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Generated: April 19, 2019

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Lisdexamfetamine dimesylate - Generic Drug Details

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What are the generic drug sources for lisdexamfetamine dimesylate and what is the scope of lisdexamfetamine dimesylate patent protection?

Lisdexamfetamine dimesylate is the generic ingredient in one branded drug marketed by Shire Development and Shire Dev Llc, and is included in two NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lisdexamfetamine dimesylate has one hundred and forty-seven patent family members in twenty-six countries.

One supplier is listed for this compound. There are five tentative approvals for this compound.

Pharmacology for lisdexamfetamine dimesylate
Medical Subject Heading (MeSH) Categories for lisdexamfetamine dimesylate
Synonyms for lisdexamfetamine dimesylate
(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
BCP24044
CETWSOHVEGTIBR-FORAGAHYSA-N
CHEMBL1201178
CTK5B2291
D04747
DTXSID60209653
Elvanse (TN)
L-Lysine-d-amphetamine dimesylate
LDX
Ldx;Lisdexamfetamine mesilate;Lisdexamfetamine mesylate;Nrp 104;Nrp-104;Spd 489
lis-dexamfetamine 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
SB17446
SCHEMBL678421
SJT761GEGS
SPD 489
SPD-489
SPD489
UNII-SJT761GEGS
Venvanse
Vyvanse
Vyvanse (TN)
Tentative approvals for LISDEXAMFETAMINE DIMESYLATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial70MGCAPSULE;ORAL
➤ Try a Free Trial➤ Try a Free Trial60MGCAPSULE;ORAL
➤ Try a Free Trial➤ Try a Free Trial50MGCAPSULE;ORAL

US Patents and Regulatory Information for lisdexamfetamine dimesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-003 Jan 28, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-002 Jan 28, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-007 Oct 30, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for lisdexamfetamine dimesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1644019 549 Finland ➤ Try a Free Trial
1644019 CA 2013 00043 Denmark ➤ Try a Free 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 CR 2013 00043 Denmark ➤ Try a Free Trial 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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