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
Corium, Inc.	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
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No			Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No			Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes			Y	Y
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	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
Philippines	12014500049	METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME
Serbia	65591	KOMPOZICIJE KOJE SADRŽE PROLEKOVE METILFENIDATA, POSTUPCI ZA PRIPREMU I UPOTREBE ISTIH (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
South Korea	101869885
Serbia	55812	METILFENIDATNI PROLEKOVI, PROCESI ZA NJIHOVO DOBIJANJE I NJIHOVA PRIMENA (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Israel	267172	הרכבים המכילים קדם-תרופות-מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same)
South Korea	20160047599
Denmark	2736510

Market Dynamics and Financial Trajectory of AZSTARYS (Serdexmethylphenidate and Dexmethylphenidate)

Last updated: December 27, 2025

Executive Summary

AZSTARYS (serdexmethylphenidate and dexmethylphenidate) emerged as an innovative therapy for Attention Deficit Hyperactivity Disorder (ADHD), combining delayed-release and immediate-release formulations to enhance efficacy and compliance. Since its FDA approval in July 2021, AZSTARYS has positioned itself within a competitive ADHD pharmaceutical landscape characterized by rapid growth, patent protections, and evolving patient needs. This report delineates the market drivers, competitive positioning, revenue projections, and strategic opportunities influencing AZSTARYS's financial trajectory.

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What Are the Core Market Drivers for AZSTARYS?

1. Growing Prevalence of ADHD

• According to the CDC, the prevalence of diagnosed ADHD in children in the United States stands at approximately 9.4% (6.1 million children as of 2016-2019) [1].
• Adult ADHD diagnoses are rising, expanding market potential. The adult ADHD market is projected to grow at a CAGR of approximately 6% till 2028 [2].

2. Unmet Medical Needs & Drug Innovation

• AZSTARYS offers a novel pharmacokinetic profile with extended therapeutic coverage, intended to reduce dosing frequency and adverse effects.
• Its delivery system differentiates it from conventional stimulants, meeting patient and caregiver demands for improved compliance.

3. Competitive Landscape & Market Share

Competitors	Products	Market Share (2022)	Differentiators
Shire / Takeda	Adderall XR, Vyvanse	~50%	Established efficacy, broad use
Supernus / Alkermes	Quillivant XR, Concerta	~20%	Extended-release formulations
Others (generic stimulants)	Methylphenidate, Dexedrine, Ritalin	Remaining	Cost-effective, generic availability

AZSTARYS's niche hinges on its delivery mechanism, aiming for better adherence over existing therapies.

4. Regulatory and Reimbursement Environment

• The FDA’s approval under Priority Review reflected confidence in its novel approach [3].
• Reimbursement coverage by major insurers influences prescribing patterns, vital for revenue growth.

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What Are the Key Financial Projections and Trajectory?

1. Revenue Estimates and Market Penetration

Year	Estimated Global Market Size (USD)	AZSTARYS Market Share	Estimated Revenue (USD)	Notes
2022	$5 billion (global ADHD medicinals)	0.5%	$25 million	Initial adoption phase
2023	$5.5 billion	1%	$55 million	Slight increase due to expanding prescriber base
2024	$6 billion	2%	$120 million	Enhanced awareness, expanded formulary access
2025	$6.5 billion	3%	$195 million	Increased market penetration, competitor dynamics

Note: Assumes steady growth and market share increase based on launch strategies, physician adoption, and competitive responses.

2. Cost Structure & Profitability Outlook

Cost Component	Approximate Contribution (%)	Notes
R&D and Regulatory Expenses	15-20%	Considering ongoing post-approval studies
Marketing & Physician Education	25-30%	Key to driving adoption
Manufacturing & Distribution	20-25%	Economies of scale expected over time
General & Administrative	10-15%	Corporate overhead

Expected gross margins estimated at 60-70%, with profitability achievable within 2-3 years if market penetration targets are met.

3. Patent Protections and Market Exclusivity

• Patent protection extends until 2030, covering formulation, delivery system, and method of use [4].
• Opportunities to extend pipeline with new formulations or indications bolster long-term revenue.

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How Does AZSTARYS Compare to Existing ADHD Medications?

Feature	AZSTARYS	Vyvanse	Adderall XR	Concerta
Delivery	Once daily, delayed-release + immediate-release	Once daily	Multiple doses per day	Once daily
Duration	Up to 12 hours	Up to 14 hours	4-6 hours (immediate)	Up to 12 hours
Abuse Potential	Lower (due to formulation)	Moderate	High	Moderate
Side Effect Profile	Similar to stimulants	Similar, potentially fewer peaks	Similar	Similar

Implications: AZSTARYS's innovative formulation could result in a competitive advantage via its extended duration, reduced abuse potential, and improved tolerability.

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What Are the Strategic Market Opportunities?

1. Expanding Indications

• Pediatric and adult ADHD.
• Off-label uses in narcolepsy and certain mood disorders.
• Potential exploration in other neurocognitive conditions.

2. Geographic Expansion

Region	Strategy	Timeline
European Union	Regulatory approval and market access	2024-2026
Asia-Pacific	Local partnerships, licensing	2025-2028
Latin America	Market entry via registrations	2024-2025

3. Partnerships & Collaborations

• Partnering with healthcare providers for clinical adoption.
• Licensing agreements for non-U.S. markets.

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What Are Expected Risks and Challenges?

Risk Factors	Impact & Mitigation Strategies
Regulatory delays or hurdles	Close collaboration with regulators, proactive documentation
Competitive responses (e.g., generics)	Patent strategies, clinical differentiation, pricing policies
Prescriber inertia	Robust education campaigns, real-world evidence studies
Market saturation	Diversifying indications, geographic expansion

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Conclusion: The Financial Trajectory Outlook

AZSTARYS is positioned for steady growth driven by its innovative delivery system in a burgeoning ADHD market. Early adoption is promising, with projected revenues reaching approximately $195 million globally by 2025, assuming aggressive market penetration and favorable reimbursement policies. Long-term success hinges on strategic expansion, patent protections, and continued differentiating features.

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Key Takeaways

• Growing Market: ADHD prevalence continues to rise, expanding the addressable patient population.
• Innovative Formulation: AZSTARYS’s unique pharmacokinetics offer competitive advantages over existing therapies.
• Revenue Potential: Early estimates project revenues to reach nearly $200 million globally by 2025.
• Strategic Opportunities: International expansion and pipeline development are critical for sustained growth.
• Risks and Challenges: Patent expirations, generic competition, and market adoption hurdles require vigilant management.

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FAQs

Q1: When did AZSTARYS receive FDA approval, and what are its key features?
A1: AZSTARYS was approved by the FDA in July 2021. It features a novel delivery system combining serdexmethylphenidate (a prodrug) with immediate-release dexmethylphenidate, providing extended symptom control with reduced abuse potential.

Q2: How does AZSTARYS's market share compare to established ADHD medications?
A2: As a newly launched product, AZSTARYS’s initial market share was minimal (~0.5%), but it is expected to expand as prescribers adopt the medication, potentially capturing 3-5% of the ADHD medication market within five years.

Q3: What are the main competitive advantages of AZSTARYS?
A3: Its extended-release profile, lower abuse potential, and once-daily dosing position it as a convenient and safer alternative to traditional stimulants, appealing to both patients and prescribers.

Q4: What factors could influence AZSTARYS’s future revenue growth?
A4: Regulatory approvals in international markets, formulary inclusion, prescriber acceptance, competitive responses, and patent protections are pivotal factors influencing growth.

Q5: What are the potential challenges in AZSTARYS’s market expansion?
A5: Challenges include regulatory delays, reimbursement hurdles, generic competition, and prescriber inertia, which could slow adoption and limit revenue growth.

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References

1. Centers for Disease Control and Prevention (CDC). (2022). ADHD prevalence data.
2. MarketWatch. (2022). Global ADHD therapeutics market forecast.
3. FDA. (2021). AZSTARYS approval announcement.
4. Patent Scope. (2022). AZSTARYS patents and exclusivity information.