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Medtronic
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Harvard Business School
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Julphar
Accenture
Cantor Fitzgerald

Generated: February 17, 2019

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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 five patents protecting this drug and two Paragraph IV challenges.

This drug has forty-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-three suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-003 Jun 20, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 022063-003 Jun 20, 2017 ➤ Sign Up ➤ Sign Up
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-001 Jun 20, 2017 ➤ Sign Up ➤ Sign Up
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017 ➤ Sign Up ➤ Sign Up
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MYDAYIS
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Capsules 37.5 mg and50 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsules 12.5 mg and 25 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Farmers Insurance
McKinsey
Healthtrust
Deloitte
UBS
Fuji
Julphar
Citi

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