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Moodys
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Medtronic
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Dow
Farmers Insurance
Colorcon
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Generated: May 23, 2018

DrugPatentWatch Database Preview

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.

Three suppliers are 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
BIS(METHANESULFONIC ACID); VYVANSE
CETWSOHVEGTIBR-FORAGAHYSA-N
CHEMBL1201178
CTK5B2291
D04747
DTXSID60209653
Elvanse (TN)
L-Lysine-d-amphetamine dimesylate
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
OR074086
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 Trial20MGCAPSULE;ORAL
➤ Try a Free Trial➤ Try a Free Trial70MGCAPSULE;ORAL
➤ Try a Free Trial➤ Try a Free Trial60MGCAPSULE;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 Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-001 Feb 23, 2007 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-003 Feb 23, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-003 Feb 23, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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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Non-Orange Book US Patents for lisdexamfetamine dimesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,375,082 Abuse-resistant hydrocodone compounds ➤ Try a Free Trial
7,060,708 Active agent delivery systems and methods for protecting and administering active agents ➤ Try a Free Trial
6,716,452 Active agent delivery systems and methods for protecting and administering active agents ➤ Try a Free Trial
7,338,939 Abuse-resistant hydrocodone compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for lisdexamfetamine dimesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013000079 Germany ➤ Try a Free Trial 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 ➤ Try a Free Trial 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
/2016 Austria ➤ Try a Free Trial 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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Express Scripts
Chubb
Johnson and Johnson
Farmers Insurance
Deloitte
Healthtrust
Accenture

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