Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Novartis
Federal Trade Commission
McKesson
Chubb
Healthtrust
Daiichi Sankyo
US Department of Justice
QuintilesIMS
Covington

Generated: October 22, 2017

DrugPatentWatch Database Preview

Shire Company Profile

« Back to Dashboard

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

There are five hundred and sixteen patent family members on SHIRE drugs in fifty-five countries and fourteen supplementary protection certificates in nine countries.

Summary for Applicant: Shire

International Patents:516
US Patents:49
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
DOPAR
levodopa
TABLET;ORAL016913-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Shire Dev Llc
VYVANSE
lisdexamfetamine dimesylate
TABLET, CHEWABLE;ORAL208510-003Jan 28, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-004Dec 10, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-007Oct 30, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-005Dec 10, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-004Dec 10, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire Dev Llc
MYDAYIS
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL022063-004Jun 20, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Shire
DOPAR
levodopa
CAPSULE;ORAL016913-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Shire Development
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL021977-004Dec 10, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Shire Dev Llc
VYVANSE
lisdexamfetamine dimesylate
TABLET, CHEWABLE;ORAL208510-001Jan 28, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Shire

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-002Sep 30, 1997► Subscribe► Subscribe
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993► Subscribe► Subscribe
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-002Sep 2, 2009► Subscribe► Subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 1997► Subscribe► Subscribe
Shire
SUPPRELIN
histrelin acetate
INJECTABLE;INJECTION019836-002Dec 24, 1991► Subscribe► Subscribe
Shire
INTUNIV
guanfacine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022037-003Sep 2, 2009► Subscribe► Subscribe
Shire
ETHMOZINE
moricizine hydrochloride
TABLET;ORAL019753-002Jun 19, 1990► 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
ETHMOZINE
moricizine hydrochloride
TABLET;ORAL019753-002Jun 19, 1990► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
7,169,752Compounds and compositions for prevention of overdose of oxycodone► Subscribe
9,248,126Modulators of cellular adhesion► Subscribe
9,045,458Compositions and methods for treatment► Subscribe
8,343,927Pharmaceutical compositions for prevention of overdose or abuse► Subscribe
9,708,303LFA-1 inhibitor and methods of preparation and polymorph thereof► Subscribe
6,716,452 Active agent delivery systems and methods for protecting and administering active agents► Subscribe
7,375,083Pharmaceutical compositions for prevention of overdose or abuse► Subscribe
9,051,297Compositions and methods for treatment► Subscribe
8,394,813Active agent delivery systems and methods for protecting and administering active agents► Subscribe
7,427,600Active agent delivery systems and methods for protecting and administering active agents► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Shire Drugs

Country Document Number Estimated Expiration
Japan2009514940► Subscribe
German Democratic Republic297169► Subscribe
Eurasian Patent Organization012798► Subscribe
Norway911649► Subscribe
China103237543► Subscribe
Israel174683► Subscribe
Turkey200200561► Subscribe
Germany60335807► Subscribe
Mexico2015001098► Subscribe
Australia2003216382► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Shire Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008005Lithuania► SubscribePRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
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/GB06/036United Kingdom► SubscribeSPC/GB06/036: 20061027
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
/2008Austria► SubscribePRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 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
2015 00042Denmark► SubscribePRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
499Luxembourg► Subscribe91499, EXPIRES: 20141121
782Luxembourg► SubscribePRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Similar Applicant Names

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

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Deloitte
Chinese Patent Office
Medtronic
Boehringer Ingelheim
Chubb
Harvard Business School
Healthtrust
Citi

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot