➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
McKesson
Dow
Mallinckrodt
Harvard Business School

Last Updated: June 18, 2021

DrugPatentWatch Database Preview

VYVANSE Drug Profile


Email this page to a colleague

« Back to Dashboard

Which patents cover Vyvanse, and when can generic versions of Vyvanse launch?

Vyvanse is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are eighteen patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and forty-eight patent family members in twenty-seven 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.

DrugPatentWatch® Generic Entry Outlook for Vyvanse

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

< Available with Subscription >

  Try Before You Buy

Drug patent expirations by year for VYVANSE
Drug Prices for VYVANSE

See drug prices for VYVANSE

Drug Sales Revenue Trends for VYVANSE

See drug sales revenues for VYVANSE

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VYVANSE
Generic Entry Dates for VYVANSE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for VYVANSE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, CHEWABLE;ORAL

*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

SponsorPhase
Yale UniversityPhase 2/Phase 3
Purdue Pharma, CanadaPhase 4
Matthew O'BrienPhase 4

See all VYVANSE clinical trials

Pharmacology for VYVANSE
Paragraph IV (Patent) Challenges for VYVANSE
Tradename Dosage Ingredient NDA Submissiondate
VYVANSE CAPSULE;ORAL lisdexamfetamine dimesylate 021977 2020-04-09
VYVANSE CAPSULE;ORAL lisdexamfetamine dimesylate 021977 2011-02-23

US Patents and Regulatory Information for VYVANSE

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 021977-002 Feb 23, 2007 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-001 Feb 23, 2007 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-004 Dec 10, 2007 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-003 Jan 28, 2017 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-002 Jan 28, 2017 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VYVANSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1644019 CR 2013 00043 Denmark   Try Before You Buy 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 122013000079 Germany   Try Before You Buy PRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; REGISTRATION NO/DATE: 86155.00.00 86156.00.00 86157.00.00 20130318; FIRST REGISTRATION: UK PL 08081/0050-2 20130201
1644019 CA 2013 00043 Denmark   Try Before You Buy 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 C01644019/01 Switzerland   Try Before You Buy PRODUCT NAME: LISDEXAMPHETAMIN; REGISTRATION NO/DATE: SWISSMEDIC 63023 27.03.2014
1644019 37/2016 Austria   Try Before You Buy 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 LUC00189 Luxembourg   Try Before You Buy PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: 202009252 A 202009257 20200901 (LU); PL08081/0050-52 20130201 (GB)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
AstraZeneca
Colorcon
Boehringer Ingelheim
Moodys

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.