By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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MYDAYIS Drug 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-five 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 |
|---|---|
| Mayo Clinic | Phase 2 |
| Lindner Center of HOPE | Phase 2 |
| New York University School of Medicine | Phase 4 |
Pharmacology for MYDAYIS
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Paragraph IV (Patent) Challenges for MYDAYIS
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MYDAYIS | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 022063 | 2017-08-07 |
| MYDAYIS | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 022063 | 2017-08-03 |
US Patents and Regulatory Information for MYDAYIS
Expired US Patents for MYDAYIS
International Patents for MYDAYIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1112335 | Try Before You Buy |
| Mexico | PA05003129 | Try Before You Buy |
| Spain | 2360046 | Try Before You Buy |
| Ecuador | SP055702 | Try Before You Buy |
| Denmark | 1542660 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
