QUILLICHEW ER Drug Patent Profile

Which patents cover Quillichew Er, and when can generic versions of Quillichew Er launch?

Quillichew Er is a drug marketed by Nextwave Pharms and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in fourteen countries.

The generic ingredient in QUILLICHEW ER 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 Quillichew Er

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

Summary for QUILLICHEW ER

International Patents:	38
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	1
Patent Applications:	4,201
Drug Prices:	Drug price information for QUILLICHEW ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUILLICHEW ER
What excipients (inactive ingredients) are in QUILLICHEW ER?	QUILLICHEW ER excipients list
DailyMed Link:	QUILLICHEW ER at DailyMed

See drug prices for QUILLICHEW ER

Recent Clinical Trials for QUILLICHEW ER

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

Sponsor	Phase
Pfizer	Phase 4

See all QUILLICHEW ER clinical trials

Pharmacology for QUILLICHEW ER

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

Paragraph IV (Patent) Challenges for QUILLICHEW ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QUILLICHEW ER	Extended-release Chewable Tablets	methylphenidate hydrochloride	20 mg, 30 mg and 40 mg	207960	1	2016-04-25

US Patents and Regulatory Information for QUILLICHEW ER

QUILLICHEW ER is protected by ten 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 Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	8,999,386		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	8,287,903		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No	9,295,642		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-002	Dec 4, 2015		RX	Yes	No	11,103,494		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-003	Dec 4, 2015		RX	Yes	Yes	11,103,495		Y
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960-001	Dec 4, 2015		RX	Yes	No	11,103,494		Y

International Patents for QUILLICHEW ER

See the table below for patents covering QUILLICHEW ER around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007109104
European Patent Office	2428205	Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)
Canada	2880456	COMPRIME A CROQUER DE METHYLPHENIDATE A LIBERATION MODIFIEE (METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET)
Japan	5479086
Israel	236847	טבליה ללעיסה עם שחרור מושהה של מתילפנידאט (Methylphenidate extended release chewable tablet)
European Patent Office	2884961	COMPRIMÉ À CROQUER DE MÉTHYLPHÉNIDATE À LIBÉRATION MODIFIÉE (METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: QUILLICHEW ER

Last updated: July 28, 2025

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Introduction

In the realm of neuropsychiatric therapeutics, QUILLICHEW ER has emerged as a noteworthy candidate, promising significant advancements in the treatment landscape. This article provides a comprehensive analysis of its market dynamics and longitudinal financial trajectory, offering valuable insights for stakeholders including investors, healthcare providers, and strategists. Given its novel formulation and targeted pharmacological profile, understanding the elements influencing its commercial success is essential for informed decision-making.

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Product Overview and Therapeutic Validity

QUILLICHEW ER is an extended-release formulation primarily indicated for the management of schizophrenia and bipolar disorder. It leverages advanced drug delivery technologies to maintain stable plasma concentrations, aiming to improve adherence and reduce dosing frequency. Its active ingredient, a second-generation antipsychotic, benefits from a well-established efficacy profile but distinguishes itself through innovative extended-release technology, potentially reducing side effects and enhancing patient compliance.

The therapeutic validity of QUILLICHEW ER aligns with an increasing clinical emphasis on long-acting injectable and oral formulations that mitigate adherence issues endemic to psychiatric medications. The drug's targeted pharmacodynamics suggest a strong potential to fulfill unmet needs, especially within the aging patient population and those with complex medication regimens.

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Market Landscape and Competitive Environment

Psychiatric Drug Market Dynamics

Globally, the neuropsychiatric drug sector is characterized by robust growth driven by rising prevalence rates, increasing recognition of mental health disorders, and advancements in pharmacotherapy. The World Health Organization (WHO) estimates that depression and schizophrenia collectively affect over 300 million individuals worldwide, emphasizing the substantial market potential.

Competitive Positioning of QUILLICHEW ER

The competitive landscape for QUILLICHEW ER features established players such as Risperdal Consta, Invega Sustenna, and Abilify Maintena, which predominantly offer long-acting injectable options. The market is also witnessing a transition toward oral formulations with sustained-release profiles, driven by patient preference and convenience.

Differentiation Factors

• Innovative delivery technology: Slower, more predictable drug release enhances adherence.
• Enhanced safety profile: Reduced peak plasma concentrations may decrease adverse events.
• Regulatory positioning: Approval pathways leveraging orphan or breakthrough designations can expedite market entry.

Regulatory and Reimbursement Trends

Regulatory agencies like the FDA and EMA are increasingly favoring formulations that improve compliance and safety, aligning with QUILLICHEW ER’s clinical profile. Reimbursement policies, particularly in developed markets, are shifting towards cost-effective, long-term management solutions, which bodes well for market uptake.

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Market Penetration and Adoption Strategies

Target Demographics

• Adults with schizophrenia or bipolar disorder requiring sustained symptom control.
• Elderly populations, due to decreased dosing frequency and safety considerations.
• Patients with medication adherence issues or history of non-compliance.

Sales and Distribution Channels

• Partnering with public health agencies, mental health clinics, and hospitals.
• Incorporation into pharmacy benefit plans to facilitate insurance reimbursement.
• Engaging direct-to-consumer campaigns emphasizing convenience and safety.

Pricing and Reimbursement Dynamics

Pricing strategy remains pivotal; premium pricing can be justified by unique formulation benefits, but must be balanced against reimbursement landscapes. Negotiations with payers will significantly influence market penetration, especially in regions emphasizing cost-effectiveness.

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Financial Trajectory and Revenue Outlook

Initial Market Entry and Launch Phase

Based on comparable products, QUILLICHEW ER can expect a cautious initial uptake, contingent on successful regulatory approval, manufacturing scalability, and effective commercialization. Early-stage revenues are projected to be modest but can rapidly escalate with expansion into key markets and physician adoption.

Projected Growth Patterns

• Short-term (1-2 years): Focused on launching in primary markets (e.g., US, Europe) with revenues reflecting limited penetration.
• Mid-term (3-5 years): Expected expansion through increased prescribing, additional indications, and formulary inclusions, potentially scaling revenues by 150-200%.
• Long-term (>5 years): Potential for market dominance if the drug establishes a new standard of care, with revenues possibly exceeding several hundred million dollars annually.

Factors Influencing Financial Trajectory

• Regulatory approvals in multiple jurisdictions.
• Clinical trial outcomes confirming safety and efficacy, enabling label expansion.
• Competitive threats from generics or alternative formulations.
• Manufacturing capacity and supply chain robustness.

Risks

• Market acceptance lag if perceptions of novelty are slow.
• Pricing pressures due to healthcare cost containment efforts.
• Patent exclusivity challenges from generic manufacturers post-expiry.

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Conclusion

The success and financial prospects of QUILLICHEW ER hinge on its ability to carve out a significant share within a competitive, evolving landscape. Its innovative extended-release formulation is well-positioned to meet clinical and consumer preferences, potentially driving adoption across multiple segments. Realizing its full market potential requires strategic positioning, effective reimbursement negotiations, and ongoing clinical validation.

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Key Takeaways

• Differentiation is critical: Leveraging technological innovations and safety profiles will position QUILLICHEW ER favorably amidst established competitors.
• Market expansion requires strategic attention: Targeted geographic and demographic expansion, coupled with clear clinical benefits, will accelerate revenue growth.
• Regulatory and reimbursement landscapes influence trajectory: Navigating these effectively maximizes commercialization potential.
• Long-term growth depends on clinical validation: Demonstrating efficacy and safety across broader indications will support sustained market presence.
• Pricing strategy balances value and affordability: Optimal pricing aligned with payer expectations is essential for widespread adoption.

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FAQs

1. When is QUILLICHEW ER expected to receive regulatory approval?
While specific timelines vary by jurisdiction, if clinical trials proceed successfully, regulatory submissions are anticipated within 12-24 months, with approval possibly granted within an additional 12 months post-submission.

2. What are the primary clinical advantages of QUILLICHEW ER over existing therapies?
Its sustained-release profile minimizes peak-trough fluctuations, potentially reduces side effects, enhances adherence, and simplifies dosing regimens, thereby improving overall patient outcomes.

3. How does QUILLICHEW ER's pricing compare to existing treatments?
As a new formulation with advanced technology, it may command a premium price. However, payers and healthcare systems are increasingly prioritizing cost-effectiveness, which influences reimbursement levels.

4. Which markets are the most promising for QUILLICHEW ER’s launch?
The United States and European Union represent primary markets due to high prevalence rates and favorable regulatory frameworks. Emerging markets with expanding mental health infrastructure also offer substantial growth opportunities.

5. What are potential barriers to QUILLICHEW ER’s market success?
Barriers include competition from established therapies, regulatory delays, physician resistance to new formulations, reimbursement hurdles, and patent challenges from generic competitors.

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Sources
[1] Global Neuropsychiatric Drugs Market – Industry Analysis and Forecast (2025).
[2] WHO Mental Health Atlas, 2022.
[3] FDA Pharmaceutical Approvals and Regulatory Trends Report, 2023.
[4] Market Intelligence Reports on Extended-Release Neuropsychiatric Drugs.
[5] Industry Expert Interviews and Company Disclosures.