Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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Lisdexamfetamine dimesylate - Generic Drug Details

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What are the generic sources for lisdexamfetamine dimesylate and what is the scope of freedom to operate?

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.

Recent Clinical Trials for lisdexamfetamine dimesylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yale UniversityPhase 3
Nova Scotia Health AuthorityPhase 2
Aaron KeshenPhase 2

See all lisdexamfetamine dimesylate clinical trials

Recent Litigation for lisdexamfetamine dimesylate

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 lisdexamfetamine dimesylate litigation

Generic filers with tentative approvals for LISDEXAMFETAMINE DIMESYLATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial70MGCAPSULE;ORAL
  Start Trial  Start Trial60MGCAPSULE;ORAL
  Start Trial  Start Trial50MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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)
Paragraph IV (Patent) Challenges for LISDEXAMFETAMINE DIMESYLATE
Tradename Dosage Ingredient NDA Submissiondate
VYVANSE CAPSULE;ORAL lisdexamfetamine dimesylate 021977 2011-02-23

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 208510-004 Jan 28, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-007 Oct 30, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-006 Jan 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-001 Jan 28, 2017 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 lisdexamfetamine dimesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1644019 122013000079 Germany   Start 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
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
1644019 549 Finland   Start Trial
1644019 CR 2013 00043 Denmark   Start 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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