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-seven 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:	2
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	92
Patent Applications:	4,500
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
Netherlands Institute for the Study of Crime	Phase 3
University of Geneva, Switzerland	Phase 3
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	021121-002	Aug 1, 2000
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000
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
Portugal	932388
European Patent Office	1083879	DISPOSITIFS SERVANT A MAINTENIR UN EFFET THERAPEUTIQUE PROLONGE (DEVICES FOR PROVIDING PROLONGED DRUG THERAPY)
Denmark	99784
Australia	9639101

CONCERTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Concerta

Overview of Concerta

Concerta, a brand name for the medication methylphenidate hydrochloride, is a central nervous system (CNS) stimulant used primarily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults up to the age of 65. It is formulated as extended-release tablets, capsules, or other oral administration forms[4].

Market Size and Growth

The Attention Deficit Hyperactivity Disorder (ADHD) drugs market, which includes Concerta, is projected to experience significant growth. From 2020 to 2025, the market is expected to increase by USD 9.61 billion, with an accelerated Compound Annual Growth Rate (CAGR) of 9.06%[1].

Regional Market Analysis

North America, particularly the US and Canada, is a key region for the ADHD drugs market, including Concerta. Although the growth rate in North America will be slower compared to Asia and Europe, it will still register a substantial growth rate of 40% among the other regions. The rise in parental attentiveness towards children with ADHD, along with the approval and commercialization of new drugs and an increase in clinical trials, will drive market growth in this region[1].

Drivers of Market Growth

Several factors are driving the growth of the ADHD drugs market, including Concerta:

• Rising Government Support: Increased government initiatives and funding for mental health and ADHD treatment are boosting the market.
• Approval and Commercialization of New Drugs: The approval of new medications and their subsequent commercialization are expanding treatment options and driving market growth.
• Increase in Clinical Trials: The rise in the number of clinical trials for ADHD treatments is contributing to the development of more effective medications and therapies[1].

Competitive Landscape

The ADHD drugs market is fragmented, with several key players competing for market share. Companies such as Johnson and Johnson Inc., Aurobindo Pharma Ltd., Aytu BioPharma Inc., Eli Lilly and Co., Glenmark Pharmaceuticals Ltd., Novartis AG, Purdue Pharma LP, SHIONOGI Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Tris Pharma Inc. are among the leading competitors in this market[1].

Financial Performance of Key Players

Johnson and Johnson, the manufacturer of Concerta, reported mixed results in Q3 2024. While their operational sales showed a 6.3% to 6.8% increase compared to the prior year, their net earnings and EPS (diluted) saw a decline of 37.5% and 34.3%, respectively. However, their adjusted operational sales, excluding COVID-19 vaccine sales, grew by 5.6%[5].

Pricing and Cost Dynamics

The cost of Concerta can vary significantly based on several factors:

• Dosage: Higher prescribed dosages result in higher costs.
• Geographical Location: Drug prices vary across regions due to local market conditions and regulatory differences.
• Pharmacy Location: Prices can differ between chain pharmacies, independent pharmacies, and online pharmacies.
• Health Insurance: Patients with comprehensive health insurance may face lower out-of-pocket costs compared to those without insurance[3].

Average Retail Cost

As of December 2024, the average retail cost of Concerta is approximately $599.86 per month, though this figure can fluctuate based on the aforementioned factors[3].

Patient Assistance Programs

Programs like The Rx Advocates offer fixed pricing structures for Concerta, such as $80 per month for a single medication, providing transparency and cost savings for patients[3].

Adverse Effects and Interactions

Concerta, like other CNS stimulants, can have adverse effects and interactions. Patients should start with the lowest dose and increase as necessary, and the medication should not be crushed or chewed. It is also important to monitor for potential side effects and drug interactions[3].

Off-Label Uses

Beyond its primary use in managing ADHD symptoms, Concerta has shown efficacy in addressing narcolepsy, a sleep disorder characterized by excessive daytime sleepiness, although this use is considered off-label[3].

Net Present Value Model

Evaluating the financial value of Concerta involves complex models that consider cash inflows and outflows, market dynamics, and the potential success rates for each stage of drug development. GlobalData provides detailed NPV models that leverage extensive market intelligence to assess the financial viability of drugs like Concerta[4].

Key Takeaways

• The ADHD drugs market, including Concerta, is expected to grow significantly with a CAGR of 9.06% from 2020 to 2025.
• North America is a key market, driven by increased parental attentiveness and government support.
• The competitive landscape is fragmented with multiple key players.
• Pricing varies based on dosage, location, and health insurance.
• Patient assistance programs can help reduce costs.
• Concerta has potential off-label uses, such as treating narcolepsy.

FAQs

Q: What is the projected growth rate of the ADHD drugs market from 2020 to 2025?

A: The ADHD drugs market is expected to grow at a CAGR of 9.06% from 2020 to 2025[1].

Q: Which region is expected to register the highest growth rate for ADHD drugs?

A: North America is expected to register the highest growth rate among the regions, with a significant contribution from the US and Canada[1].

Q: What factors influence the cost of Concerta?

A: The cost of Concerta is influenced by dosage, geographical location, pharmacy location, and health insurance coverage[3].

Q: Are there any patient assistance programs available for Concerta?

A: Yes, programs like The Rx Advocates offer fixed pricing structures to help patients save on the cost of Concerta[3].

Q: What are some potential off-label uses of Concerta?

A: Concerta has shown efficacy in addressing narcolepsy, a sleep disorder characterized by excessive daytime sleepiness, although this use is considered off-label[3].

Sources

1. Technavio: Attention Deficit Hyperactivity Disorder Drugs Market to Record 6.44% Y-O-Y Growth Rate in 2021 | Johnson and Johnson Inc. offers ADHD Drugs namely Concerta tablets[1].
2. Concentra Group Holdings Parent, Inc.: Concentra Group Holdings Parent, Inc. Announces Results For Its Third Quarter Ended September 30, 2024, and Cash Dividend[2].
3. The Rx Advocates: Concerta Coupon & Patient Assistance Programs[3].
4. GlobalData: Net Present Value Model: Concerta/Methylphenidate[4].
5. Johnson & Johnson: Johnson reports Q3 2024 results[5].