QUILLIVANT XR Drug Patent Profile

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

Quillivant Xr is a drug marketed by Nextwave and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in fourteen countries.

The generic ingredient in QUILLIVANT XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Quillivant Xr

A generic version of QUILLIVANT XR was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

Summary for QUILLIVANT XR

International Patents:	30
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Drug Prices:	Drug price information for QUILLIVANT XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUILLIVANT XR
DailyMed Link:	QUILLIVANT XR at DailyMed

See drug prices for QUILLIVANT XR

Recent Clinical Trials for QUILLIVANT XR

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

Sponsor	Phase
University of California, Davis	Phase 1
Matthew O'Brien	Phase 4
Matthew J O'Brien, PhD, BCBA-D	Phase 4

See all QUILLIVANT XR clinical trials

Pharmacology for QUILLIVANT XR

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Paragraph IV (Patent) Challenges for QUILLIVANT XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QUILLIVANT XR	Extended-release Oral Suspension	methylphenidate hydrochloride	5 mg/mL	202100		2013-08-02

US Patents and Regulatory Information for QUILLIVANT XR

QUILLIVANT XR is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes			Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes			Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes			Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes			Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes			Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes			Y

International Patents for QUILLIVANT XR

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

Country	Patent Number	Title	Estimated Expiration
Japan	5479086
Japan	2009530298
Brazil	PI0709606	formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica
South Korea	101495146
Denmark	2675438
Denmark	2428205

Market Dynamics and Financial Trajectory of Quillivant XR

Introduction

Quillivant XR, an extended-release liquid methylphenidate, has been a significant player in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) since its approval by the FDA in 2013. Here, we delve into the market dynamics and financial trajectory of this medication, highlighting its development, production issues, market expansion, and financial implications.

Development and Acquisition

Quillivant XR was initially developed by NextWave Pharmaceuticals, a specialty pharmaceutical company focused on ADHD treatments. In 2012, Pfizer Inc. announced its intention to acquire NextWave Pharmaceuticals, including the rights to Quillivant XR, for $255 million plus potential additional payments of up to $425 million based on sales milestones[2].

Market Entry and Initial Success

Upon its acquisition, Pfizer leveraged its commercialization expertise to introduce Quillivant XR as a new treatment option for ADHD patients. The drug quickly gained popularity due to its unique delivery system as the only extended-release liquid methylphenidate on the market, making it particularly beneficial for patients who have trouble swallowing or need full-day coverage[1].

Production Issues and Supply Shortages

Despite its initial success, Quillivant XR faced significant production issues and supply shortages. In late 2017, Pfizer reported supply disruptions, which continued into 2018. The shortage was partly resolved when Tris Pharma acquired the rights to Quillivant XR from Pfizer in September 2018. However, Tris Pharma also faced challenges in ensuring consistent supply, leading to regional shortages and inconsistent availability of certain strengths of the medication[1].

Transition to Tris Pharma

The transition from Pfizer to Tris Pharma was marked by efforts to address the supply issues. Tris Pharma, specializing in medications with unique delivery systems, worked diligently with wholesalers and distributors to ensure seamless availability of Quillivant XR. Despite these efforts, patients and caregivers continued to face challenges in obtaining the medication due to inconsistent messaging from pharmacists, prescribers, and the manufacturer[1].

Global Expansion

Tris Pharma has been instrumental in expanding the global availability of Quillivant XR. Recent regulatory approvals in countries such as Saudi Arabia, China, Israel, and Canada have broadened the international reach of the medication. This expansion is crucial given the rising global diagnosis rates of ADHD, estimated to affect approximately 129 million children and adolescents and over 366 million adults worldwide[4].

Financial Implications

The financial trajectory of Quillivant XR is closely tied to its market performance and production stability. The initial acquisition by Pfizer involved a significant upfront payment and potential milestone payments, indicating the drug's potential for high revenue. However, the production issues and subsequent supply shortages likely impacted the drug's financial performance during those periods.

With Tris Pharma's efforts to stabilize and expand the supply, the financial outlook for Quillivant XR has improved. The global expansion and increasing demand for ADHD treatments contribute to a positive financial trajectory. For instance, the regulatory approvals in new markets and the growing recognition of the need for long-acting ADHD therapies are expected to drive sales and revenue for Quillivant XR[4].

Market Competition

Quillivant XR operates in a competitive market with other methylphenidate options such as Ritalin, Concerta, and Daytrana. However, its unique liquid delivery system and extended-release profile set it apart, particularly for pediatric patients who have difficulty with traditional tablet or capsule forms. This differentiation helps maintain its market share and attractiveness to both prescribers and patients[1].

Safety and Adverse Reactions

While Quillivant XR has been effective, it is associated with common adverse reactions such as affect lability, excoriation, initial insomnia, and decreased appetite. Additionally, CNS stimulants like Quillivant XR can lead to weight loss and slowing of growth rate in pediatric patients, necessitating careful monitoring during treatment[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Quillivant XR. Regulatory approvals in new markets, such as the recent approval by the Saudi Food & Drug Authority, are essential for expanding the drug's global reach. Compliance with regulatory requirements and maintaining a robust safety profile are critical for sustaining market presence and financial stability[4].

Patient and Caregiver Impact

The availability and consistency of Quillivant XR have a direct impact on patients and caregivers. The drug's unique delivery system and extended-release profile make it a preferred option for many, especially those who struggle with traditional forms of ADHD medications. Efforts by Tris Pharma to address supply issues and expand availability have been crucial in ensuring that patients have consistent access to this medication[1].

Key Takeaways

• Unique Delivery System: Quillivant XR's extended-release liquid form sets it apart in the ADHD treatment market.
• Production Issues: Supply shortages have been a significant challenge, but Tris Pharma has been working to stabilize and expand supply.
• Global Expansion: Recent regulatory approvals have broadened the drug's international availability.
• Financial Trajectory: Despite initial production issues, the drug's financial outlook is positive due to global expansion and increasing demand.
• Market Competition: Quillivant XR competes with other methylphenidate options but maintains its market share due to its unique delivery system.
• Safety and Adverse Reactions: The drug is associated with common adverse reactions and requires careful monitoring, especially in pediatric patients.

FAQs

What is Quillivant XR used for?

Quillivant XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 and older. It is an extended-release liquid methylphenidate.

Why is Quillivant XR unique?

Quillivant XR is unique because it is the only extended-release liquid methylphenidate on the market, making it particularly beneficial for patients who have trouble swallowing or need full-day coverage.

What were the production issues with Quillivant XR?

The production issues with Quillivant XR included supply disruptions reported in late 2017, which continued into 2018. These issues persisted even after Tris Pharma acquired the rights to the medication from Pfizer.

How has Tris Pharma addressed the supply issues?

Tris Pharma has worked diligently with wholesalers and distributors to ensure seamless availability of Quillivant XR. They have also introduced a pharmacy locator service to help patients find their preferred medication.

What is the global reach of Quillivant XR?

Quillivant XR has recently received regulatory approvals in countries such as Saudi Arabia, China, Israel, and Canada, expanding its global availability to address the growing need for ADHD therapies worldwide.

What are the common adverse reactions associated with Quillivant XR?

Common adverse reactions include affect lability, excoriation, initial insomnia, tic, decreased appetite, vomiting, motion sickness, eye pain, and rash. Additionally, CNS stimulants like Quillivant XR can lead to weight loss and slowing of growth rate in pediatric patients.

Sources

1. Update on Quillivant XR Shortage: New Supply Coming to Market - ADDitude Magazine
2. Pfizer To Acquire NextWave Pharmaceuticals, Inc. - Pfizer
3. United States Securities and Exchange Commission - Form 10-Q - Pfizer
4. Tris Pharma Secures Additional ex-US Approvals to Expand Global Availability of Quillivant XR and QuilliChew ER for the Treatment of Attention Deficit Hyperactivity Disorder - Tris Pharma
5. Quillivant XR® (methylphenidate) ADHD Medication | Tris Pharma - Tris Pharma