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Generated: May 23, 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 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.

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-001 Jun 20, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 022063-001 Jun 20, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-003 Jun 20, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-003 Jun 20, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial
➤ Subscribe Extended-release Capsules 12.5 mg and 25 mg ➤ Subscribe ➤ Try a Free Trial

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Federal Trade Commission
Teva
Farmers Insurance
Johnson and Johnson
McKinsey

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