Azstarys Patent Expiration

Azstarys is a drug owned by Commave Therapeutics Sa. It is protected by 6 US drug patents filed in 2021 out of which none have expired yet. Azstarys's patents will be open to challenges from 07 May, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 09, 2037. Details of Azstarys's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US10584112 Methylphenidate-prodrugs, processes of making and using the same
Dec, 2037

(12 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10954213 Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Dec, 2037

(12 years from now)

Active
US10858341 Compositions comprising methylphenidate-prodrugs, processes of making and using the same
Dec, 2037

(12 years from now)

Active
US10584113 Methylphenidate-prodrugs, processes of making and using the same
Dec, 2037

(12 years from now)

Active
US10759778 Methylphenidate-prodrugs, processes of making and using the same
Dec, 2037

(12 years from now)

Active
US9079928 Methylphenidate-oxoacid conjugates, processes of making and using the same
Jul, 2032

(7 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Azstarys's patents.

Given below is the list of recent legal activities going on the following patents of Azstarys.

Activity Date Patent Number
Patent litigations
transaction for FDA Determination of Regulatory Review Period 30 Jan, 2024 US9079928
Payment of Maintenance Fee, 4th Year, Large Entity 31 Dec, 2023 US10858341
Payment of Maintenance Fee, 4th Year, Large Entity 31 Dec, 2023 US10759778
transaction for FDA Determination of Regulatory Review Period 29 Nov, 2023 US9079928
Payment of Maintenance Fee, 4th Year, Large Entity 05 Sep, 2023 US10584112
Payment of Maintenance Fee, 4th Year, Large Entity 05 Sep, 2023 US10584113
Email Notification 17 May, 2023 US9079928
Electronic Review 17 May, 2023 US9079928
Second letter to regulating agency to determine regulatory review period 16 May, 2023 US9079928
Payment of Maintenance Fee, 8th Year, Large Entity 05 Jan, 2023 US9079928


FDA has granted several exclusivities to Azstarys. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Azstarys, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Azstarys.

Exclusivity Information

Azstarys holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Azstarys's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 07, 2026

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US patents provide insights into the exclusivity only within the United States, but Azstarys is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Azstarys's family patents as well as insights into ongoing legal events on those patents.

Azstarys's Family Patents

Azstarys has patent protection in a total of 28 countries. It's US patent count contributes only to 28.4% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Azstarys.

Family Patents

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Generic Launch

Generic Release Date:

Azstarys's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 09, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Azstarys Generics:

There are no approved generic versions for Azstarys as of now.





About Azstarys

Azstarys is a drug owned by Commave Therapeutics Sa. It is used for managing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) with Serdexmethylphenidate and Dexmethylphenidate. Azstarys uses Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride as an active ingredient. Azstarys was launched by Commave Therap in 2021.

Approval Date:

Azstarys was approved by FDA for market use on 07 May, 2021.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Azstarys is 07 May, 2021, its NCE-1 date is estimated to be 07 May, 2025.

Active Ingredient:

Azstarys uses Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride as the active ingredient. Check out other Drugs and Companies using Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride ingredient

Treatment:

Azstarys is used for managing symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) with Serdexmethylphenidate and Dexmethylphenidate.

Dosage:

Azstarys is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 10.4MG BASE;EQ 52.3MG BASE CAPSULE Prescription ORAL
EQ 5.2MG BASE;EQ 26.1MG BASE CAPSULE Prescription ORAL
EQ 7.8MG BASE;EQ 39.2MG BASE CAPSULE Prescription ORAL