AZSTARYS Drug Patent Profile

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

Azstarys is a drug marketed by Commave Therap and is included in one NDA. There are six patents protecting this drug.

This drug has eighty-seven patent family members in thirty-one countries.

The generic ingredient in AZSTARYS is dexmethylphenidate hydrochloride; serdexmethylphenidate chloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride; serdexmethylphenidate chloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Azstarys

Azstarys was eligible for patent challenges on May 7, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 9, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AZSTARYS

International Patents:	87
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	4
Drug Prices:	Drug price information for AZSTARYS
What excipients (inactive ingredients) are in AZSTARYS?	AZSTARYS excipients list
DailyMed Link:	AZSTARYS at DailyMed

See drug prices for AZSTARYS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AZSTARYS

NDA:

212994

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for AZSTARYS

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

Sponsor	Phase
NYU Langone Health	Phase 4
Worldwide Clinical Trials	Phase 4
Prometrika, LLC	Phase 4

See all AZSTARYS clinical trials

Pharmacology for AZSTARYS

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

US Patents and Regulatory Information for AZSTARYS

AZSTARYS is protected by six US patents and one FDA Regulatory Exclusivity.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes			Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No

International Patents for AZSTARYS

When does loss-of-exclusivity occur for AZSTARYS?

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

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

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 AZSTARYS around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	2736510
South Korea	20160047599
Portugal	2736510

Market Dynamics and Financial Trajectory for AZSTARYS

Last updated: July 27, 2025

Introduction

AZSTARYS (serdexmethylphenidate and dexmethylphenidate) is an innovative pharmaceutical product developed by Corium, Inc., approved by the FDA in June 2021 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six years and older. Its unique formulation offers a once-daily, extended-release profile, positioning it as a competitive alternative within the ADHD medication market. Understanding the intricate market dynamics and financial trajectory of AZSTARYS involves examining its therapeutic profile, regulatory landscape, competitive environment, and commercial strategy.

Market Overview: ADHD and Pharmaceutical Industry Landscape

Global ADHD Market

The global ADHD therapeutics market has seen sustained growth, driven primarily by increased awareness, improved diagnostic rates, and expanding treatment options. The market size was valued at approximately USD 12 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of about 6% through 2030 [1].

Key Drivers

• Rising prevalence: An estimated 6-8% of children worldwide are diagnosed with ADHD, with similar trends observed in adults.
• Treatment paradigm shift: There is a growing preference for long-acting, non-stimulant, and novel formulations due to safety profiles and convenience.
• Regulatory support: The FDA’s approval of new formulations like AZSTARYS bolsters innovation-driven market expansion.

Challenges

• Safety and side effects: Concerns over stimulant medications’ addictive potential and cardiovascular risks continue to influence prescribing patterns.
• Generic competition: Expiry of patents on major branded drugs leads to price competition and market erosion.

AZSTARYS: Therapeutic and Regulatory Milestones

Innovative Profile

AZSTARYS combines serdexmethylphenidate (SDX), a prodrug designed to provide a gradual and sustained release, with dexmethylphenidate, enhancing its efficacy and duration. Its pharmacokinetic profile offers potential advantages in reducing abuse potential and improving adherence [2].

Regulatory Status

• FDA Approval: June 2021, setting the stage for commercial launch.
• Labeling: Indications include ADHD management in children, aligning with existing market demographic.

Clinical Efficacy

Phase 3 trials demonstrated significant improvements in ADHD symptomatology with favorable tolerability, bolstering confidence among prescribers and stakeholders [3].

Market Penetration and Commercial Strategies

Target Segments

• Pediatric patients (ages 6–17): Primary focus, leveraging the safety and efficacy profile demonstrated in trials.
• Clinicians seeking non-stimulant or extended-release alternatives: Positioning AZSTARYS as a novel, effective option.

Sales Channels

• Specialty pharmacies and pediatric clinics are critical to initial distribution.
• Partnerships with managed-care organizations aim to optimize coverage and reimbursement.

Pricing Strategy

Initial pricing aligns with premium ADHD medications, with mechanisms to ensure competitiveness against generic stimulants. Prescription co-pay assistance programs are anticipated to expand patient access.

Competitive Landscape

Key Players

• Pharmaceutical giants: Shire (now part of Takeda), Eli Lilly, and Novartis dominate with established products like Vyvanse, Adderall XR, and Ritalin.
• Emerging formulations: Companies developing non-stimulant and long-acting variants, including Daytrana and Qelbree, pose competitive threats.

Differentiators

• Improved safety profile: Reduced abuse potential.
• Extended duration: Once-daily dosing with sustained symptom control.
• Prodrug technology: Innovative delivery mechanism potentially offering safer pharmacokinetics.

Market Challenges

• Brand loyalty: Prescriber and patient preferences for familiar generics.
• Cost considerations: Insurance reimbursement and out-of-pocket costs influence prescription decisions.

Financial Trajectory and Monetization Outlook

Revenue Projections

Initial sales volume remains modest, given the recent FDA approval and phased market entry. Industry analysts estimate that AZSTARYS could generate USD 200–300 million annually within 3–5 years post-launch, assuming successful expansion and market uptake [4].

Factors Influencing Financial Growth

• Market penetration rate: Critical to achieving projected revenues.
• Pricing and reimbursement: Negotiated coverage levels will impact profitability.
• Patent life: The duration of patent exclusivity influences long-term revenue prospects, with potential for patent extensions through formulation or process innovations.

Risks and Opportunities

• Market acceptance: Clinician adoption hinges on perceived benefits over existing therapies.
• Competitive innovations: Entry of new formulations or generics could compress margins.
• Regulatory developments: Additional approvals or safety warnings may alter the commercial viability.

Regulatory and Legal Considerations

• Patent portfolio: Strategically robust to defend against generic challenges.
• Orphan drug or pediatric exclusivity: Potential to extend market monopoly.
• Post-marketing surveillance: Critical for maintaining favorable safety profile and brand reputation.

Conclusion

AZSTARYS’s market dynamics are shaped by its innovative pharmacological profile, strategic regulatory positioning, and the broader ADHD treatment landscape. While initial commercial opportunities are promising, sustained growth depends on effective physician adoption, competitive differentiation, and favorable reimbursement policies. The financial trajectory projects a gradual scaling, contingent upon market acceptance, patent protections, and ongoing product enhancements.

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Key Takeaways

• Innovative Profile: AZSTARYS offers a novel extended-release formulation that aligns with market demand for safer, longer-lasting ADHD treatments.
• Market Potential: The global ADHD therapeutics market’s steady growth, coupled with unmet needs in safety and convenience, positions AZSTARYS for meaningful commercial success.
• Competitive Positioning: Differentiation in safety and duration supports an attractive niche, but overcoming entrenched brand loyalty remains challenging.
• Financial Outlook: Revenue forecasts project a moderate growth trajectory (USD 200–300 million/year within 5 years), assuming effective market penetration and reimbursement.
• Strategic Focus: Ongoing clinical development, patent rights management, and stakeholder engagement are pivotal to maximizing AZSTARYS’s financial and market potential.

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FAQs

1. What makes AZSTARYS different from other ADHD medications?
AZSTARYS combines a prodrug with the active stimulant, providing a sustained and consistent release profile that may reduce abuse potential and improve adherence compared to traditional stimulants.

2. When did AZSTARYS receive FDA approval?
The FDA approved AZSTARYS in June 2021, marking it as a recent entrant in the ADHD treatment landscape.

3. What are the main market challenges AZSTARYS faces?
Key challenges include competition from established generics, clinician and patient acceptance, cost and reimbursement issues, and potential regulatory hurdles.

4. What is the revenue outlook for AZSTARYS?
Industry estimates suggest revenues could reach USD 200–300 million annually within five years, contingent upon successful market adoption and payer coverage.

5. How does AZSTARYS impact the broader ADHD market?
As a potentially safer and more convenient formulation, AZSTARYS could influence prescribing patterns and stimulate innovation in ADHD pharmacotherapies, while also escalating competition with existing therapies.

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Sources
[1] Grand View Research. "Attention Deficit Hyperactivity Disorder (ADHD) Market Size, Share & Trends Analysis." 2022.
[2] FDA. "FDA Approves First Novel Treatment for ADHD in Nearly a Decade." June 2021.
[3] ClinicalTrials.gov. "Serdexmethylphenidate/Dexmethylphenidate in ADHD." Retrieved 2022.
[4] EvaluatePharma. "Market Projections for ADHD Therapies." 2022.