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.

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.

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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

Drug patent expirations by year for VYVANSE

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

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-003	Feb 23, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-005	Dec 10, 2007	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-005	Jan 28, 2017	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-001	Jan 28, 2017	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-004	Dec 10, 2007	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-001	Feb 23, 2007	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Canada	2428971	NOUVEAU COMPOSE PHARMACEUTIQUE CONTENANT DU SULFATNOUVEAU COMPOSE PHARMACEUTIQUE CONTENANT DU SULFATE D'ABACAVIR ET PROCEDES DE FABRICATION ET D'UTILIE D'ABACAVIR ET PROCEDES DE FABRICATION ET D'UTILISATION ASSOCIES SATION ASSOCIES (A NOVEL PHARMACEUTICAL COMPOUND CONTAINING ABACAVIA NOVEL PHARMACEUTICAL COMPOUND CONTAINING ABACAVIR SULFATE AND METHODS OF MAKING AND USING SAME R SULFATE AND METHODS OF MAKING AND USING SAME)	⤷ Sign Up
Canada	2512951	CONJUGUES D'HYDRATES DE CARBONE UTILES POUR EMPECHER L'INTOXICATION AUX MEDICAMENTS REGLEMENTES (CARBOHYDRATE CONJUGATES TO PREVENT ABUSE OF CONTROLLED SUBSTANCES)	⤷ Sign Up
Spain	2500117		⤷ Sign Up
South Korea	20040095228		⤷ Sign Up
Canada	2527646	COMPOSES D'AMPHETAMINE RESISTANT AUX ABUS (ABUSE RESISTANT AMPHETAMINE COMPOUNDS)	⤷ Sign Up
China	1747737	Carbohydrate conjugates to prevent abuse of controlled substances	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004062614		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VYVANSE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1644019	549	Finland	⤷ Sign Up
1644019	122013000079	Germany	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: LISDEXAMFETAMINE, OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; AUTHORISATION NUMBER AND DATE: PL08081/0050-52 20200901
1644019	CR 2013 00043	Denmark	⤷ Sign Up	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	1390058-4	Sweden	⤷ Sign Up	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	C01644019/01	Switzerland	⤷ Sign Up	VERTRETERLOESCHUNG
1644019	2020C/543	Belgium	⤷ Sign Up	PRODUCT NAME: LISDEXAMFETAMINE, OPTIONEEL IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDE-ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE562026, BE562035, BE562044, BE562053, BE562062, BE562071 20200520
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description