You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Lisdexamfetamine dimesylate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, MSN, and Teva Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for lisdexamfetamine dimesylate

See drug prices for lisdexamfetamine dimesylate

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
⤷  Try a Trial⤷  Try a Trial70MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial60MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a 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 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
Norwich LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 214547-007 Aug 25, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-005 Dec 10, 2007 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Inc LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 214134-005 Aug 25, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 217068-001 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

Make Better Decisions: Try a trial or see plans & pricing

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.