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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 seventy-one patent family members in twenty-eight 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:	71
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
Worldwide Clinical Trials	Phase 4
Prometrika, LLC	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

Anatomical Therapeutic Chemical (ATC) Classes for AZSTARYS

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

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 ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a 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.

Patents protecting AZSTARYS

Methylphenidate-prodrugs, processes of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting AZSTARYS

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-003	May 7, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Commave Therap	AZSTARYS	dexmethylphenidate hydrochloride; serdexmethylphenidate chloride	CAPSULE;ORAL	212994-001	May 7, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a 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: ⤷ Try a Trial

Patent: 20239746
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2019011640
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 46486
Estimated Expiration: ⤷ Try a Trial

China

Patent: 0234636
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 51619
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 7172
Estimated Expiration: ⤷ Try a Trial

Patent: 7652
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 63614
Estimated Expiration: ⤷ Try a Trial

Patent: 20502091
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 19006670
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 4751
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 1903928
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 2337138
Estimated Expiration: ⤷ Try a Trial

Patent: 190091461
Estimated Expiration: ⤷ Try a 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
World Intellectual Property Organization (WIPO)	2018107132		⤷ Try a Trial
South Korea	20190091461	메틸페니데이트-프로드러그를 포함하는 조성물, 이를 제조 및 사용하는 방법	⤷ Try a Trial
Poland	2736510		⤷ Try a Trial
Israel	267172	הרכבים המכילים קדם-תרופות-מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration