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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Fish and Richardson
Dow
Julphar
Deloitte
Accenture
Johnson and Johnson
Cantor Fitzgerald
Medtronic

Generated: August 17, 2017

DrugPatentWatch Database Preview

Shire Development Company Profile

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What is the competitive landscape for SHIRE DEVELOPMENT, and what generic alternatives to SHIRE DEVELOPMENT drugs are available?

SHIRE DEVELOPMENT has one approved drug.

There are eighteen US patents protecting SHIRE DEVELOPMENT drugs.

There are one hundred and forty-three patent family members on SHIRE DEVELOPMENT drugs in twenty-six countries.

Summary for Applicant: Shire Development

Patents:18
Tradenames:1
Ingredients:1
NDAs:1
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;ORAL021977-006Dec 10, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-003Feb 23, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-007Oct 30, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-003Feb 23, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-003Feb 23, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV activity for SHIRE DEVELOPMENT drugs

Drugname Dosage Strength Tradename Submissiondate
lisdexamfetamine dimesylate
Capsules20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
VYVANSE
2/23/2011

Non-Orange Book Patents for Shire Development

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
7,338,939Abuse-resistant hydrocodone compounds► Subscribe
6,716,452 Active agent delivery systems and methods for protecting and administering active agents► Subscribe
8,394,813Active agent delivery systems and methods for protecting and administering active agents► Subscribe
7,375,082Abuse-resistant hydrocodone compounds► Subscribe
8,106,016Compounds and compositions for prevention of overdose of oxycodone► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Shire Development Drugs

Country Document Number Estimated Expiration
South Korea20050098246► Subscribe
Japan2007507520► Subscribe
Australia2003216382► Subscribe
Japan2008535860► Subscribe
Japan2006516947► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Shire Development Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00043Denmark► SubscribePRODUCT 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
2013000079Germany► SubscribePRODUCT 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
90058-4Sweden► SubscribePRODUCT 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
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving 500+ biopharmaceutical companies globally:

Citi
Boehringer Ingelheim
Deloitte
Daiichi Sankyo
Express Scripts
Healthtrust
Argus Health
Fuji
McKinsey
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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