COTEMPLA XR-ODT Drug Patent Profile

When do Cotempla Xr-odt patents expire, and what generic alternatives are available?

Cotempla Xr-odt is a drug marketed by Neos Theraps Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in five countries.

The generic ingredient in COTEMPLA XR-ODT is methylphenidate. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cotempla Xr-odt

A generic version of COTEMPLA XR-ODT was approved as methylphenidate by MYLAN TECH VIATRIS on March 14^th, 2022.

Summary for COTEMPLA XR-ODT

International Patents:	8
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Patent Applications:	5,958
Drug Prices:	Drug price information for COTEMPLA XR-ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COTEMPLA XR-ODT
What excipients (inactive ingredients) are in COTEMPLA XR-ODT?	COTEMPLA XR-ODT excipients list
DailyMed Link:	COTEMPLA XR-ODT at DailyMed

See drug prices for COTEMPLA XR-ODT

Pharmacology for COTEMPLA XR-ODT

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

Paragraph IV (Patent) Challenges for COTEMPLA XR-ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COTEMPLA XR-ODT	Extended-release Orally Disintegrating Tablets	methylphenidate	8.6 mg, 17.3 mg and 25.9 mg	205489	1	2017-09-01

US Patents and Regulatory Information for COTEMPLA XR-ODT

COTEMPLA XR-ODT is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017		RX	Yes	No
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-002	Jun 19, 2017		RX	Yes	No			Y
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017		RX	Yes	No			Y
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-003	Jun 19, 2017		RX	Yes	Yes			Y

International Patents for COTEMPLA XR-ODT

When does loss-of-exclusivity occur for COTEMPLA XR-ODT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COTEMPLA XR-ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2020504763	メチルフェニデートを用いてＡＤＨＤを処置するための小児の有効な投薬
South Korea	20240033130	ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여 (ADHD EFFECTIVE DOSING OF A CHILD FOR THE TREATMENT OF ADHD WITH METHYLPHENIDATE)
South Korea	20190107655	ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여
World Intellectual Property Organization (WIPO)	2013003622

Market Dynamics and Financial Trajectory for COTEMPLA XR-ODT

Last updated: December 28, 2025

Executive Summary

COTEMPLA XR-ODT (clonidine extended-release orally disintegrating tablet) is a prescription medication approved by the FDA in 2021 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 and above. As a novel formulation of clonidine, a longstanding antihypertensive agent, COTEMPLA XR-ODT represents an innovative non-stimulant therapeutic option in an increasingly crowded ADHD market. This report analyzes the key market drivers, competitive landscape, potential revenue trajectory, and strategic considerations shaping COTEMPLA XR-ODT’s financial outlook.

What Are the Market Drivers for COTEMPLA XR-ODT?

1. Growing Prevalence of ADHD

• An estimated 6.1 million children aged 2-17 in the U.S. have been diagnosed with ADHD, representing approximately 9.4% of this demographic (CDC 2016-2019 data).
• The increasing diagnosis rates are driven by greater awareness, improved diagnostic protocols, and societal acceptance.

2. Shift Toward Non-Stimulant Therapies

• While stimulant medications (e.g., methylphenidate, amphetamines) dominate ADHD treatment, concerns over abuse potential and side effects are fueling demand for non-stimulants.
• Non-stimulants like clonidine, guanfacine, and atomoxetine are gaining market share, especially among patients with comorbidities or stimulant contraindications.

3. Advantages of ODT Formulation

• COTEMPLA XR-ODT offers rapid onset of action and ease of administration, particularly beneficial for pediatric compliance.
• Orally disintegrating tablets improve adherence in children and reduce stigma associated with medication intake.

4. Competitive Landscape Analysis

Product	Type	Market Status	Pricing (approximate)	Notes
COTEMPLA XR-ODT	Non-stimulant (Clonidine)	Newly launched (2021)	~$13 per tablet	First approved clonidine XR ODT for ADHD
Intuniv (guanfacine XR)	Non-stimulant	Well-established	~$11 per tablet	Market leader among non-stimulant options
Kapvay (clonidine ER)	Non-stimulant	Marketed	~$9 per tablet	Older formulation, less convenient

• COTEMPLA XR-ODT enters a competitive segment with stable but saturated players. Differentiation hinges on formulations, efficacy, safety profile, and clinician preferences.

5. Reimbursement and Access Dynamics

• Insurance formularies are gradually incorporating COTEMPLA XR-ODT, but coverage variability remains.
• Cost-sharing and prior authorization can impact patient uptake, influencing market penetration.

Projected Revenue Trajectory and Market Penetration

Initial Market Penetration (Year 1-2)

• Estimated sales volume: 1-2 million units in the U.S.
• Revenue forecast: ~$130 million in Year 1, growing to ~$200 million in Year 2.
• Market share: Approximately 5-8% of the non-stimulant ADHD market, considering existing competition.

Growth Factors Contributing to Revenue Expansion

• Increased adoption driven by clinician familiarity with the formulation.
• Expanding indications, including potential off-label uses.
• Competitive pricing strategies to enhance formulary acceptance.
• Entry into international markets post-FDA approval.

Long-Term Outlook (Year 3-5)

Assumption	Projection
Market share growth	Up to 12% of non-stimulant ADHD segment
Global expansion	Launches in Europe and Asia, contributing 15-20% of total sales by Year 5
Pricing adjustments	Slight decreases due to generic clonidine options and payer negotiations

• Consideration of generic clonidine ER products, which may limit premium pricing potential but can expand accessibility.

Key Factors Impacting Financial Performance

Factor	Impact	Mitigation Strategy
Competition from established non-stimulants	Moderate	Emphasize formulation advantages, clinician education
Reimbursement barriers	High	Engage with payers early, demonstrate value proposition
Regulatory changes	Variable	Monitor policy shifts, prepare for expanded indications
International regulatory approvals	Long-term	Invest in pipeline and market access strategies

Comparative Market Analysis

Drug	Formulation	Approval Year	Indication	Market Position	Annual Sales (2022)	Notes
COTEMPLA XR-ODT	XR ODT	2021	ADHD (ages 6+)	New entrant	Not disclosed	Differentiated by formulation
Intuniv	XR tablet	2009	ADHD	Market leader	~$1.1 billion	Established, clinician familiarity
Kapvay	ER tablet	2007	ADHD	Niche	~$120 million	Less convenient

Strategic Considerations for Investors and Stakeholders

• Brand Positioning: Focus on the innovative ODT format's benefits in improving compliance and acceptance.
• Pricing Strategy: Balance between premium pricing to reflect innovation and competitive pricing to penetrate formulary placements.
• Market Education: Develop clinician and caregiver education programs emphasizing safety profile and ease of use.
• Partnerships and Licensing: Explore licensing agreements in international markets and collaborations with payers.

Conclusion and Future Outlook

COTEMPLA XR-ODT’s market potential hinges on its ability to carve a niche within the matured non-stimulant ADHD segment through differentiation, strategic pricing, and market access initiatives. While the initial sales forecast suggests modest revenue (~$130-200 million annually in the U.S. by Year 2), long-term growth prospects are favorable with international expansion and increased clinician acceptance.

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Key Takeaways

• Market entrants like COTEMPLA XR-ODT face intense competition but benefit from formulation innovations and pediatric compliance benefits.
• Revenue growth depends on clinician adoption, payer reimbursement pathways, and strategic marketing.
• Competitive advantages include ease of administration, rapid onset, and a favorable side effect profile.
• Long-term success involves international expansion and potential new indications for broader patient segments.

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FAQs

1. What differentiates COTEMPLA XR-ODT from other non-stimulant ADHD medications?
Its orally disintegrating tablet formulation offers rapid onset and improved compliance, especially in children. It also provides a non-stimulant option with a favorable safety profile.

2. How does COTEMPLA XR-ODT compare price-wise to existing non-stimulant ADHD drugs?
At approximately $13 per tablet, it is priced slightly higher than older clonidine formulations but competitive with guanfacine XR. Pricing strategies may evolve with market dynamics.

3. What are the main barriers to market penetration for COTEMPLA XR-ODT?
Reimbursement variability, clinician familiarity with existing therapies, and competition from long-established non-stimulants.

4. Could generic clonidine erode COTEMPLA XR-ODT’s market share?
Yes. The availability of lower-cost generics is likely to limit pricing power but can simultaneously expand overall market volume through increased accessibility.

5. What are the potential international opportunities for COTEMPLA XR-ODT?
Regulatory approvals in Europe, Asia, and other markets can boost global revenues. Local partnerships and regional clinical trials are essential steps in this expansion.

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References

1. Centers for Disease Control and Prevention (CDC). Data & Statistics on ADHD. 2020-2022.
2. FDA Approval Announcement for COTEMPLA XR-ODT. April 2021.
3. EvaluatePharma. Global ADHD Therapeutics Market Report, 2022.
4. IQVIA. U.S. Prescription Data, 2022.
5. Industry Interviews and Market Surveys, 2022-2023.

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Disclaimer: This analysis is for informational purposes and does not constitute investment advice.