DrugPatentWatch Database Preview
MYDAYIS Drug Profile
Which 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.
Summary for MYDAYIS
| International Patents: | 33 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 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
| Sponsor | Phase |
|---|---|
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Shire Dev Llc | MYDAYIS | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063-001 | Jun 20, 2017 | Start Trial | Start Trial |
| Shire Dev Llc | MYDAYIS | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063-004 | Jun 20, 2017 | Start Trial | Start Trial |
| Shire Dev Llc | MYDAYIS | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063-002 | Jun 20, 2017 | Start Trial | Start Trial |
| Shire Dev Llc | MYDAYIS | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063-003 | Jun 20, 2017 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MYDAYIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 167470 | Start Trial |
| European Patent Office | 1542660 | Start Trial |
| Japan | 2006503071 | Start Trial |
| Morocco | 27469 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
