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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for azstarys
*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 |
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
Methylphenidate-prodrugs, processes of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
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
| 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 | |||
| >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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 754751 | Compositions comprising methylphenidate-prodrugs, processes of making and using the same | ⤷ Sign Up |
| Israel | 297652 | הרכבים המכילים קדם-תרופות-מתילפנידט, תהליכים להכנה ושימוש בהם (Compositions comprising methylphenidate-prodrugs, processes of making and using the same) | ⤷ Sign Up |
| Hungary | E032113 | ⤷ Sign Up | |
| Mexico | 2019001093 | PROFARMACOS DE METILFENIDATO, PROCESOS DE ELABORACION Y USO DE LOS MISMOS. (METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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