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Vyvanse is a drug marketed by Shire Development and Shire Dev Llc and is included in two NDAs. There are eighteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and forty-seven patent family members in twenty-six countries.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Vyvanse was eligible for patent challenges on February 23, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 24, 2023. This may change due to patent challenges or generic licensing.
Annual sales in 2018 were $3.3bn, indicating a strong incentive for generic entry.
There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are five tentative approvals for the generic drug (lisdexamfetamine dimesylate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for VYVANSE
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||22|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for VYVANSE|
|Drug Sales Revenues:||Drug sales revenues for VYVANSE|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for VYVANSE|
|DailyMed Link:||VYVANSE at DailyMed|
Generic Entry Opportunity Date for VYVANSE
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for VYVANSE
Identify potential brand extensions & 505(b)(2) entrants
|Purdue Pharma, Canada||Phase 4|
|Matthew O'Brien||Phase 4|
|Nova Scotia Health Authority||Phase 2|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Shire Development||VYVANSE||lisdexamfetamine dimesylate||CAPSULE;ORAL||021977-002||Feb 23, 2007||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Shire Development||VYVANSE||lisdexamfetamine dimesylate||CAPSULE;ORAL||021977-006||Dec 10, 2007||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Shire Development||VYVANSE||lisdexamfetamine dimesylate||CAPSULE;ORAL||021977-001||Feb 23, 2007||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1644019||301019||Netherlands||Start Trial||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||1390058-4||Sweden||Start Trial||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|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|