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Last Updated: October 24, 2019

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VYVANSE Drug Profile

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When do Vyvanse patents expire, 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.

This drug has one hundred and forty-seven patent family members in twenty-six 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.

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

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
Matthew O'BrienPhase 4
Aaron KeshenPhase 2
Nova Scotia Health AuthorityPhase 2

See all VYVANSE clinical trials

Recent Litigation for VYVANSE

Identify potential future generic entrants

District Court Litigation
Case NameDate
IMPAX LABORATORIES, INC. v. ACTAVIS LABORATORIES FL, INC.2015-09-17
SHIRE LLC v. MYLAN PHARMACEUTICALS, INC.2012-02-02
Shire LLC v. Watson Laboratories Inc2012-01-05

See all VYVANSE litigation

Pharmacology for VYVANSE
Synonyms for VYVANSE
(2S)-2,6-Diamino-N-((1S)-1-methyl-2-phenylethyl)hexanamide
(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
(2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanamide
(2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanimidic acid
137L333
608137-32-2
608137-33-3
AKOS030254940
AN-27750
BCP24044
CETWSOHVEGTIBR-FORAGAHYSA-N
CHEBI:135925
CHEMBL1201178
CHEMBL1201222
CTK5B2291
D04747
D08130
DB01255
DTXSID00209652
DTXSID60209653
Elvanse (TN)
GTPL7213
H645GUL8KJ
HSDB 8277
L-lysine-d-amphetamine
L-Lysine-d-amphetamine dimesylate
LDX
Ldx;Lisdexamfetamine mesilate;Lisdexamfetamine mesylate;Nrp 104;Nrp-104;Spd 489
lis-dexamfetamine dimesylate
Lisdexamfetamine
Lisdexamfetamine (INN)
Lisdexamfetamine [INN]
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
LS-187377
Lys-Amp
Lys-d-Amp
NRP 104
NRP-104
NRP104
SB17446
SCHEMBL158949
SCHEMBL678421
SJT761GEGS
SPD 489
SPD-489
SPD489
UNII-H645GUL8KJ
UNII-SJT761GEGS
Venvanse
Vyvanse (TN)
ZINC11680943
Paragraph IV (Patent) Challenges for VYVANSE
Tradename Dosage Ingredient NDA Submissiondate
VYVANSE CAPSULE;ORAL lisdexamfetamine dimesylate 021977 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
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-005 Dec 10, 2007 RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-006 Jan 28, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No   Start Trial   Start Trial Y   Start Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-001 Feb 23, 2007 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VYVANSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1644019 549 Finland   Start Trial
1644019 SPC/GB13/052 United Kingdom   Start Trial PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201
1644019 CA 2013 00043 Denmark   Start Trial 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
1644019 2013/038 Ireland   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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