AZSTARYS Drug Patent Profile

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

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

The generic ingredient in AZSTARYS is dexmethylphenidate hydrochloride; serdexmethylphenidate chloride. 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

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Summary for AZSTARYS

US Patents:	6
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for AZSTARYS

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AZSTARYS is ⤷ Start Trial.

This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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

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

Patent: 17371327
Estimated Expiration: ⤷ Start Trial

Patent: 20239746
Estimated Expiration: ⤷ Start Trial

Brazil

Patent: 2019011640
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 46486
Estimated Expiration: ⤷ Start Trial

China

Patent: 0234636
Estimated Expiration: ⤷ Start Trial

Croatia

Patent: 0240748
Estimated Expiration: ⤷ Start Trial

Denmark

Patent: 51619
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 51619
Estimated Expiration: ⤷ Start Trial

Patent: 64802
Estimated Expiration: ⤷ Start Trial

Finland

Patent: 51619
Estimated Expiration: ⤷ Start Trial

Hungary

Patent: 67004
Estimated Expiration: ⤷ Start Trial

Israel

Patent: 7172
Patent: הרכבים המכילים קדם-תרופות-מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same)
Estimated Expiration: ⤷ Start Trial

Patent: 7652
Patent: הרכבים המכילים קדם–תרופות–מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same)
Estimated Expiration: ⤷ Start Trial

Patent: 2584
Patent: הרכבים המכילים קדם-תרופות-מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same)
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 63614
Estimated Expiration: ⤷ Start Trial

Patent: 20502091
Patent: メチルフェニデート−プロドラッグを含む組成物、その製造法及び使用法
Estimated Expiration: ⤷ Start Trial

Lithuania

Patent: 51619
Estimated Expiration: ⤷ Start Trial

Mexico

Patent: 0156
Patent: COMPOSICIONES QUE COMPRENDEN PROFARMACOS DE METILFENIDATO, PROCEDIMIENTOS PARA LA ELABORACION Y USO DE LOS MISMOS (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Estimated Expiration: ⤷ Start Trial

Patent: 19006670
Patent: COMPOSICIONES QUE COMPRENDEN PROFARMACOS DE METILFENIDATO, PROCEDIMIENTOS PARA LA ELABORACION Y USO DE LOS MISMOS. (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME.)
Estimated Expiration: ⤷ Start Trial

New Zealand

Patent: 4751
Patent: Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Estimated Expiration: ⤷ Start Trial

Poland

Patent: 51619
Estimated Expiration: ⤷ Start Trial

Portugal

Patent: 51619
Estimated Expiration: ⤷ Start Trial

San Marino

Patent: 02400217
Estimated Expiration: ⤷ Start Trial

Serbia

Patent: 591
Patent: KOMPOZICIJE KOJE SADRŽE PROLEKOVE METILFENIDATA, POSTUPCI ZA PRIPREMU I UPOTREBE ISTIH (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Estimated Expiration: ⤷ Start Trial

Slovenia

Patent: 51619
Estimated Expiration: ⤷ Start Trial

South Africa

Patent: 1903928
Patent: COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 2337138
Estimated Expiration: ⤷ Start Trial

Patent: 190091461
Patent: 메틸페니데이트-프로드러그를 포함하는 조성물, 이를 제조 및 사용하는 방법
Estimated Expiration: ⤷ Start Trial

Spain

Patent: 79262
Estimated Expiration: ⤷ Start Trial

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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2017371327		⤷ Start Trial
Australia	2020239746		⤷ Start Trial
Brazil	112019011640		⤷ Start Trial
Canada	3046486		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

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Summary for AZSTARYS

When does loss-of-exclusivity occur for AZSTARYS?

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