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Lisdexamfetamine dimesylateis the generic ingredient in one branded drug marketed by Shire Development and Shire Dev Llc, and is included in two NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Lisdexamfetamine dimesylate has one hundred and forty-seven patent family members in twenty-six countries.
One supplier is listed for this compound. There are five tentative approvals for this compound.
Summary for LISDEXAMFETAMINE DIMESYLATE
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||18|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for LISDEXAMFETAMINE DIMESYLATE|
|DailyMed Link:||LISDEXAMFETAMINE DIMESYLATE at DailyMed|
Recent Clinical Trials for LISDEXAMFETAMINE DIMESYLATE
Identify potential brand extensions & 505(b)(2) entrants
|Purdue Pharma, Canada||Phase 4|
|University of Birmingham||N/A|
|Yale University||Phase 3|
Generic filers with tentative approvals for LISDEXAMFETAMINE DIMESYLATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for LISDEXAMFETAMINE DIMESYLATE
|Drug Class||Central Nervous System Stimulant |
|Physiological Effect||Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for LISDEXAMFETAMINE DIMESYLATE
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Shire Development||VYVANSE||lisdexamfetamine dimesylate||CAPSULE;ORAL||021977-007||Oct 30, 2014||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Shire Dev Llc||VYVANSE||lisdexamfetamine dimesylate||TABLET, CHEWABLE;ORAL||208510-004||Jan 28, 2017||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|Shire Development||VYVANSE||lisdexamfetamine dimesylate||CAPSULE;ORAL||021977-005||Dec 10, 2007||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1644019||37/2016||Austria||Start Trial||PRODUCT NAME: LISDEXAMFETAMIN, OPTIONAL IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, INSBESONDERE EINES MESILAT-SALZES; NAT. REGISTRATION NO/DATE: 136851-136853 20160412; FIRST REGISTRATION: PL08081/0050-PL08081/0052 20130201|
|1644019||CR 2013 00043||Denmark||Start Trial||PRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET MESYLAT ELLER HYDROCHLORID SALT DERAF; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201|
|1644019||301019||Netherlands||Start Trial||PRODUCT NAME: LISDEXAMFETAMINE, DESGEWENST IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDEZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 124498 20190528; FIRST REGISTRATION: GB PL 08081/0050-52 20130201|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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