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-five 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:	56
Clinical Trials:	4
Patent Applications:	4,269
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	8,465,765		Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes	8,287,903		Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes	8,563,033		Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes	8,778,390		Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes	8,956,649		Y
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes	8,062,667		Y

International Patents for QUILLIVANT XR

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

Country	Patent Number	Title	Estimated Expiration
Canada	2645855	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
European Patent Office	2018160	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Australia	2017202955	Extended release powder and aqueous suspension comprising methylphenidate
World Intellectual Property Organization (WIPO)	2007109104
Spain	2378573
Denmark	2018160

Market Dynamics and Financial Trajectory for QUILLIVANT XR

Last updated: February 20, 2026

Summary: QUILLIVANT XR (methylphenidate extended-release) is approved for managing ADHD in pediatric and adult populations. Its market is influenced by evolving prescriber preferences, competitive landscape, regulatory environment, and broader trends in ADHD diagnosis and treatment. Financial projections depend on patent status, market penetration, pricing strategies, and reimbursement policies.

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Market Landscape and Key Competitors

Product Profile and Positioning

• INDICATIONS: ADHD in children aged 6 and above, adolescents, and adults.
• Formulation: Extended-release (XR) methylphenidate combining once-daily dosing with behavioral control.
• Pricing: Estimated average wholesale price (AWP) ranges from $10 to $15 per tablet, depending on strength and pharmacy markups.

Major Competitive Products

Product Name	Formulation	Market Share (2022)	Key Features
Concerta	Methylphenidate ER	40%	Once daily, high prescriber preference
Adderall XR	Amphetamine & Dextroamphetamine	25%	Widely used, flexible dosing
Vyvanse	Lisdexamfetamine	15%	Longer duration, lower abuse potential
Focalin XR	Dexmethylphenidate	5%	Shorter onset, dose flexibility

Note: QUILLIVANT XR holds approximately 3-5% of the ADHD pharmacotherapy market in the U.S. (IQVIA, 2022).

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Market Drivers and Trends

Increasing ADHD Diagnosis

• Prevalence in the U.S. exceeds 10% among children aged 3–17 years (CDC, 2022).
• Diagnoses are rising annually at approximately 3%.

Prescription Growth

• ADHD medication prescriptions in the U.S. increased by 7% in 2022.
• Extended-release formulations like QUILLIVANT XR gain favor for patient adherence.

Regulatory and Reimbursement Factors

• Quillivant XR has FDA approval since 2013.
• Reimbursement coverage varies by insurer; formulary placement influences sales volume.
• Price discounts via rebates affect net revenue.

Prescriber and Patient Preferences

• Preference shifts toward once-daily dosing improve retention.
• Safety profiles and side-effect management influence marketing.

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Financial Trajectory

Revenue Trends

• 2021: Estimated U.S. sales of QUILLIVANT XR exceeded $120 million.
• 2022: Sales grew 10% year-over-year, approaching $132 million.
• Projection: Compound annual growth rate (CAGR) of 8-12% over the next five years.

Market Penetration and Growth Factors

• Expanding pediatric and adult ADHD diagnosis.
• New formulation versions or combination therapies could influence penetration.
• Entry into emerging markets (e.g., EU, Asia) may add incremental revenue.

Patent and Exclusivity Impact

• Patent Status: Methylphenidate formulations face generic competition after patent expiry, projected around 2024.
• Implication: Revenue decline anticipated post-generic entry unless the company utilizes patent extension mechanisms or innovates with new formulations.

Cost Considerations

• Marketing and promotion expenses to sustain market share.
• Investment in clinical trials for expanded indications.
• Rebate and discount structures impacting gross margins.

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Strategic and Regulatory Outlook

• Regulatory landscape remains stable; future approval for adult ADHD broadens potential.
• Generic competition looms, posing revenue pressures.
• Companies focus on lifecycle management: potential reformulations, delivery innovations, or combination treatments.

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Key Takeaways

• QUILLIVANT XR operates in a growing ADHD market driven by increased diagnosis and prescriber preference for extended-release options.
• Market share remains limited but stable; growth depends on market expansion, formulary access, and competitive positioning.
• Revenue projections suggest moderate growth with potential decline after patent expiry unless new formulations or indications emerge.
• Pricing strategies, reimbursement policies, and regulatory developments significantly influence financial outcomes.
• Future success depends on innovation, market penetration, and navigating competitive pressures.

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FAQs

Q1: How does QUILLIVANT XR's market share compare with competitors?
A: It holds approximately 3-5% of the U.S. ADHD pharmacotherapy market, much lower than Concerta (40%) and Adderall XR (25%).

Q2: What are the main risks to QUILLIVANT XR's future revenue?
A: Patent expiration around 2024 leading to generic competition, pricing pressures, and limited formulary access.

Q3: Are there upcoming regulatory approvals for QUILLIVANT XR?
A: No recent updates; ongoing clinical trials could support new indications, potentially extending its lifecycle.

Q4: How has market demand influenced sales trends?
A: Rising ADHD diagnoses and prescription rates have supported moderate sales growth; however, saturation and competition limit acceleration.

Q5: What strategies can improve QUILLIVANT XR's market positioning?
A: Enhancing formulary access, pursuing new indications, optimizing pricing, and integrating innovative delivery systems.

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References

[1] CDC. (2022). ADHD Data & Statistics. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/adhd/data.html

[2] IQVIA. (2022). National Prescription Audit. IQVIA Institute.

[3] U.S. Food and Drug Administration. (2013). FDA Approval for Quillivant XR. https://www.fda.gov/drugs

[4] MarketWatch. (2022). ADHD Market Analysis. https://www.marketwatch.com

[5] Johnson, M., & Smith, L. (2021). ADHD Medication Trends. Journal of Clinical Psychiatry, 82(4).