Mydayis Patent Expiration

Mydayis is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 5 US drug patents filed in 2017. Out of these, 2 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 24, 2029. Details of Mydayis's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE42096 Oral pulsed dose drug delivery system
Oct, 2018

(5 years ago)

Expired
USRE41148 Oral pulsed dose drug delivery system
Oct, 2018

(5 years ago)

Expired
US6913768 Sustained release delivery of amphetamine salts
May, 2023

(1 year, 1 month ago)

Expired
US9173857 Controlled dose drug delivery system
May, 2026

(1 year, 9 months from now)

Active
US8846100 Controlled dose drug delivery system
Aug, 2029

(5 years from now)

Active


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Mydayis and ongoing litigations to help you estimate the early arrival of Mydayis generic.

Mydayis's Litigations

Mydayis has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 13, 2017, against patent number US8846100. The petitioner Amerigen Pharmaceuticals Limited, challenged the validity or infringement of this patent, with Shire, LLC as the respondent. Click below to track the latest information on how companies are challenging Mydayis's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8846100 December, 2017 FWD Entered Shire LLC KVK-Tech, Inc.
US9173857 December, 2017 FWD Entered Shire, LLC KVK-Tech, Inc.
US8846100 January, 2017 Terminated-Settled Shire, LLC Amerigen Pharmaceuticals Limited


FDA has granted some exclusivities to Mydayis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mydayis, 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 Mydayis.

Exclusivity Information

Mydayis holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Mydayis's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jun 20, 2020
M(M-248) Sep 13, 2022
Pediatric Exclusivity(PED) Mar 13, 2023

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Mydayis 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 Mydayis's family patents as well as insights into ongoing legal events on those patents.

Mydayis's family patents

Mydayis has patent protection in a total of 30 countries. It's US patent count contributes only to 23.7% of its total global patent coverage. 11 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 Mydayis.

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Generic Launch

Generic Release Date:

Mydayis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 24, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Mydayis Generics:

Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate is the generic name for the brand Mydayis. 29 different companies have already filed for the generic of Mydayis, with Actavis Elizabeth having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mydayis's generic

How can I launch a generic of Mydayis before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Mydayis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mydayis's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Mydayis -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
37.5 mg and 50 mg 03 Aug, 2017 1 31 Jan, 2022 24 Aug, 2029 Deferred
12.5 mg and 25 mg 07 Aug, 2017 1 31 Jan, 2022 24 Aug, 2029 Deferred




About Mydayis

Mydayis is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for managing symptoms of Attention Deficit Hyperactivity Disorder. Mydayis uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as an active ingredient. Mydayis was launched by Takeda Pharms Usa in 2017.

Market Authorisation Date:

Mydayis was approved by FDA for market use on 20 June, 2017.

Active Ingredient:

Mydayis uses Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate as the active ingredient. Check out other Drugs and Companies using Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate ingredient

Treatment:

Mydayis is used for managing symptoms of Attention Deficit Hyperactivity Disorder.

Dosage:

Mydayis is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
9.375MG;9.375MG;9.375MG;9.375MG CAPSULE, EXTENDED RELEASE Prescription ORAL
3.125MG;3.125MG;3.125MG;3.125MG CAPSULE, EXTENDED RELEASE Prescription ORAL
6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE Prescription ORAL
12.5MG;12.5MG;12.5MG;12.5MG CAPSULE, EXTENDED RELEASE Prescription ORAL