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Last Updated: October 26, 2021

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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 patent protection?

Lisdexamfetamine dimesylate is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in two NDAs. There are nineteen 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-eight patent family members in twenty-seven 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
⤷  Free Forever Trial⤷  Free Forever Trial70MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial60MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial50MGCAPSULE;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 2020-04-09
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
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-003 Jan 28, 2017 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-006 Jan 28, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-004 Dec 10, 2007 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-002 Feb 23, 2007 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-003 Feb 23, 2007 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-004 Dec 10, 2007 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for lisdexamfetamine dimesylate

Country Patent Number Estimated Expiration
New Zealand 544162 ⤷  Free Forever Trial
Australia 3723900 ⤷  Free Forever Trial
Egypt 26032 ⤷  Free Forever Trial
Israel 163666 ⤷  Free Forever Trial
Brazil PI0414876 ⤷  Free Forever Trial
Eurasian Patent Organization 010295 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2006121552 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for lisdexamfetamine dimesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1644019 2020C/543 Belgium ⤷  Free Forever Trial PRODUCT NAME: LISDEXAMFETAMINE, OPTIONEEL IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDE-ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE562026, BE562035, BE562044, BE562053, BE562062, BE562071 20200520
1644019 1390058-4 Sweden ⤷  Free Forever Trial PRODUCT NAME: LISDEXAMFETAMIN VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT, SAERSKILT ETT MESYLATSALT; NAT. REG. NO/DATE: 47382 20130722; FIRST REG.: GB PL 08081/0050-52 20130201
1644019 37/2016 Austria ⤷  Free Forever 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 301019 Netherlands ⤷  Free Forever 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
1644019 C01644019/01 Switzerland ⤷  Free Forever Trial FORMER OWNER: SHIRE LLC, US
1644019 LUC00189 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: 202009252 A 202009257 20200901 (LU); PL08081/0050-52 20130201 (GB)
1644019 SPC/GB13/052 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Dow
Johnson and Johnson
Mallinckrodt
Baxter

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