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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Healthtrust
Boehringer Ingelheim
US Department of Justice
McKinsey
AstraZeneca
Queensland Health
Harvard Business School

Generated: June 19, 2018

DrugPatentWatch Database Preview

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. Two suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Drug patent expirations by year for VYVANSE
Pharmacology for VYVANSE
Medical Subject Heading (MeSH) Categories for VYVANSE
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-005 Jan 28, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-006 Jan 28, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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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Paragraph IV (Patent) Challenges for VYVANSE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg ➤ Subscribe 2011-02-23

Non-Orange Book US Patents for VYVANSE

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
7,163,918 Iodothyronine compositions ➤ Sign Up
7,338,939 Abuse-resistant hydrocodone compounds ➤ Sign Up
7,375,082 Abuse-resistant hydrocodone compounds ➤ Sign Up
6,716,452 Active agent delivery systems and methods for protecting and administering active agents ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for VYVANSE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/038 Ireland ➤ Sign Up 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 ➤ Sign Up 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
2013000079 Germany ➤ Sign Up 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
/2016 Austria ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Chubb
Federal Trade Commission
Julphar
Express Scripts
Baxter
Dow
McKinsey
Farmers Insurance

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