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-three patent family members in thirty 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:	83
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
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.

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

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
South Korea	20160047599	메틸페니데이트 프로드러그, 이의 제조 방법 및 사용 방법 (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
European Patent Office	2736510	PROMÉDICAMENTS MÉTHYLPHÉNIDATES, PROCÉDÉS DE FABRICATION ET D'UTILISATION DE CEUX-CI (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Poland	2736510
Israel	297652	הרכבים המכילים קדם-תרופות-מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same)
Japan	6963614
Canada	3123900	METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME

Market Dynamics and Financial Trajectory for AZSTARYS

Introduction to AZSTARYS

AZSTARYS, developed by KemPharm and commercialized by Corium, Inc., is a novel, once-daily treatment for attention deficit hyperactivity disorder (ADHD) in patients aged six years and older. It combines 70% extended-release serdexmethylphenidate (SDX), a prodrug of d-methylphenidate (d-MPH), with 30% immediate-release d-MPH, offering both rapid and sustained therapeutic effects[2][4].

Market Context: ADHD Treatment

The ADHD market is substantial and growing. In 2019, it accounted for approximately $17.9 billion in revenue, with a year-over-year prescription growth rate greater than 4%. The branded portion of the ADHD market was around $7.4 billion, with extended-release products dominating over 97% of the branded prescriptions. The methylphenidate segment, where AZSTARYS operates, saw about 20 million prescriptions and $4.9 billion in sales in 2019[1][4].

Unique Selling Proposition of AZSTARYS

AZSTARYS stands out due to its innovative formulation. The combination of SDX and immediate-release d-MPH provides a dual-action effect, offering rapid onset and extended duration of therapeutic benefits. This unique profile is particularly significant for managing ADHD symptoms effectively throughout the day[2].

FDA Approval and Commercial Launch

AZSTARYS received FDA approval in March 2021, marking a significant milestone for KemPharm and Corium. The commercial launch followed in July 2021, with Corium Inc. leading the efforts. The launch was supported by a double-blind, randomized, placebo-controlled phase 3 study that demonstrated symptom improvement without serious adverse effects[2][4].

Commercial Performance and Challenges

The initial commercial launch of AZSTARYS faced challenges, including COVID-19 related disruptions and the need for greater formulary coverage with major pharmacy benefit managers (PBMs). However, by the third quarter of 2022, Corium had achieved coverage with the three largest PBMs and doubled its field force to 175 representatives. This led to a meaningful increase in prescription volumes starting in July 2022[3].

Financial Trajectory

KemPharm's financial position has been positively impacted by the commercialization of AZSTARYS. Here are some key financial highlights:

• Royalties and Revenue: KemPharm earns royalties from the sales of AZSTARYS. While the amounts are modest, the growing prescription trend is expected to increase these royalties. In 2022, KemPharm reported net revenue of $10.5 million, with a solid balance sheet and cash, cash equivalents, and investments totaling $102.9 million as of December 31, 2022[3].
• Milestones and Growth: The company anticipates reaching one or more sales milestones under the license agreement in 2023, driven by the improving prescription trend. This growth trajectory is crucial for KemPharm's long-term financial health and market presence[3].
• Formulary Coverage and Market Access: Achieving formulary coverage with major PBMs has been a key factor in the drug's commercial success. This coverage has helped in increasing the accessibility of AZSTARYS to a broader patient population[3].

Patient Savings and Support

To enhance patient access, Corium offers a copay savings program for patients with insurance covering AZSTARYS, reducing the cost to as little as $15 per prescription. For patients without coverage, the cost can be as low as $60 per prescription. Additionally, a Starter Kit is available through healthcare providers[5].

Safety and Abuse Considerations

AZSTARYS, being a federally controlled substance (CII), carries a high risk of abuse and misuse, similar to other methylphenidate and amphetamine-containing medications. It is crucial for healthcare providers and patients to be aware of these risks and use the medication as prescribed to avoid overdose and other serious adverse effects[5].

Expert Insights and Clinical Significance

According to Greg Mattingly, M.D., of St. Charles Psychiatric Associates, "The availability of the first medicine to use the novel prodrug SDX expands the therapeutic options that families and their physicians can consider when deciding the most suitable ADHD symptom management treatment for children." This innovative therapy is particularly significant due to its rapid onset and sustained therapeutic effects[2].

Future Outlook and Strategic Positioning

KemPharm and Corium are optimistic about the future of AZSTARYS. The drug's unique formulation and growing market acceptance position it well within the ADHD treatment landscape. As the prescription trend continues to improve, it is expected to contribute significantly to KemPharm's revenue and market share.

Key Takeaways

• Innovative Formulation: AZSTARYS combines extended-release and immediate-release components, offering rapid and sustained therapeutic effects.
• Market Context: The ADHD market is large and growing, with the methylphenidate segment being a significant part.
• Commercial Performance: Despite initial challenges, AZSTARYS has seen increasing prescription volumes following improved formulary coverage.
• Financial Impact: The drug contributes to KemPharm's revenue through royalties and is expected to reach sales milestones in 2023.
• Patient Access: Corium offers copay savings programs to enhance patient access.
• Safety Considerations: AZSTARYS carries a risk of abuse and misuse, necessitating careful use.

FAQs

Q: What is AZSTARYS, and how does it work? A: AZSTARYS is an FDA-approved, once-daily treatment for ADHD, combining 70% extended-release serdexmethylphenidate (SDX) with 30% immediate-release d-MPH, providing both rapid and sustained therapeutic effects.

Q: Who is eligible to use AZSTARYS? A: AZSTARYS is approved for patients aged six years and older with ADHD.

Q: What were the initial challenges faced by AZSTARYS during its commercial launch? A: The launch faced challenges such as COVID-19 disruptions and the need for greater formulary coverage with major PBMs.

Q: How has the financial performance of KemPharm been impacted by AZSTARYS? A: KemPharm has seen an increase in revenue through royalties from AZSTARYS sales, with a solid financial position and growing prescription trend.

Q: What patient savings and support programs are available for AZSTARYS? A: Corium offers a copay savings program reducing the cost to as little as $15 per prescription for insured patients and $60 for those without coverage.

Sources

1. KemPharm Announces Amendment to Licensing Agreement with Gurnet Point - KemPharm Investors.
2. Corium Launches AZSTARYS: Stimulant ADHD Medication - Additudemag.
3. KemPharm Announces FDA Approval of AZSTARYS - KemPharm Investors.
4. KemPharm Announces FDA Approval of AZSTARYS - KemPharm Investors.
5. Patient Savings & Support - AZSTARYS - AZSTARYS Official Website.

Last updated: 2024-12-16