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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 Therap and is included in one NDA. There are six patents protecting this drug.

This drug has eighty-one patent family members in twenty-nine 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 will be eligible for patent challenges on May 7, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

International Patents:	81
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

Drug patent expirations by year for AZSTARYS

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

Generic Entry Date for AZSTARYS^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

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

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

Patents protecting AZSTARYS

Methylphenidate-prodrugs, processes of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE

Methylphenidate-oxoacid conjugates, processes of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting AZSTARYS

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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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 Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-002	May 7, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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
Patent: Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Estimated Expiration: ⤷ Sign Up

Patent: 20239746
Patent: COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2019011640
Patent: composições que compreendem pró-fármacos de metilfenidato, processos de fabricação e uso das mesmas
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 46486
Patent: COMPOSITIONS COMPRENANT DES PROMEDICAMENTS METHYLPHENIDATES, PROCEDES DE FABRICATION ET D'UTILISATION DE CES COMPOSITIONS (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Estimated Expiration: ⤷ Sign Up

China

Patent: 0234636
Patent: 包含哌醋甲酯前药的组合物，其制造和使用方法 (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0240748
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 51619
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 51619
Patent: COMPOSITIONS COMPRENANT DES PROMÉDICAMENTS MÉTHYLPHÉNIDATES, PROCÉDÉS DE FABRICATION ET D'UTILISATION DE CES COMPOSITIONS (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Estimated Expiration: ⤷ Sign Up

Patent: 64802
Patent: COMPOSITIONS COMPRENANT DES PROMÉDICAMENTS MÉTHYLPHÉNIDATES, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME)
Estimated Expiration: ⤷ Sign Up

Finland

Patent: 51619
Estimated Expiration: ⤷ Sign Up

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: ⤷ Sign Up

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: ⤷ Sign Up

Japan

Patent: 63614
Estimated Expiration: ⤷ Sign Up

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: ⤷ Sign Up

Lithuania

Patent: 51619
Estimated Expiration: ⤷ Sign Up

Mexico

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: ⤷ Sign Up

New Zealand

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

Poland

Patent: 51619
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 51619
Estimated Expiration: ⤷ Sign Up

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: ⤷ Sign Up

Slovenia

Patent: 51619
Estimated Expiration: ⤷ Sign Up

South Africa

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

South Korea

Patent: 2337138
Estimated Expiration: ⤷ Sign Up

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

Spain

Patent: 79262
Estimated Expiration: ⤷ Sign Up

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
Israel	269322	מתילפנידאט-מטרימי תרופות תהליכים להכנתם ולשימוש בהם (Methylphenidate-prodrugs, processes of making and using the same)	⤷ Sign Up
South Korea	101869885		⤷ Sign Up
Denmark	3551619		⤷ Sign Up
Slovenia	2736510		⤷ Sign Up
Colombia	6900135	Profármacos de metilfenidato, procesos de elaboración y utilización de los mismos	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

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Questions you can ask:

Summary for AZSTARYS

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

Recent Clinical Trials for AZSTARYS

Pharmacology for AZSTARYS

Patents protecting AZSTARYS

FDA Regulatory Exclusivity protecting AZSTARYS

When does loss-of-exclusivity occur for AZSTARYS?

Make Better Decisions: Try a trial or see plans & pricing

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