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Last Updated: August 10, 2020

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LISDEXAMFETAMINE DIMESYLATE - Generic Drug Details

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What are the generic drug sources for lisdexamfetamine dimesylate and what is the scope of freedom to operate?

Lisdexamfetamine dimesylate is 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.

Recent Clinical Trials for LISDEXAMFETAMINE DIMESYLATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Purdue Pharma, CanadaPhase 4
University of BirminghamN/A
Yale UniversityPhase 3

See all LISDEXAMFETAMINE DIMESYLATE clinical trials

Generic filers with tentative approvals for LISDEXAMFETAMINE DIMESYLATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial20MGCAPSULE;ORAL
  Start Trial  Start Trial70MGCAPSULE;ORAL
  Start Trial  Start Trial60MGCAPSULE;ORAL

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
Medical Subject Heading (MeSH) Categories for LISDEXAMFETAMINE DIMESYLATE
Paragraph IV (Patent) Challenges for LISDEXAMFETAMINE DIMESYLATE
Tradename Dosage Ingredient NDA Submissiondate
VYVANSE CAPSULE;ORAL lisdexamfetamine dimesylate 021977 2011-02-23

US Patents and Regulatory Information 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

Supplementary Protection Certificates for LISDEXAMFETAMINE DIMESYLATE

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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