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Last Updated: October 1, 2022

MYDAYIS Drug Patent Profile


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Which patents cover Mydayis, and when can generic versions of Mydayis launch?

Mydayis is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-three patent family members in thirty countries.

The generic ingredient in MYDAYIS is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

DrugPatentWatch® Generic Entry Outlook for Mydayis

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for MYDAYIS
Drug Prices for MYDAYIS

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Recent Clinical Trials for MYDAYIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lindner Center of HOPEPhase 2
Mayo ClinicPhase 2
NYU Langone HealthPhase 3

See all MYDAYIS clinical trials

Paragraph IV (Patent) Challenges for MYDAYIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MYDAYIS Extended-release Capsules amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 12.5 mg and 25 mg 022063 1 2017-08-07
MYDAYIS Extended-release Capsules amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 37.5 mg and 50 mg 022063 1 2017-08-03

US Patents and Regulatory Information for MYDAYIS

MYDAYIS is protected by three US patents and two FDA Regulatory Exclusivities.

Patents protecting MYDAYIS

Sustained release delivery of amphetamine salts
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER

Controlled dose drug delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Controlled dose drug delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER

FDA Regulatory Exclusivity protecting MYDAYIS

INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-001 Jun 20, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-001 Jun 20, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-003 Jun 20, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MYDAYIS

International Patents for MYDAYIS

See the table below for patents covering MYDAYIS around the world.

Country Patent Number Title Estimated Expiration
Austria 495731 See Plans and Pricing
African Intellectual Property Organization (OAPI) 13075 Sustained released delivery of amphetamine salts. See Plans and Pricing
Cyprus 1112335 See Plans and Pricing
Japan 2008303223 ORAL PULSED DOSE DRUG DELIVERY SYSTEM See Plans and Pricing
Germany 60335807 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Harvard Business School
Express Scripts
Johnson and Johnson
Moodys

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.