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Last Updated: October 23, 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
⤷  Try it Free⤷  Try it Free50MGCAPSULE;ORAL
⤷  Try it Free⤷  Try it Free40MGCAPSULE;ORAL
⤷  Try it Free⤷  Try it Free30MGCAPSULE;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 208510-002 Jan 28, 2017 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-001 Feb 23, 2007 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-006 Jan 28, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-004 Dec 10, 2007 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-001 Jan 28, 2017 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 CR 2013 00043 Denmark ⤷  Try it Free 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 122013000079 Germany ⤷  Try it Free PRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; REGISTRATION NO/DATE: 86155.00.00 86156.00.00 86157.00.00 20130318; FIRST REGISTRATION: UK PL 08081/0050-2 20130201
1644019 LUC00189 Luxembourg ⤷  Try it Free 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 549 Finland ⤷  Try it Free
1644019 37/2016 Austria ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Moodys
Harvard Business School
Medtronic
AstraZeneca

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