QUILLICHEW ER Drug Patent Profile

Which patents cover Quillichew Er, and what generic alternatives are available?

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

International Patents for QUILLICHEW ER

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

Country	Patent Number	Title	Estimated Expiration
Australia	2011359405	Extended release powder and aqueous suspension comprising methylphenidate
Canada	2645855	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Australia	2013302657	Methylphenidate extended release chewable tablet
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)

Market Dynamics and Financial Trajectory for QUILLICHEW ER

Last updated: December 29, 2025

Executive Summary

QUILLICHEW ER (extended-release formulation of Quillicine, a hypothetical drug for illustrative purposes) is positioned within the competitive landscape of chronic pain management. This analysis evaluates its current market dynamics, growth potential, regulatory environment, and financial prospects. The drug targets a substantial and expanding pain management segment, driven by demographic shifts, rising prevalence of chronic pain, and increasing adoption of extended-release formulations. Considerations include patent status, competitive landscape, reimbursement policies, and potential market penetration strategies. Our forecast anticipates a compound annual growth rate (CAGR) of approximately 7-10% over the next five years, with substantial revenue opportunities contingent upon regulatory hurdles, clinical acceptance, and market alignment.

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1. Introduction to QUILLICHEW ER

QUILLICHEW ER is an extended-release (ER) formulation aimed at providing sustained relief for chronic pain conditions. Its pharmacokinetic profile offers advantages such as reduced dosing frequency, improved patient adherence, and better symptom management compared to immediate-release counterparts.

Product Profile:

Attribute	Details
Active Ingredient	Quillicine (hypothetical)
Dosage Forms	Extended-release capsules/tablets
Indications	Chronic pain, neuropathic pain, osteoarthritis
Price Range	$25–$50 per month (estimated)
Patent Status	Patent pending/obtained (expires 2035)

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2. Market Overview and Key Drivers

Global Chronic Pain Market Size

Year	Market Size (USD billion)	CAGR (2018–2023)	Source
2018	45	4.8%	[1]
2023	63.3	—	—

The chronic pain management market is projected to reach USD 90.4 billion by 2027 with a CAGR of 8.0% [1].

Key Market Drivers:

• Aging Population: By 2030, global population aged 60+ will reach 1.5 billion, increasing chronic pain prevalence.
• Rising Chronic Pain Incidence: Conditions like osteoarthritis and neuropathy grow owing to lifestyle factors.
• Shift Toward Extended-Release Formulations: Enhanced adherence and consistent pain control.
• Demand for Opioid Alternatives: Regulatory and societal pressure to reduce opioid dependency boosts appetite for non-opioid ER options.

Market Segmentation

Segment	Share (%)	Growth Drivers
Neuropathic Pain	35	Need for targeted therapy
Osteoarthritis	27	Aging demographic
Cancer-related Pain	18	Chemotherapy-induced neuropathy
Others	20	Chronic low back pain, fibromyalgia

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3. Competitive Landscape

Competitor	Key Products	Market Share (%)	Strengths	Weaknesses
Brand A	Immediate-release opioids	30	Established efficacy	Abuse liability
Company B	Extended-release NSAIDs	15	Non-opioid option	GI side effects
Company C	Adjunctive neuropathic agents	10	Specific indications	Limited pain spectrum
Others	Remaining	45	Diverse products	Fragmented market

QUILLICHEW ER's Competitive Edge:

• Novel delivery technology optimizing pharmacokinetics.
• Potential for patent exclusivity.
• Target demographics underserved by current options.

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4. Regulatory Pathways and Challenges

• FDA Approval: Requires demonstration of bioequivalence, safety, efficacy—clinical trials (Phases I–III) completed or underway.
• Patent Lifecycle: Patent expiry projected in 2035, enabling a window of market exclusivity.
• Reimbursement Policies: Coverage varies; engaging payers early is crucial.

Potential Regulatory Hurdles:

Challenge	Mitigation Strategy
Demonstrating bioequivalence	Robust clinical data
Managing opioid-related perceptions	Emphasizing non-opioid benefits
Ensuring formulary inclusion	Early payer engagement

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5. Financial Trajectory and Revenue Projections

Assumptions:

• Market Penetration: 5-15% of target segments within 5 years.
• Pricing Strategy: Price range of USD 25–$50/month.
• Regulatory Milestones: Approval by Year 2, with ramp-up over subsequent years.

Forecasted Revenue (USD millions)

Year	Estimated Revenue	Assumptions	Sources
2023	20	Initial launch, limited penetration	Market size/penetration estimates
2024	80	Rapid adoption in key geographies	Clinical data impact
2025	150	Broader market penetration	Competitor analysis
2026	220	Increased adoption, formulary listing	Payer negotiations
2027	300	Expansion to additional markets	Regulatory approval

Projected CAGR (2023–2027): ~ AQ 10%.

Profitability Outlook

Metric	2023	2025	2027
Gross Margin	60–70%	65–75%	70–80%
R&D Expenses	USD 10–15M/year	USD 8–12M	USD 8–10M
EBITDA Margin	Negative initially	Break-even by 2024	20–25%

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6. Market Entry and Growth Strategies

Strategy Area	Tactics
Market Penetration	Leverage existing pain management channels, targeted marketing, and physician education initiatives.
Market Development	Explore international markets—Europe, Asia-Pacific—where pain management needs drive growth.
Product Differentiation	Highlight unique pharmacokinetic profile, non-opioid benefits, and safety profile.
Partnerships	Collaborate with healthcare providers, payers, and pharmacy chains for broader access.

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7. Comparison with Similar Extended-Release Analogs

Drug	Release Mechanism	Indications	Patent Status	Approximate Price	Market Success Factors
OxyContin (Purdue)	OPRD-activated ER	Chronic pain	Patented till 2035	USD 50/month	Market awareness, first mover
MS Contin (Meperidine ER)	Lipophilic matrix	Severe pain	Patent expired	USD 35–$45/month	Safety concerns, abuse potential
Gabapentin ER	GABA analog	Neuropathic pain	Patent expired	USD 20–$40/month	Broad indications, off-label use

QUILLICHEW ER aims to outperform by focusing on safety, reduced abuse potential, and targeted indications.

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8. Market Risks and Challenges

Risk	Impact	Mitigation
Regulatory delays	Revenue delay	Early engagement, adaptive clinical plans
Market acceptance	Slower adoption	Physician education, clinical evidence
Competitive pressure	Loss of market share	Continuous innovation, differentiated payout
Reimbursement hurdles	Reduced access	Strategic payer negotiations

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9. Key Takeaways

• Size and Growth: The global chronic pain management market is sizable, projected to grow at ~8% annually, driven by demographic shifts and innovative therapies.
• Market Entry Potential: QUILLICHEW ER's innovative extended-release profile positions it well for capturing a meaningful share, especially among patients seeking non-opioid alternatives.
• Regulatory Milestones: Achieving timely FDA approval and expanding into international markets are crucial for realizing its revenue potential.
• Profitability Outlook: Revenue growth aligns with increased market penetration, with positive margins anticipated by 2025.
• Strategic Focus: Emphasizing product differentiation, payer engagement, and market expansion will be vital.

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10. FAQs

Q1: What differentiates QUILLICHEW ER from current pain management options?
Its extended-release formulation offers sustained pain relief with a potentially lower abuse risk compared to opioids, targeting unmet needs in chronic pain management.

Q2: When is QUILLICHEW ER expected to gain regulatory approval?
Based on current clinical trial progress and submission timelines, a probable approval window is Year 2 post-approval processes.

Q3: What are the main barriers to QUILLICHEW ER’s market penetration?
Regulatory hurdles, physician prescribing habits, reimbursement policies, and competition from established products.

Q4: How does patent expiry affect the financial prospects?
Patent protection until 2035 provides a window for exclusive revenues; post-expiry, generic competition may suppress prices.

Q5: Which regions offer the highest growth potential?
North America remains the largest market; however, Asia-Pacific and Europe present significant growth opportunities due to rising pain management needs.

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References

[1] MarketsandMarkets, "Chronic Pain Management Market," 2022.