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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
McKesson
Medtronic
Cantor Fitzgerald
Federal Trade Commission
Covington
Novartis
Citi
Harvard Business School
AstraZeneca

Generated: August 21, 2017

DrugPatentWatch Database Preview

Shire Company Profile

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What is the competitive landscape for SHIRE, and when can generic versions of SHIRE drugs launch?

SHIRE has thirty-nine approved drugs.

There are forty-four US patents protecting SHIRE drugs and there have been two Paragraph IV challenges on SHIRE drugs in the past three years.

There are four hundred and seventy-one patent family members on SHIRE drugs in forty-eight countries.

Summary for Applicant: Shire

Patents:44
Tradenames:35
Ingredients:26
NDAs:39
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-004Sep 2, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-005Dec 10, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-004Dec 10, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-004Dec 10, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-002Sep 2, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Shire

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-002Sep 2, 2009► Subscribe► Subscribe
Shire
SUPPRELIN
histrelin acetate
INJECTABLE;INJECTION019836-002Dec 24, 1991► Subscribe► Subscribe
Shire
SUPPRELIN
histrelin acetate
INJECTABLE;INJECTION019836-003Dec 24, 1991► Subscribe► Subscribe
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993► Subscribe► Subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 1997► Subscribe► Subscribe
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Paragraph IV activity for SHIRE drugs

Drugname Dosage Strength Tradename Submissiondate
lanthanum carbonate
Oral Powder750 mg and 1000 mg
FOSRENOL
11/25/2015
icatibant
Injection10 mg/mL
FIRAZYR
8/25/2015
lisdexamfetamine dimesylate
Capsules20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
VYVANSE
2/23/2011
guanfacine hydrochloride
Extended-release Tablets1 mg, 2 mg, 3 mg and 4 mg
INTUNIV
12/29/2009
mesalamine
Delayed-release Tablets1.2 g
LIALDA
12/16/2009
lanthanum carbonate
Chewable Tablet500 mg, 750 mg and 1000 mg
FOSRENOL
10/27/2008
carbamazepine
Extended-release Capsules100 mg and 200 mg
CARBATROL
2/2/2006

Non-Orange Book Patents for Shire

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
9,051,297Compositions and methods for treatment► Subscribe
8,758,776Compositions and methods for treatment► Subscribe
8,106,016Compounds and compositions for prevention of overdose of oxycodone► Subscribe
7,375,083Pharmaceutical compositions for prevention of overdose or abuse► Subscribe
7,427,600Active agent delivery systems and methods for protecting and administering active agents► 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 Drugs

Country Document Number Estimated Expiration
Spain2099102► Subscribe
Australia2009201958► Subscribe
Hong Kong1085669► Subscribe
ItalyMI991316► Subscribe
European Patent Office0413277► 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 Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008005,C0817639Lithuania► SubscribePRODUCT NAME: LANTANO KARBONATO HIDRATAS; NAT. REGISTRATION NO/DATE: LT/1/07/0776/001-021 20071003; FIRST REGISTRATION: 17192, 2004-03-19 ; 18466, 2004-03-19; 21073, 2004-10-19; 21074 20041029
C0002France► SubscribePRODUCT NAME: ICATIBANT, EVENTUELLEMENT SOUS FORME DE SEL PHYSIOLOGIQUEMENT ACCEPTABLE, NOTAMMENT L?ACETATE D?ICATIBANT; REGISTRATION NO/DATE IN FRANCE: EU/1/08/461/001 DU 20080711; REGISTRATION NO/DATE AT EEC: EU/1/08/461/001 DU 20080711
C/GB09/002United Kingdom► SubscribePRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
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
00359Netherlands► SubscribePRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
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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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Daiichi Sankyo
Queensland Health
Accenture
Boehringer Ingelheim
Cantor Fitzgerald
QuintilesIMS
Medtronic
Colorcon
Argus Health

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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