VYVANSE Drug Patent Profile

When do Vyvanse patents expire, and what generic alternatives are available?

Vyvanse is a drug marketed by Takeda Pharms Usa and is included in two NDAs.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Seventeen suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vyvanse

A generic version of VYVANSE was approved as lisdexamfetamine dimesylate by ALKEM LABS LTD on August 25^th, 2023.

Summary for VYVANSE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	65
Patent Applications:	150
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

Recent Clinical Trials for VYVANSE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Minnesota	Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3
Yale University	Phase 2/Phase 3

See all VYVANSE clinical trials

Pharmacology for VYVANSE

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

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

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	021977-007	Oct 30, 2014	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-003	Feb 23, 2007	AB	RX	Yes	Yes
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-005	Dec 10, 2007	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-005	Jan 28, 2017	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-001	Jan 28, 2017	AB	RX	Yes	No
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-004	Dec 10, 2007	AB	RX	Yes	No

International Patents for VYVANSE

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

Country	Patent Number	Title	Estimated Expiration
Japan	4691500
Mexico	PA05012850	COMPUESTOS DE ANFETAMINA RESISTENTES AL ABUSO. (ABUSE RESISTANT AMPHETAMINE COMPOUNDS.)
European Patent Office	2080511	Active agent delivery systems and methods for protecting and administering active agents
China	101869713	Active agent delivery systems and methods for protecting and administering active agents
European Patent Office	1401374	NOUVEAU COMPOSE PHARMACEUTIQUE CONTENANT D'ATENOLOL ET PROCEDES DE FABRICATION ET D'UTILISATION ASSOCIES (A NOVEL PHARMACEUTICAL COMPOUND CONTAINING ATENOLOL AND METHODS OF MAKING AND USING SAME)
China	1476325	活性物质的输送系统和活性物质的保护和施用方法 (Active agent delivery systems and methods for protecting and administering active agents)

Supplementary Protection Certificates for VYVANSE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1644019	C01644019/01	Switzerland		VERTRETERLOESCHUNG
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	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	LUC00189	Luxembourg		PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: PL08081/0050-52 20200901
1644019	549	Finland