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

Constraining patent/regulatory exclusivity:

10,584,112

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
Premier Research Group plc	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.

This potential generic entry date is based on patent 10,584,112.

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	10,858,341
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes	10,759,778		Y
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	212994-001	May 7, 2021		RX	Yes	No	10,584,113		Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No	10,584,113		Y

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
Russian Federation	2573835	ПРОЛЕКАРСТВА МЕТИЛФЕНИДАТА, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (METHYLPHENIDATE PRODRUGS, METHODS OF THEIR OBTAINING AND APPLICATION)
Israel	297652	הרכבים המכילים קדם-תרופות-מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same)
Finland	3551619
South Korea	20140081761
Finland	3551619

Market Dynamics and Financial Trajectory for AZSTARYS

Last updated: March 5, 2026

What Is AZSTARYS and Its Approved Indication?

AZSTARYS (serdexmethylphenidate and dexmethylphenidate) is a combination stimulant medication approved by the U.S. Food and Drug Administration (FDA) in July 2021. It targets attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 and older. The formulation leverages a prodrug component (serdexmethylphenidate) that converts to active methylphenidate over time, providing sustained symptom control.

How Does AZSTARYS Fit Into the ADHD Pharmacotherapy Market?

The ADHD drug market is sizable, with a global valuation projected to reach USD 18 billion by 2023 and an average annual growth rate of 6% (GlobalData, 2022). The U.S. accounts for roughly 60% of sales, driven by high diagnosis rates and a preference for stimulant medications.

AZSTARYS enters an established market dominated by brands like Concerta, Adderall, Vyvanse, and Ritalin. In 2022, these products collectively generated over USD 8 billion in U.S. sales (IQVIA, 2022). New formulations offering improved safety, dosing flexibility, or duration of effect typically capture sales within this space.

Market Adoption and Revenue Potential

Initial prescriptions for AZSTARYS in late 2021 were conservative, owing to limited awareness and insurance coverage constraints. Since then, prescription volume has increased as prescriber familiarity and formulary placements improve:

• Q2 2023 Prescriptions: Approx. 250,000 units dispensed in the U.S.
• Market Share: Estimated at 2% among stimulant ADHD medications, with potential to reach 8-10% over five years if growth trends continue.

Projected sales depend on several factors:

• Pricing: Wholesale acquisition cost (WAC) estimated at USD 350 per month per patient, similar to competing sustained-release methylphenidate formulations.
• Patient Penetration: Assumed to reach 1 million U.S.-treated patients by 2028, capturing a progressively larger share as prescriber awareness improves.
• Reimbursement: Insurance coverage expansion is pivotal; initial coverage remains limited but improves with formulary inclusion.

Assuming a conservative 5% adoption rate of the target population annually, revenues could approximate USD 70-100 million by 2025, with potential growth to USD 300 million by 2028.

Competitive Landscape and Key Differentiators

AZSTARYS competes primarily with Vyvanse, Concerta, and Quillivant XR. Key differentiators include:

• Mechanism of Action: Combines immediate and extended release via prodrug, enabling smoother symptom control.
• Efficacy: Similar or slightly superior to existing formulations based on clinical trials showing sustained symptom reduction over 12 hours.
• Safety Profile: Favorable in early post-marketing surveillance, with no unique adverse signals.

Market share growth hinges on clinical adoption and comparator product lifecycle dynamics. Generic competitors, such as generic methylphenidate XR, exert downward price pressure but often lack the convenience or dosing flexibility of branded AZSTARYS.

Financial Trajectory: R&D, Launch, and Growth Phase

• R&D Investment: Estimated at USD 100-150 million, including clinical trials, regulatory, and commercial development.
• Launch Year (2021): Initial sales contributed approximately USD 15-30 million in 2022.
• Growth Trajectory: Expected to accelerate as prescriber confidence and insurance coverage increase, with sales projections reaching USD 50-100 million in 2024 and exceeding USD 200 million in 2026.

Payer negotiations will significantly influence net pricing and revenue realization. The expansion into adult ADHD could further escalate growth potential.

Regulatory Outlook and Market Expansion

Beyond the U.S., AZSTARYS has the potential for regulatory approval in Europe, Japan, and other markets. Approval timelines depend on regional regulatory processes, with a typical range of 12-36 months post-application submission. Efficacy and safety data from ongoing and planned post-marketing studies will influence broader acceptance.

Key Risks and Market Challenges

• Market Penetration: Slow prescriber adoption could limit revenue potential.
• Pricing Pressures: Competition from generics and price-sensitive healthcare systems.
• Regulatory Hurdles: Delays in expanding indications or approvals in new geographies.
• Market Saturation: Existing stimulant formulations have entrenched prescriber and patient loyalty.

Summary Table

Aspect	Details
Market Size (2023)	USD 18 billion (global ADHD market)
U.S. Market Share (2023)	2-3% of stimulant ADHD prescriptions
Estimated U.S. Sales (2025)	USD 70-100 million
Pricing (monthly/patient)	USD 350
Prescriptions (2023 Q2)	Approx. 250,000 units in the U.S.
Growth Rate	6% annual global market growth

Key Takeaways

• AZSTARYS competes in a mature ADHD market, with early indications of moderate adoption.
• Revenue growth depends heavily on prescriber acceptance and insurance coverage.
• The drug's differentiation lies in its combination formulation offering sustained symptom control.
• Long-term value hinges on expanding indications, geographic approvals, and market penetration strategies.
• Generic competition and pricing pressures pose ongoing challenges.

FAQs

1. What is the primary advantage of AZSTARYS over other ADHD medications?
It provides a combination of immediate and extended-release effects, aiming for smoother symptom control over 12 hours.

2. How soon could AZSTARYS achieve significant market share?
If prescriber familiarity and insurance coverage improve steadily, it could approach double-digit market share within five years.

3. What are the main barriers to AZSTARYS’s growth?
Limited initial insurance coverage, prescriber hesitancy, and competition from entrenched generic formulations.

4. Could AZSTARYS gain FDA approval for adult ADHD?
Potentially, if clinical trial data support efficacy and safety, possibly within 2-3 years.

5. How does the drug's pricing compare with rivals?
Pricing is similar to immediate-release methylphenidate formulations, with a monthly WAC around USD 350.

---

References

1. GlobalData. (2022). ADHD market forecast and analysis.
2. IQVIA. (2022). U.S. prescription drug data.
3. U.S. Food and Drug Administration. (2021). AZSTARYS approval announcement.