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. Fifty-two 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:	5,077
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
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-001	Mar 11, 2014	AB2	RX	Yes	No	8,652,527		Y

International Patents for QUDEXY XR

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2968177	CAPSULE DE TOPIRAMATE À LIBÉRATION LENTE (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
Brazil	112015022434	cápsulas de topiramato de liberação estendida
South Korea	101674509
South Korea	20150132838	서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES)
World Intellectual Property Organization (WIPO)	2014143380

Supplementary Protection Certificates for QUDEXY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0138441	SPC/GB95/028	United Kingdom		PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
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

QUDEXY XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Qudexy XR

Introduction to Qudexy XR

Qudexy XR (topiramate) Extended-Release Capsules is a prescription medication approved by the FDA for several indications, including the prophylaxis of migraine headaches in adults and adolescents, as well as the treatment of various types of seizures. Here, we will delve into the market dynamics and financial trajectory of Qudexy XR.

Market Indications and Approval

Qudexy XR received FDA approval in March 2017 for the prophylaxis of migraine headaches in adults and adolescents 12 years and older. This approval marked a significant expansion of its indications, making it a valuable option for neurologists and patients alike[1].

Competitive Landscape

The market for migraine prophylaxis and antiepileptic drugs is highly competitive. Qudexy XR competes with other extended-release formulations of topiramate, such as Trokendi XR by Supernus Pharmaceuticals. Despite this competition, Qudexy XR has carved out a niche due to its unique 100% extended-release bead formulation, which provides a smooth pharmacokinetic profile and reduces peak-to-trough fluctuations of topiramate plasma concentrations[5].

Prescription Growth and Market Performance

In recent years, Qudexy XR has shown robust prescription growth. While specific data on Qudexy XR's prescription growth is not provided, the overall market for topiramate extended-release formulations has seen significant activity. For instance, Supernus Pharmaceuticals' Trokendi XR, another topiramate extended-release product, experienced a 5.3% increase in prescriptions in 2019 compared to 2018, despite intensified competition[3].

Financial Performance

The financial performance of Qudexy XR is closely tied to its prescription volume and market share. Upsher-Smith Laboratories, the manufacturer of Qudexy XR, benefits from the drug's approval and subsequent market acceptance. However, detailed financial figures specific to Qudexy XR are not publicly disclosed.

Impact of Managed Care and Market Pressures

The pharmaceutical industry, including the market for Qudexy XR, faces significant pressures from managed care and gross-to-net deductions. These factors can impact net sales despite increasing prescription volumes. For example, Supernus Pharmaceuticals reported that while prescriptions for Trokendi XR grew, net product sales were down due to inventory build and managed care pressures[3].

Patient Adherence and Compliance

Patient adherence to migraine prophylaxis medications is a critical factor in their financial trajectory. Studies have shown that adherence to these medications can be as low as 41% at two months and declines further over time. Qudexy XR's once-daily dosing and flexible administration (it can be taken with or without food and even sprinkled onto soft food for patients with swallowing difficulties) are designed to improve adherence, potentially leading to better patient outcomes and higher revenue[1].

Side Effects and Safety Considerations

While Qudexy XR offers several benefits, it also comes with significant side effects and safety considerations. These include serious eye problems, decreased sweating and fever, metabolic acidosis, and increased risk of suicidal behavior. These factors can influence prescribing decisions and patient compliance, which in turn affect the drug's financial performance[2].

Dosage and Administration

The unique extended-release formulation of Qudexy XR allows for a smooth delivery of topiramate over 24 hours, reducing the need for multiple daily doses. This formulation maintains topiramate levels without the peak drug levels associated with immediate-release formulations, which can enhance patient compliance and satisfaction[5].

Clinical Studies and Efficacy

Clinical studies have supported the efficacy of Qudexy XR in migraine prophylaxis and epilepsy treatment. The drug has been shown to meet criteria for bioequivalence with immediate-release topiramate from day one after switching, ensuring no change in total daily dose is needed. This seamless transition can help in maintaining patient trust and adherence[5].

Future Outlook and Competitive Strategies

Looking ahead, the market for Qudexy XR is expected to face continued competitive pressure, particularly from other extended-release topiramate formulations. To maintain market share, Upsher-Smith Laboratories may focus on enhancing patient education programs, improving adherence strategies, and exploring partnerships or corporate development opportunities to expand its reach.

Key Takeaways

• Unique Formulation: Qudexy XR's 100% extended-release bead formulation provides a smooth pharmacokinetic profile.
• Market Approval: Approved for migraine prophylaxis in adults and adolescents, and various seizure types.
• Competitive Landscape: Competes with other topiramate extended-release products like Trokendi XR.
• Prescription Growth: Shows robust prescription growth despite market pressures.
• Financial Performance: Impacted by managed care and gross-to-net deductions.
• Patient Adherence: Designed to improve adherence with once-daily dosing and flexible administration.
• Safety Considerations: Associated with significant side effects that can influence prescribing decisions.

FAQs

1. What is Qudexy XR used for? Qudexy XR is used for the prophylaxis of migraine headaches in adults and adolescents, as well as the treatment of various types of seizures, including partial-onset seizures and primary generalized tonic-clonic seizures.

2. How is Qudexy XR administered? Qudexy XR can be taken once daily, with or without food, and can also be administered by opening the capsule and sprinkling the contents onto a small amount of soft food.

3. What are the common side effects of Qudexy XR? Common side effects include tingling of the arms and legs, weight loss, nervousness, nausea, speech problems, tiredness, dizziness, and sleepiness/drowsiness.

4. How does Qudexy XR compare to immediate-release topiramate? Qudexy XR provides a smooth pharmacokinetic profile with reduced peak-to-trough fluctuations of topiramate plasma concentrations compared to immediate-release formulations.

5. What are the serious safety considerations associated with Qudexy XR? Serious safety considerations include acute myopia and secondary angle closure glaucoma, visual field defects, oligohydrosis and hyperthermia, metabolic acidosis, and increased risk of suicidal behavior.

Cited Sources

1. Upsher-Smith Laboratories. FDA Approves Expanded Indication for Qudexy XR (topiramate) Extended-Release Capsules to Include Prophylaxis of Migraine Headache in Adults and Adolescents. March 30, 2017.
2. FDA. Qudexy XR - accessdata.fda.gov. Revised: 2/2021.
3. Supernus Pharmaceuticals. Additional Highlights and Achievements in 2019. February 28, 2020.
4. FDA. Qudexy XR - accessdata.fda.gov. March 2017.
5. Upsher-Smith Laboratories. PK Data | Qudexy® XR (topiramate) Extended-Release Capsules.