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VYVANSE Drug Profile

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

Vyvanse is a drug marketed by Shire Development and Shire Dev Llc and is included in two NDAs. There are eighteen patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

Summary for VYVANSE

US Patents:	18
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	15
Clinical Trials:	54
Patent Applications:	79
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VYVANSE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYVANSE
DailyMed Link:	VYVANSE at DailyMed

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.

Pharmacology for VYVANSE

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

Medical Subject Heading (MeSH) Categories for VYVANSE

Central Nervous System Stimulants

Dopamine Uptake Inhibitors

Synonyms for VYVANSE

(2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenyl-ethyl]hexanamide; methanesulfonic acid

(2S)-2,6-DIAMINO-N-[(1S)-1-METHYL-2-PHENYLETHYL]HEXANAMIDE DIMETHANESULFONATE

137L333

608137-33-3

AKOS030254940

AN-27750

BIS(METHANESULFONIC ACID); VYVANSE

CETWSOHVEGTIBR-FORAGAHYSA-N

CHEMBL1201178

CTK5B2291

D04747

DTXSID60209653

Elvanse (TN)

L-Lysine-d-amphetamine dimesylate

lis-dexamfetamine dimesylate

Lisdexamfetamine dimesylate

Lisdexamfetamine dimesylate (USAN)

Lisdexamfetamine dimesylate [USAN]

Lisdexamfetamine dimesylate solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material

Lisdexamfetamine mesilate

Lisdexamfetamine mesilate (JAN)

Lisdexamfetamine mesylate

LS-186600

Lys-Amp

Lys-d-Amp

NRP 104

NRP-104

OR074086

SCHEMBL678421

SJT761GEGS

SPD 489

SPD-489

SPD489

UNII-SJT761GEGS

Venvanse

Vyvanse (TN)

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
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-005	Dec 10, 2007		RX	Yes	No			Y
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-005	Jan 28, 2017		RX	Yes	No
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-006	Dec 10, 2007		RX	Yes	No
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-006	Jan 28, 2017		RX	Yes	Yes			Y	Y
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-001	Feb 23, 2007		RX	Yes	No

Paragraph IV (Patent) Challenges for VYVANSE

Drugname	Dosage	Strength	RLD	Date
	Capsules	20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg

International Patents for VYVANSE

Country	Document Number	Estimated Expiration
Japan	2005524648
Eurasian Patent Organization	200501895
European Patent Office	1644019
Israel	194439
Cyprus	1113130

Supplementary Protection Certificates for VYVANSE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
13/038	Ireland		PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY A MESYLATE SALT; NAT REGISTRATION NO/DATE: PA0689/006/001 PA0689/006/002
2013 00043	Denmark		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
/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
2013000079	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
90058-4	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