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Last Updated: August 11, 2022

VYVANSE Drug Patent Profile


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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 nineteen 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 August 24, 2023. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $3.4bn, indicating a strong incentive for generic entry.

There have been eight 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 six tentative approvals for the generic drug (lisdexamfetamine dimesylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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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
University of MinnesotaEarly Phase 1
Yale UniversityPhase 2/Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2/Phase 3

See all VYVANSE clinical trials

Pharmacology for VYVANSE
Paragraph IV (Patent) Challenges for VYVANSE
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 VYVANSE

VYVANSE is protected by nineteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYVANSE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VYVANSE

Abuse-resistant amphetamine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse resistant lysine amphetamine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse resistant lysine amphetamine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)

Abuse-resistant amphetamine prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: 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
Takeda Pharms Usa VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-002 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 021977-006 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 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 021977-004 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 208510-003 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 TABLET, CHEWABLE;ORAL 208510-002 Jan 28, 2017 RX Yes No 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 VYVANSE

See the table below for patents covering VYVANSE around the world.

Country Patent Number Title Estimated Expiration
Austria 545427 See Plans and Pricing
China 1720059 Sustained release pharmaceutical compounds to prevent abuse of controlled substances See Plans and Pricing
Israel 174683 See Plans and Pricing
Mexico PA05012850 COMPUESTOS DE ANFETAMINA RESISTENTES AL ABUSO. (ABUSE RESISTANT AMPHETAMINE COMPOUNDS.) See Plans and Pricing
European Patent Office 1644019 COMPOSES D'AMPHETAMINE RESISTANT AUX ABUS (ABUSE RESISTANT AMPHETAMINE COMPOUNDS) 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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VYVANSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CR 2013 00043 Denmark See Plans and Pricing 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 301019 Netherlands See Plans and Pricing 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 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 122013000079 Germany See Plans and Pricing 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 LUC00189 Luxembourg See Plans and Pricing PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: PL08081/0050-52 20200901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.