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	11,166,947
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-002	Jun 19, 2017		RX	Yes	No	8,840,924		Y
Neos Theraps Inc	COTEMPLA XR-ODT	methylphenidate	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	205489-001	Jun 19, 2017		RX	Yes	No	8,840,924		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
South Korea	20190107655	ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여
European Patent Office	3585439	DOSAGE EFFICACE D'UN ENFANT POUR LE TRAITEMENT DU TDAH AVEC DU MÉTHYLPHÉNIDATE (EFFECTIVE DOSING OF A CHILD FOR THE TREATMENT OF ADHD WITH METHYLPHENIDATE)
Australia	2017353921	Effective dosing of a child for the treatment of ADHD with methylphenidate

Market Dynamics and Financial Trajectory for COTEMPLA XR-ODT

Last updated: July 28, 2025

Introduction

COTEMPLA XR-ODT (clonidine extended-release tablets orally disintegrating tablets) is an innovative pharmacological product designed for the management of Attention Deficit Hyperactivity Disorder (ADHD). Developed by Supernus Pharmaceuticals, Inc., COTEMPLA XR-ODT combines a well-established active ingredient with a novel delivery platform, positioning it as a potential disruptor in the ADHD therapeutic landscape. Analyzing its market dynamics and projecting its financial trajectory requires an in-depth review of current market forces, product positioning, competitive landscape, regulatory considerations, and broader healthcare trends.

---

Market Overview

Global ADHD Market

The ADHD treatment market has experienced rapid growth over the past decade, fueled by increased diagnosis rates, expanded awareness, and the development of diverse therapeutics. According to Fortune Business Insights, the global ADHD market was valued at approximately USD 16.8 billion in 2021 and is projected to reach USD 33.9 billion by 2028, with a CAGR of around 10% [1]. North America dominates this market segment, accounting for nearly 70% of sales, driven by high prevalence rates and robust healthcare infrastructure.

Key Market Drivers

• Increasing Diagnosis Rates: DSM-5 criteria and lowered age thresholds have expanded diagnostic rates, especially among children and adolescents. Adult ADHD diagnosis is also rising, further enlarging the market.

• Product Innovation & Compliance: Extended-release and orally disintegrating formulations like COTEMPLA XR-ODT target patient compliance by improving ease of administration, especially for children with swallowing difficulties.

• Growing Awareness & Healthcare Spending: Campaigns emphasizing early diagnosis and treatment, combined with higher healthcare expenditure, support market expansion.

Regulatory Environment

The FDA’s accelerated review pathways, coupled with orphan drug designations for some ADHD formulations, facilitate quicker market entry for newer drugs like COTEMPLA XR-ODT. Moreover, patent protections and exclusivities are critical to safeguarding revenue streams.

---

Market Dynamics Influencing COTEMPLA XR-ODT

1. Innovation & Differentiation

COTEMPLA XR-ODT’s unique oral disintegration platform offers rapid onset, convenience, and improved adherence. Compared to traditional tablets and capsules, the orally disintegrating format captures patient preferences, especially in pediatrics. Its delivery system, utilizing novel technology (e.g., ODT formulation), positions COTEMPLA by filling gaps in patient-centric therapies.

2. Competitive Landscape

The ADHD therapeutics market is highly competitive, comprising established giants such as Shire (now part of Takeda), Johnson & Johnson, and Eli Lilly, alongside newer entrants and generic manufacturers. Key competitors include:

• Stimulants: Adderall XR, Vyvanse
• Non-stimulants: Atomoxetine (Strattera), guanfacine (Intuniv), clonidine (Kapvay)

COTEMPLA XR-ODT’s competitive advantage hinges on its formulation. While stimulant drugs command significant market share, there is rising interest in non-stimulants owing to their favorable side-effect profiles and lower abuse potential—making COTEMPLA an attractive alternative or adjunct therapy.

3. Pricing & Reimbursement Dynamics

Pricing strategies for novel formulations typically reflect technological advancements and patient convenience. Given the high cost of specialty ADHD medications, insurance reimbursement policies, prior authorization requirements, and formulary placements critically influence market penetration. Supernus’s focus on securing favorable formulary placements and demonstrating cost-effectiveness are vital for maximizing uptake.

4. Prescriber & Patient Acceptance

Clinician adoption depends on clinical efficacy, safety profile, and ease of use. Supernus’s clinical trials demonstrated that COTEMPLA XR-ODT provides comparable efficacy to existing non-stimulant options, with manageable side effects. Patient and caregiver preference for disintegrating tablets can accelerate prescriptions.

5. Patent and Exclusivity Considerations

Patent protection covers formulation technology and specific dosing claims, providing market exclusivity for several years post-launch. Litigation or patent expiry could permit generics, pressuring pricing and sales volumes [2].

---

Financial Trajectory Forecast

Initial Market Penetration (Year 1-2)

• Launch Dynamics: Supernus’s early adoption campaigns, physician education programs, and targeted marketing are expected to drive initial prescriptions, primarily in pediatric neurology and psychiatry clinics.
• Estimated Sales: Based on comparable neurology niche drugs, initial sales could range from USD 50 million to USD 100 million in North America, with the potential for rapid growth if the product secures strong formulary coverage.

Mid-Term Growth (Year 3-5)

• Market Expansion: Broader adoption across adult ADHD populations and international markets.
• Revenue Milestones: Potential to reach USD 250 million to USD 500 million annually, contingent on formulary wins, price negotiations, and patient acceptance.
• Regulatory Expansions: FDA approval for additional indications (e.g., hypertension, off-label uses) could diversify revenue streams.

Long-Term Outlook (Year 6+)

• Market Saturation & Competition: Patent expiries might introduce generics, compressing margins.
• Pipeline Synergies: New formulations, combination therapies, or proprietary delivery platforms could sustain revenue growth.
• Global Diversification: Entry into emerging markets, particularly where ADHD diagnosis and treatment are still expanding, may add incremental revenues.

---

Risks & Challenges

• Competitive Response: Generics and new entrants could erode market share.
• Pricing Pressures: Payer push for value-based outcomes may limit reimbursement levels.
• Regulatory & Legal Risks: Patent challenges and compliance issues could delay or reduce revenue.
• Market Penetration: Slow uptake due to clinician conservatism or patient resistance.

---

Strategic Implications for Stakeholders

• Investors: Prioritize companies with strong patent positions, proven sales execution, and expanding indications.
• Pharmaceutical Companies: Focus on innovative delivery platforms, clinical differentiation, and strategic partnerships to expand reach.
• Healthcare Providers: Evaluate the comparative efficacy, adherence benefits, and insurance coverage when prescribing new formulations.

---

Key Takeaways

• COTEMPLA XR-ODT is strategically positioned to capitalize on growing demand for patient-centric ADHD therapies, facilitated by technological innovation and changing prescribing patterns.
• Its success hinges on navigating competitive pressures, securing favorable formulary positions, and demonstrating cost-effectiveness.
• The evolving landscape, marked by increasing diagnosis rates and approval of non-stimulant therapies, presents substantial growth opportunities, though these are offset by patent expirations and generic competition.
• As the market matures, diversification into international markets and expansion into additional indications could sustain long-term revenue streams.
• Stakeholders should monitor regulatory developments, patent landscapes, and payer dynamics to optimize ROI.

---

FAQs

1. What distinguishes COTEMPLA XR-ODT from other ADHD medications?
COTEMPLA XR-ODT’s oral disintegrating tablet format offers rapid disintegration, ease of administration, and improved adherence, especially beneficial for children and patients with swallowing difficulties, setting it apart from traditional tablets and capsules.

2. How does the competitive landscape impact COTEMPLA XR-ODT’s financial prospects?
Intense competition from established stimulants and non-stimulants, along with imminent patent expiries, could pressure pricing and market share, influencing revenue growth trajectories.

3. What role do reimbursement policies play in the product’s market success?
High-cost specialty medications rely heavily on favorable insurance coverage and formulary placement. Successful alignment with payers through demonstrating value can accelerate adoption and revenue growth.

4. Are there growth opportunities for COTEMPLA XR-ODT beyond the U.S.?
Yes, emerging markets with expanding ADHD awareness and increasing healthcare infrastructure present significant opportunities for international expansion, contingent on regulatory approvals.

5. What risks could impact the long-term financial trajectory of COTEMPLA XR-ODT?
Patent challenges, generic competition, evolving regulatory standards, and payer reimbursement pressures pose significant risks to sustained profitability.

---

References

[1] Fortune Business Insights, “ADHD Drugs Market Size, Share & Industry Analysis,” 2022.

[2] U.S. Food and Drug Administration, “Patent Protections and Exclusivities,” 2023.