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Last Updated: October 6, 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 021977-005 Dec 10, 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 021977-003 Feb 23, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-004 Dec 10, 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 208510-006 Jan 28, 2017 RX Yes Yes 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
Israel 155905 PHARMACEUTICAL COMPOSITIONS CONTAINING POLYPEPTIDES COVALENTLY ATTACHED TO ACTIVE AGENTS AND METHODS FOR MAKING AND USING SAME See Plans and Pricing
Australia 2004204804 Carbohydrate conjugates to prevent abuse of controlled substances See Plans and Pricing
Australia 2004202699 Use of protein conformation for the protection and release of chemical compounds See Plans and Pricing
Israel 194439 PHARMACEUTICAL COMPOSITIONS CONTAINING POLYPEPTIDES COVALENTLY ATTACHED TO ACTIVE AGENTS AND METHODS FOR MAKING AND USING SAME See Plans and Pricing
Canada 2420590 SYSTEMES DE LIBERATIONS D'AGENTS ACTIFS ET PROCEDES DE PROTECTION ET D'ADMINISTRATION D'AGENTS ACTIFS (ACTIVE AGENT DELIVERY SYSTEMS AND METHODS FOR PROTECTING ANDADMINISTERING ACTIVE AGENTS) See Plans and Pricing
South Korea 100905628 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 549 Finland See Plans and Pricing
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 1390058-4 Sweden See Plans and Pricing 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 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
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 C01644019/01 Switzerland See Plans and Pricing VERTRETERLOESCHUNG
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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