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Last Updated: September 26, 2022

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 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-eight patent family members in twenty-seven countries.

One supplier is listed for this compound. There are six tentative approvals for this compound.

Recent Clinical Trials for lisdexamfetamine dimesylate

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

SponsorPhase
University of MinnesotaEarly Phase 1
Purdue Pharma, CanadaPhase 4
University of BirminghamN/A

See all lisdexamfetamine dimesylate clinical trials

Generic filers with tentative approvals for LISDEXAMFETAMINE DIMESYLATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing70MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing60MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing50MGCAPSULE;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 Strength NDA ANDAs Submitted Submissiondate
VYVANSE Capsules lisdexamfetamine dimesylate 10 mg 021977 1 2020-04-09
VYVANSE Capsules lisdexamfetamine dimesylate 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg 021977 6 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 CAPSULE;ORAL 021977-007 Oct 30, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-002 Jan 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-002 Feb 23, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-004 Jan 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-001 Feb 23, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-002 Feb 23, 2007 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 Title Estimated Expiration
Australia 2001286599 See Plans and Pricing
South Korea 20040095228 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2005000334 See Plans and Pricing
Canada 2428971 NOUVEAU COMPOSE PHARMACEUTIQUE CONTENANT DU SULFATNOUVEAU COMPOSE PHARMACEUTIQUE CONTENANT DU SULFATE D'ABACAVIR ET PROCEDES DE FABRICATION ET D'UTILIE D'ABACAVIR ET PROCEDES DE FABRICATION ET D'UTILISATION ASSOCIES SATION ASSOCIES (A NOVEL PHARMACEUTICAL COMPOUND CONTAINING ABACAVIA NOVEL PHARMACEUTICAL COMPOUND CONTAINING ABACAVIR SULFATE AND METHODS OF MAKING AND USING SAME R SULFATE AND METHODS OF MAKING AND USING SAME) See Plans and Pricing
European Patent Office 1311242 SYSTEMES DE LIBERATIONS D'AGENTS ACTIFS ET PROCEDES DE PROTECTION ET D'ADMINISTRATION D'AGENTS ACTIFS (ACTIVE AGENT DELIVERY SYSTEMS AND METHODS FOR PROTECTING AND ADMINISTERING ACTIVE AGENTS) See Plans and Pricing
Eurasian Patent Organization 200501895 СОЕДИНЕНИЯ АМФЕТАМИНА С ПОНИЖЕННОЙ СПОСОБНОСТЬЮ ВЫЗЫВАТЬ ЗЛОУПОТРЕБЛЕНИЕ ИМИ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lisdexamfetamine dimesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1644019 C01644019/01 Switzerland See Plans and Pricing VERTRETERLOESCHUNG
1644019 2020C/543 Belgium See Plans and Pricing 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 301019 Netherlands See Plans and Pricing 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 37/2016 Austria See Plans and Pricing 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 CA 2013 00043 Denmark See Plans and Pricing PRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER ET MESYLAT SALT; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201
1644019 SPC/GB13/052 United Kingdom See Plans and Pricing 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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