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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.
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
|Suppliers / Packagers:||1|
|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
|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
|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|
|Amerigen Pharmaceuticals Limited||2017-01-13|
|Mylan Pharmaceuticals Inc.||2016-10-04|
Paragraph IV (Patent) Challenges for MYDAYIS
|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|