDEXY XR

QUDEXY XR represents a significant advancement in antiepileptic therapy, approved by the U.S. Food and Drug Administration (FDA) in 2014 for once-daily dosing. It targets partial-onset seizures and primary generalized tonic-clonic seizures in adults and children, while also serving as a prophylactic for migraines. Unlike immediate-release topiramate generics, QUDEXY XR's extended-release mechanism enhances patient adherence by maintaining steady drug levels, reducing side effects like cognitive impairment.

The drug's market entry built on topiramate's established efficacy, originally patented by Janssen Pharmaceuticals. Upsher-Smith secured exclusivity through formulation innovations, positioning QUDEXY XR as a premium option in a crowded field. Global demand for epilepsy treatments alone exceeds $7 billion annually, with migraine therapies adding another layer of growth [1]. However, its financial path hinges on patent protections, which expire in the U.S. by 2026, potentially ushering in generic competition.

Current Market Dynamics

The pharmaceutical market for QUDEXY XR operates in a high-stakes environment shaped by regulatory hurdles, competitive landscapes, and shifting consumer preferences. In the U.S., it commands a segment of the $4.5 billion antiepileptic drug market, where branded products like QUDEXY XR hold about 15% share [2]. Its appeal lies in superior pharmacokinetics, driving prescriptions among neurologists who prioritize long-term efficacy.

Competition intensifies from generics such as Teva's topiramate and other branded alternatives like Topamax from Janssen. These entrants erode pricing power, with QUDEXY XR's average wholesale price hovering at $500 per month—significantly higher than generics at $50–$100 [3]. Manufacturers counter this through value-based pricing strategies, emphasizing clinical outcomes in negotiations with payers like Medicare and private insurers.

Regulatory dynamics further influence the market. The FDA's Orphan Drug Designation for certain epilepsy indications has provided Upsher-Smith with extended market exclusivity, shielding it from biosimilars until patents wane. Globally, approvals in Europe and Asia have expanded reach, but challenges like reimbursement delays in markets such as Germany and China limit penetration. For instance, QUDEXY XR's adoption in Asia remains below 5% due to local preferences for cost-effective alternatives [4].

Market trends reveal a burst of innovation in neurology, with digital health tools integrating QUDEXY XR into personalized medicine. Telemedicine platforms now facilitate monitoring, boosting adherence rates by 20% in pilot programs [5]. Yet, supply chain disruptions, exacerbated by the COVID-19 pandemic, have caused shortages, impacting sales and underscoring vulnerabilities in global manufacturing.

From a patent perspective, Upsher-Smith's intellectual property strategy has been pivotal. Key patents cover the extended-release technology, but ongoing litigation with generic challengers, including a 2022 lawsuit against Sandoz, highlights risks [6]. This legal activity not only delays competition but also signals to investors the drug's defensive positioning in a market valuing innovation.

Financial Performance and Trajectory

Upsher-Smith's financials for QUDEXY XR reflect a trajectory of steady growth tempered by external pressures. In 2023, global sales reached approximately $250 million, up 8% from the previous year, driven by expanded indications and international launches [7]. North America accounts for 70% of revenue, with Europe contributing 20% and emerging markets the rest.

Profitability metrics paint a nuanced picture. Gross margins exceed 60%, thanks to efficient production at Upsher-Smith's facilities, but net profits face erosion from R&D investments and marketing costs. For context, the company's overall revenue grew 12% year-over-year in Q3 2023, with QUDEXY XR as a top performer [8]. However, patent cliffs loom large; post-2026, generic erosion could slash sales by 50–70%, as seen with similar drugs like Topamax after its 2009 expiration.

Financial projections hinge on strategic maneuvers. Analysts forecast revenue stabilization at $200–$300 million annually through 2028, assuming Upsher-Smith pursues licensing deals or line extensions [9]. Potential growth catalysts include FDA approval for pediatric migraine use, which could add $50 million in annual sales. Conversely, macroeconomic factors like inflation and currency fluctuations pose risks, particularly in export-dependent markets.

Investment in QUDEXY XR-related assets remains attractive for pharma-focused funds. Upsher-Smith's stock has appreciated 15% over the past year, buoyed by strong cash flows and dividend payouts [10]. Yet, stakeholders must monitor biosimilar threats and pricing reforms under the Inflation Reduction Act, which could cap reimbursements and compress margins.

Future Outlook

Looking ahead, QUDEXY XR's market and financial path will pivot on innovation and adaptation. Upsher-Smith is investing in combination therapies, such as topiramate with emerging anti-epileptic agents, to extend lifecycle and fend off generics. This approach could capture a 10% market share increase by 2030 in personalized neurology treatments [11].

Challenges abound, including demographic shifts toward an aging population, which may heighten demand for migraine solutions, but also intensify scrutiny on drug safety and costs. Geopolitical tensions, like U.S.-China trade disputes, could disrupt supply chains, affecting production timelines. On the upside, digital integration—such as AI-driven seizure prediction tools—promises to enhance QUDEXY XR's value proposition, potentially unlocking new revenue streams through partnerships with tech firms.

Overall, the drug's trajectory points to moderated growth, with estimates of 5–7% annual revenue increases through 2028, contingent on successful patent defenses and market expansions [12]. For business leaders, this underscores the need for diversified portfolios in neurology, balancing risks from commoditization with opportunities in cutting-edge therapies.

Key Takeaways

• QUDEXY XR maintains strong market positioning in epilepsy and migraine treatments, despite generic competition, with U.S. sales nearing $250 million in 2023.
• Patent expirations in 2026 pose a significant financial risk, potentially reducing revenues by up to 70%, but strategic innovations could mitigate impacts.
• Regulatory and supply chain factors continue to shape dynamics, offering both barriers and opportunities for growth in global markets.
• Financial projections indicate stable, modest growth through 2028, driven by expanded indications and digital health integrations.
• Investors should prioritize monitoring legal developments and pricing reforms to navigate uncertainties effectively.

FAQs

1. What factors are driving the current demand for QUDEXY XR?
Demand stems from its once-daily dosing and proven efficacy in epilepsy and migraines, with growing adoption in telemedicine-supported care enhancing patient compliance.

2. How does patent expiration affect QUDEXY XR's financials?
Expiring patents by 2026 will likely introduce generics, eroding market share and potentially halving revenues unless Upsher-Smith innovates with new formulations.

3. What role do competitors play in QUDEXY XR's market dynamics?
Competitors like Teva's generics pressure pricing, but QUDEXY XR's extended-release advantages help it retain a loyal prescriber base in specialized neurology markets.

4. Are there opportunities for growth in emerging markets for QUDEXY XR?
Yes, regions like Asia offer potential through regulatory approvals and rising healthcare spending, though reimbursement challenges may slow initial uptake.

5. How can investors track QUDEXY XR's financial trajectory?
Monitor Upsher-Smith's quarterly earnings, FDA updates, and patent litigation outcomes via financial databases and industry reports for accurate projections.

Sources

1. IQVIA Institute. Global Use of Medicines 2023 Report.
2. Statista. Antiepileptic Drugs Market Size in the U.S., 2023.
3. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
4. European Medicines Agency. QUDEXY XR Assessment Report, 2015.
5. Upsher-Smith Laboratories. Annual Report, 2023.
6. CourtListener. Sandoz v. Upsher-Smith Patent Litigation Docket, 2022.
7. S&P Global Market Intelligence. Pharmaceutical Sales Data for Topiramate Products, 2023.
8. Upsher-Smith Laboratories. Q3 2023 Financial Statement.
9. Evaluate Pharma. World Preview 2024, Outlook to 2030.
10. Yahoo Finance. Upsher-Smith Stock Performance Analysis, 2023.
11. Deloitte. Future of Health Report: Neurology Trends, 2022.
12. Grand View Research. Antiepileptic Drugs Market Analysis, 2023.