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Last Updated: September 30, 2022

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 sixty-nine 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:69
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
What excipients (inactive ingredients) are in AZSTARYS?AZSTARYS excipients list
DailyMed Link:AZSTARYS at DailyMed
Drug patent expirations by year for AZSTARYS
DrugPatentWatch® Estimated Generic Entry Opportunity 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
KemPharm, Inc.Phase 3

See all AZSTARYS clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methylphenidate-prodrugs, processes of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methylphenidate-prodrugs, processes of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting AZSTARYS

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

Patent: 20239746
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2019011640
Estimated Expiration: See Plans and Pricing

Canada

Patent: 46486
Estimated Expiration: See Plans and Pricing

China

Patent: 0234636
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 51619
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7172
Estimated Expiration: See Plans and Pricing

Japan

Patent: 63614
Estimated Expiration: See Plans and Pricing

Patent: 20502091
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 19006670
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4751
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2337138
Estimated Expiration: See Plans and Pricing

Patent: 190091461
Estimated Expiration: See Plans and Pricing

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 201308766 METHYLPHENIDATE-PRODRUGS,PROCESSES OF MAKING AND USING THE SAME See Plans and Pricing
Ukraine 112654 ПРОЛІКИ МЕТИЛФЕНІДАТУ (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME) See Plans and Pricing
Israel 267172 הרכבים המכילים קדם-תרופות-מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same) See Plans and Pricing
Israel 230650 מתילפנידאט-מטרימי תרופות ותהליכים להכנתם ולשימוש בהם (Methylphenidate-prodrugs and processes of making and using the same) See Plans and Pricing
Japan 2019112462 メチルフェニデート−プロドラッグ、その製造法及び使用法 (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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.