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
Summary for MYDAYIS
| International Patents: | 33 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MYDAYIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MYDAYIS |
| What excipients (inactive ingredients) are in MYDAYIS? | MYDAYIS excipients list |
| DailyMed Link: | MYDAYIS at DailyMed |
Recent Clinical Trials for MYDAYIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lindner Center of HOPE | Phase 2 |
| Mayo Clinic | Phase 2 |
| NYU Langone Health | Phase 3 |
Pharmacology for MYDAYIS
| Drug Class | Central Nervous System Stimulant Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
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
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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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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
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