MYDAYIS Drug Patent Profile
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When do Mydayis patents expire, and what generic alternatives are available?
Mydayis is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.
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 sixteen 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
US Patents: | 2 |
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 |
![MYDAYIS drug patent expirations Drug patent expirations by year for MYDAYIS](/p/graph/s/t/MYDAYIS-patent-expirations.png)
![Drug Prices for MYDAYIS](/p/graph/drug-price/MYDAYIS.png)
Recent Clinical Trials for MYDAYIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mayo Clinic | Phase 2 |
Lindner Center of HOPE | Phase 2 |
NYU Langone Health | Phase 3 |
Pharmacology for MYDAYIS
Drug Class | 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 two US patents.
Patents protecting MYDAYIS
Controlled dose drug delivery system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Controlled dose drug delivery system
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER
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 |
---|---|---|---|
Eurasian Patent Organization | 018082 | ПРЕПАРАТИВНАЯ ФОРМА ДЛЯ ЛЕЧЕНИЯ ГИПЕРАКТИВНОСТИ ПРИ ДЕФИЦИТЕ ВНИМАНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ЕЕ ОСНОВЕ И СПОСОБ ЛЕЧЕНИЯ ГИПЕРАКТИВНОСТИ ПРИ ДЕФИЦИТЕ ВНИМАНИЯ (PREPARATIVE FORMULATION FOR TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER, PHARMACEUTICAL COMPOSITION BASED THEREON AND METHOD FOR TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER) | ⤷ Try a Trial |
Norway | 336938 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 0023055 | ⤷ Try a Trial | |
South Korea | 20050084589 | SUSTAINED RELEASE DELIVERY OF AMPHETAMINE SALTS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |