VYVANSE Drug Patent Profile

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

Summary for VYVANSE

International Patents:	148
US Patents:	19
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	65
Patent Applications:	822
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
What excipients (inactive ingredients) are in VYVANSE?	VYVANSE excipients list
DailyMed Link:	VYVANSE at DailyMed

See drug prices for VYVANSE

See drug sales revenues for VYVANSE

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VYVANSE

NDA:

021977

Dosage:

CAPSULE;ORAL

NDA:

208510

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

Sponsor	Phase
University of Minnesota	Early Phase 1
Yale University	Phase 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

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Anatomical Therapeutic Chemical (ATC) Classes for VYVANSE

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

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.

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

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					Y
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-006	Dec 10, 2007		RX	Yes	No					Y
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-001	Feb 23, 2007		RX	Yes	No					Y
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-004	Dec 10, 2007		RX	Yes	No					Y
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-003	Jan 28, 2017		RX	Yes	No					Y
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-002	Jan 28, 2017		RX	Yes	No					Y

International Patents for VYVANSE

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

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

Supplementary Protection Certificates for VYVANSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1644019	37/2016	Austria		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		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		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		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		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		PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: PL08081/0050-52 20200901