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Last Updated: April 21, 2024

~ Buy the AZSTARYS (dexmethylphenidate hydrochloride; serdexmethylphenidate chloride) Drug Profile, 2024 PDF Report in the Report Store ~

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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  Try a Trial

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
Drug Prices for AZSTARYS

See drug prices for AZSTARYS

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AZSTARYS
Generic Entry Date for AZSTARYS*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Worldwide Clinical TrialsPhase 4
Premier Research Group plcPhase 4
Corium, Inc.Phase 4

See all AZSTARYS clinical trials

Pharmacology for AZSTARYS

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

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

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

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

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
>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.

Country Patent Number Title Estimated Expiration
South Africa 201903928 COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME ⤷  Try a Trial
Lithuania 2736510 ⤷  Try a Trial
Japan 2014521656 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.