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-seven 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:	1
Clinical Trials:	1
Patent Applications:	2,695
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
Israel	241053	קפסולות של טופיראמאט עם שחרור מושהה (Extended-release topiramate capsules)
Canada	2905011	CAPSULE DE TOPIRAMATE A LIBERATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
Canada	2905011	CAPSULE DE TOPIRAMATE A LIBERATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
South Korea	20200010608	서방성 토피라메이트 캡슐 (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 27, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, stringent regulatory oversight, and intense competitive pressures. QUDEXY XR, a hypothetical extended-release formulation of an established drug, exemplifies a strategic approach to extending product life cycles and capturing novel market segments. Analyzing its market dynamics and financial trajectory requires understanding the drug’s therapeutic profile, regulatory landscape, market demand, competitive positioning, and potential revenue streams.

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Therapeutic Indication and Market Landscape

QUDEXY XR positions itself within the central nervous system (CNS) therapeutic category, likely targeting conditions like ADHD or narcolepsy, similar to existing extended-release stimulant drugs such as Concerta or Vyvanse. Given the increasing prevalence of such disorders—ADHD affects approximately 9.4% of children and 4.4% of adults in the U.S. alone (CDC, 2022)—the potential demand for new delivery systems remains substantial.

The unique formulation of QUDEXY XR offers prolonged therapeutic effect, improved adherence, and reduced dosing frequency, which caters to both patient convenience and compliance. Manufacturers typically leverage these advantages to capture market share, especially in healthcare systems emphasizing patient-centered care.

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Market Dynamics Influencing QUDEXY XR’s Trajectory

1. Regulatory Environment

Securing FDA approval hinges on demonstrating bioequivalence to the originator medication or providing clear therapeutic advantages. If QUDEXY XR gains approval through a 505(b)(2) pathway, it could capitalize on existing clinical data, expediting market entry. However, patent exclusivity, including formulation patents, crucially impacts initial market entry and pricing strategies. Patent expirations or litigation outcomes influence long-term market sustainability.

2. Competitive Landscape

The CNS drug market is heavily saturated with established brands and generics. Entry of QUDEXY XR introduces competition aimed at patients seeking newer, more convenient options. Differentiators like improved safety profiles, lower abuse potential, or superior efficacy can bolster market penetration. Nonetheless, generic competition post-patent expiration could dramatically erode revenue margins.

3. Pricing Strategy and Reimbursement

Pricing remains pivotal. Extended-release formulations often command premium prices due to convenience and patent protections. Negotiations with payers, insurance companies, and Medicaid influence reimbursement levels, thus affecting profitability. Value-based pricing aligned with demonstrated clinical benefits enhances market acceptance.

4. Prescriber and Patient Acceptance

Physician familiarity and preference for existing therapies influence prescribing trends. Educational campaigns highlighting QUDEXY XR’s benefits can foster adoption. Patient adherence improvements generate positive reviews, driving endogenous growth.

5. Distribution and Market Penetration

Distribution agreements with major pharmacy chains and hospital systems broaden availability. Launch strategies focusing on key opinion leaders (KOLs) and early adopters facilitate rapid market penetration.

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Financial Trajectory

1. Revenue Projections

Initial revenues will depend on myopic factors such as launch size, prescriber acceptance, and pricing. For instance, if the market for extended-release ADHD medications in the U.S. approximates $5 billion annually (IQVIA, 2022), capturing a conservative 2% market share in the first year equates to roughly $100 million in sales.

Growth hinges on expanding indications, optimizing formulary placement, and increasing prescriber adoption. A compound annual growth rate (CAGR) of 10–15% over five years is plausible, driven by increased awareness and competitive differentiation.

2. Cost Structure and Margins

Development costs include clinical trials, regulatory filings, and manufacturing setup, often exceeding $500 million for complex CNS drugs. Once commercialized, variable costs encompass manufacturing, distribution, and marketing, with gross margins potentially surpassing 70%. Efficient supply chain management and patent protections are critical for maintaining profitability.

3. Investment and Valuation

Investors will evaluate the drug’s projected cash flows, patent life, and competitive threats. A discounted cash flow (DCF) analysis incorporating sales forecasts, cost assumptions, and discount rates (~10%) typically guides valuation. Given high R&D expenses and market uncertainties, valuation is sensitive to uptake assumptions and regulatory outcomes.

4. Long-term Outlook

Post-patent expiry, revenue erosion intensifies as generics emerge, decreasing profit margins. Strategic alliances, line extensions, or novel indications (e.g., pediatric) could sustain pipeline revenue. Licensing or out-licensing agreements provide alternative revenue streams.

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Market Risks and Opportunities

• Risks: Patent challenges, pricing pressures, unfavorable regulatory decisions, or market cannibalization by generics threaten revenues. Additionally, safety concerns or adverse events can impair product reputation.
• Opportunities: Expanding into emerging markets, developing adjunctive therapies, or leveraging digital health solutions (e.g., adherence monitoring apps) enhance the drug’s value proposition.

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Conclusion

QUDEXY XR embodies a strategic extension in a well-established therapeutic area, positioning itself for substantial market capture contingent on regulatory success, competitive differentiation, and effective commercialization. Its financial trajectory will be marked by high initial investment and the potential for robust returns, tempered by patent life limitations and competitive pressures.

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Key Takeaways

• Market Potential: The demand for extended-release CNS drugs supports a promising revenue outlook, particularly in ADHD and narcolepsy markets.
• Regulatory Advantage: Strategic positioning via fast-tracked approvals and robust clinical data are critical for early market share capture.
• Competitive Factors: Patents, formulary placement, and prescriber acceptance determine market penetration and longevity.
• Financial Strategy: Careful pricing, cost management, and pipeline expansion are essential to maximize profitability.
• Long-term Outlook: Post-patent expiry planning, including line extensions and emerging markets, sustains financial health.

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FAQs

1. How does the patent status of QUDEXY XR influence its market potential?
Patent protections provide market exclusivity, allowing premium pricing and safeguarding significant revenue streams. Lapses or legal challenges to patents open the market for generics, which can erode profits.

2. What are the main regulatory considerations for launching QUDEXY XR?
Regulatory agencies assess safety, efficacy, and bioequivalence. A successful 505(b)(2) pathway leveraging existing data expedites approval, but proprietary formulation patents are essential for market exclusivity.

3. How does market competition impact QUDEXY XR’s financial prospects?
Established brands and generics exert downward price pressure. Differentiation through improved efficacy or convenience is vital for capturing intended market share and maintaining margins.

4. What role do payers and insurance companies play in the drug’s financial success?
Reimbursement policies determine accessible pricing and patient affordability. Negotiating favorable formulary position and demonstrating clinical value amplify sales potential.

5. How can QUDEXY XR sustain profitability after patent expiration?
Developing new formulations, expanding indications, entering emerging markets, and forming strategic alliances foster ongoing revenue generation despite generic competition.

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References

1. CDC. (2022). Data & Statistics on ADHD. Centers for Disease Control and Prevention.
2. IQVIA. (2022). The U.S. Prescription Drug Market Analysis. IQVIA Institute.