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MYDAYIS Drug Profile
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See Plans and PricingWhich patents cover Mydayis, and when can generic versions of Mydayis launch?
Mydayis is a drug marketed by Shire Dev Llc 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.
US ANDA Litigation and Generic Entry Outlook for Mydayis
There have been thirteen 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 |
| 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 |
| 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 |
Recent Litigation for MYDAYIS
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Shire Development LLC v. SpecGx LLC | 2018-05-25 |
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
| Shire Development LLC v. Impax Laboratories LLC | 2018-04-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| KVK-Tech, Inc. | 2017-12-11 |
| Amerigen Pharmaceuticals Limited | 2017-01-13 |
| Mylan Pharmaceuticals Inc. | 2016-10-04 |
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 |
|---|---|---|
| Norway | 336938 | Start Trial |
| Brazil | 0314486 | Start Trial |
| Norway | 20051986 | Start Trial |
| Croatia | P20050356 | Start Trial |
| Ecuador | SP055702 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
