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Last Updated: March 1, 2024

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 two branded drugs marketed by Actavis Elizabeth, Alkem Labs Ltd, Amneal, Apotex, Ascent Pharms Inc, Hikma, Lannett Co Inc, Mylan, Norwich, Prinston Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Takeda Pharms Usa, and Teva Pharms, and is included in eighteen 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.

Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for lisdexamfetamine dimesylate

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Recent Clinical Trials for lisdexamfetamine dimesylate

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

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Generic filers with tentative approvals for LISDEXAMFETAMINE DIMESYLATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial30MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial20MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial70MGCAPSULE;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
Apotex LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 216944-006 Aug 25, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 217442-004 Aug 25, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-003 Jan 28, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Prinston Inc LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 216266-001 Aug 25, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 Title Estimated Expiration
Australia 2008229978 Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances ⤷  Try a Trial
Australia 3723900 Use of protein conformation for the protection and release of chemical compounds ⤷  Try a Trial
Norway 20056211 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 03079972 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lisdexamfetamine dimesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1644019 2013/038 Ireland ⤷  Try a Trial PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY A MESYLATE SALT; NAT REGISTRATION NO/DATE: PA0689/006/001 PA0689/006/002
1644019 CR 2013 00043 Denmark ⤷  Try a 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 CA 2013 00043 Denmark ⤷  Try a Trial 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 549 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.