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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 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-four 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
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MYDAYIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYDAYIS
Prior Art and Litigation Support	Order Prior Art and Litigation support for MYDAYIS
DailyMed Link:	MYDAYIS at DailyMed

US Patents and Regulatory Information for MYDAYIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-001	Jun 20, 2017		RX	Yes	No
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-002	Jun 20, 2017		RX	Yes	No			Y
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-001	Jun 20, 2017		RX	Yes	No

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
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017

Paragraph IV (Patent) Challenges for MYDAYIS

Drugname	Dosage	Strength	RLD	Date
	Extended-release Capsules	37.5 mg and50 mg
	Extended-release Capsules	12.5 mg and 25 mg

International Patents for MYDAYIS

Country	Patent Number	Estimated Expiration
Cyprus	1112335
Slovenia	1542660
Australia	2003272619