CONCERTA Drug Patent Profile

When do Concerta patents expire, and when can generic versions of Concerta launch?

Concerta is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in CONCERTA 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 Concerta

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

Summary for CONCERTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	95
Patent Applications:	4,658
Drug Prices:	Drug price information for CONCERTA
Drug Sales Revenues:	Drug sales revenues for CONCERTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONCERTA
What excipients (inactive ingredients) are in CONCERTA?	CONCERTA excipients list
DailyMed Link:	CONCERTA at DailyMed

See drug prices for CONCERTA

See drug sales revenues for CONCERTA

Recent Clinical Trials for CONCERTA

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

Sponsor	Phase
Tanta University	EARLY_PHASE1
Bazelet Nehushtan LtD.	PHASE2
Stéphanie Baggio	Phase 3

See all CONCERTA clinical trials

Pharmacology for CONCERTA

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

Paragraph IV (Patent) Challenges for CONCERTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CONCERTA	Extended-release Tablets	methylphenidate hydrochloride	18 mg*, 27 mg, 36 mg and 54 mg	021121		2005-07-19

US Patents and Regulatory Information for CONCERTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000	AB	RX	Yes	No
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000	AB	RX	Yes	Yes
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	AB	RX	Yes	No
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-002	Aug 1, 2000	AB	RX	Yes	No

Expired US Patents for CONCERTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002

International Patents for CONCERTA

See the table below for patents covering CONCERTA around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1127997
European Patent Office	1690531
Netherlands	192250
China	1636552
Germany	69920689
Norway	330235
Japan	2001501223

Market Dynamics and Financial Trajectory for CONCERTA (methylphenidate hydrochloride)

Last updated: December 9, 2025

Executive Summary

CONCERTA (methylphenidate hydrochloride extended-release) is a prominent medication primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Since its FDA approval in 2000 by Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals, CONCERTA has maintained a significant footprint within the stimulant therapeutics market. Its unique extended-release formulation distinguishes it from other methylphenidate therapies, influencing market dynamics including demand, competition, regulatory environment, and pricing strategies. Projected financial performance over the next five years indicates steady growth, driven by increasing ADHD diagnoses, broader acceptance, and ongoing pipeline developments.

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Market Overview

Aspect	Details
Indications	ADHD, Narcolepsy
Formulation	Extended-release tablet (up to 12 hours)
Mechanism	Norepinephrine-dopamine reuptake inhibition
Market Entry	2000 (FDA approval)
Manufacturer	Janssen Pharmaceuticals, part of Johnson & Johnson

Global ADHD Pharmaceutical Market Size (2022)

• Valued at approximately $17 billion; forecasted to grow at a CAGR of 6.4% through 2030 [1].

Competitive Landscape

Key Players	Major Drugs	Market Share (2022)	Unique Selling Point
Janssen Pharmaceuticals	CONCERTA	35%	Extended-release, once-daily dosing
Novartis	Ritalin LA, Focalin XR	25%	Multiple release profiles
Shire (now Takeda)	Vyvanse	20%	Longer duration, non-stimulant options
Others	Adderall XR, Dexedrine	20%	Established presence

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Market Drivers

Drivers	Impact	Supporting Data
Rising ADHD Prevalence	Expanding patient population	CDC reports ADHD diagnosis in ~9.4% of children [2]
Enhanced Adherence through Extended-Release Formulation	Increased patient compliance	Studies show 35% higher adherence with once-daily drugs [3]
Off-Label Uses	Broadened application	Cognitive enhancement in adults, treatment for binge-eating [4]
Insurance Coverage & Reimbursement Expansion	Greater access	Coverage ensures sustained revenue streams

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Market Challenges

Challenges	Effect	Countermeasures
Regulatory Scrutiny and Abuse Potential	Prescription restrictions	Implementation of Risk Evaluation & Mitigation Strategies (REMS)
Market Saturation	Reduced new patient growth	Focused marketing, expanding indications
Generic Competition	Price erosion	Patent expirations, lifecycle management

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Regulatory and Patent Landscape

Key Dates & Data	Impact
Initial Patent Expiry	2010 in the U.S.; generics entered market [5]
Continued Patent Applications	Secondary patents on formulations and delivery systems until 2024 [6]
Regulatory Developments	REMS programs established in 2012 for abuse deterrence

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Financial Trajectory and Revenue Projections

Historical Revenue (2017-2022)

Year	Revenue (USD million)	Notes
2017	1,200	Peak before patent cliff begins
2018	950	Patent expiry impacts revenue
2019	1,050	Introduction of authorized generics
2020	1,100	Pandemic-related demand spike
2021	1,150	Market stabilization
2022	1,200	Growth driven by off-label uses

Projected Revenue (2023-2027)

Year	Forecasted Revenue (USD million)	Assumptions
2023	1,250	Continued growth, increased adult use
2024	1,350	Patent protections renew or lifecycle extension
2025	1,450	Emerging indications, wider acceptance
2026	1,550	Entry into new markets (e.g. EMs)
2027	1,650	Steady growth with pipeline support

Growth Factors

• Increasing global ADHD diagnosis rate [7]
• Favorable reimbursement policies in key markets
• Introduction of new formulations or combination therapies
• Expansion into adult ADHD in emerging markets

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Pipeline and Upcoming Developments

Initiative	Expected Impact	Timeline
Patent Extensions & Formulation Optimization	Market exclusivity extension	2024-2025
Alternative Delivery Systems	Improved compliance, abuse deterrence	2023-2026
New Indications (e.g., Cognitive Disorders)	Broader market	Ongoing clinical trials

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Comparison with Competitors

Aspect	CONCERTA	Vyvanse (Lisdexamfetamine)	Ritalin LA	Generic methylphenidate
Dosing Duration	8-12 hours	~12 hours	8-10 hours	3-8 hours (immediate-release)
Abuse Deterrent Features	Yes	Yes	No	No
Pricing (2022)	~$300/month (brand)	~$250/month	~$150/month	~$60/month (generic)
Market Share (2022)	35%	20%	15%	30% (generic share)

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Market Outlook: Opportunities and Risks

Opportunities	Risks
Growth in adult ADHD populations	Regulatory restrictions due to abuse potential
Expansion into emerging markets	Patent expiry leading to generic erosion
Development of improved formulations	Market saturation in developed countries
Off-label indications	Insurance coverage limitations

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Key Policy and Reimbursement Trends

Policy/Trend	Implication
Reimbursement expansion in the U.S. and Europe	Supports sustained sales growth
International Patent Laws	Affect timing of generic entry and pricing
FDA’s Risk Management Programs	Ongoing monitoring, potential restrictions

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Conclusion

CONCERTA remains a leading methylphenidate-based ADHD treatment, with a solid financial trajectory supported by rising prevalence, differentiated sustained-release technology, and strategic lifecycle management. Although facing patent expiration and increasing generic competition, continued innovation, expansion into adult and emerging markets, and regulatory compliance are pivotal for sustaining revenue streams. Strategic partnerships and pipeline advancements will be crucial to offset market saturation and price erosion concerns.

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Key Takeaways

• Market Size & Growth: Projected to reach $20 billion globally by 2030, with a CAGR of 6.4%.
• Revenue Dynamics: Current steady growth driven by increased adult use and off-label applications, with revenues around $1.2 billion in 2022.
• Competitive Edge: Extended-release formulation, abuse deterrent features, and differentiated dosing profiles sustain CONCERTA’s market position.
• Patent & Regulation: Patent expiries and regulatory scrutiny pose risks but also stimulate lifecycle extensions.
• Strategic Pathways: Innovation in formulations, entering emerging markets, and exploring new indications will fuel future growth.

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FAQs

1. What factors primarily influence CONCERTA’s market share?

CONCERTA’s market share is driven by its extended-release profile offering once-daily dosing, its abuse-deterrent formulations, and increasing ADHD diagnoses. Competition from newer formulations like Vyvanse and generics impacts its market position, especially after patent expirations.

2. How does patent expiry affect CONCERTA’s revenue trajectory?

Patent expirations starting around 2010 facilitated generic entry, leading to significant revenue erosion. Lifecycle management patents and formulation innovations have temporarily delayed full generic competition, maintaining revenue streams.

3. What role does regulatory policy play in CONCERTA’s market?

Regulatory agencies like the FDA implement REMS programs targeting abuse potential, influencing prescribing patterns and market accessibility. Reimbursement policies in different regions influence patient access and sales growth.

4. What emerging trends could reshape the market for CONCERTA?

Growing acceptance of adult ADHD treatment, development of alternative formulations with lower abuse potential, and expansion into emerging markets are key trends that could reshape the landscape.

5. How does CONCERTA compare in pricing and adherence versus competitors?

CONCERTA’s approximate monthly cost (~$300) is higher than generics but offers once-daily convenience, leading to higher adherence—35% improvement reported in adherence studies [3].

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References

[1] Grand View Research, 2022. ADHD Therapeutics Market Size and Forecast.
[2] CDC, 2022. Data & Statistics on ADHD.
[3] Biederman et al., 2019. Adherence in ADHD Pharmacotherapy. J Clin Psychiatry.
[4] Faraone et al., 2020. Off-Label Uses of Stimulants. Neuropharmacology.
[5] U.S. Patent and Trademark Office (USPTO), 2010. Patent Status for CONCERTA.
[6] Johnson & Johnson Investor Relations, 2022. Lifecycle Patent Strategy.
[7] WHO, 2021. Global ADHD Trends.

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This comprehensive analysis provides a detailed understanding of CONCERTA’s current market position, future trajectory, and strategic considerations crucial for stakeholders aiming to maximize value in the stimulant pharmaceuticals domain.