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

Serving leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Healthtrust
Deloitte
Cipla
Moodys
AstraZeneca
Johnson and Johnson
Accenture
Federal Trade Commission

Generated: December 11, 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 four Paragraph IV challenges on SHIRE drugs in the past three years.

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

Summary for Shire

International Patents:512
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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-006Jan 28, 2017RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Shire DevelopmentVYVANSElisdexamfetamine dimesylateCAPSULE;ORAL021977-007Oct 30, 2014RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire RichwoodX-TROZINEphendimetrazine tartrateTABLET;ORAL086551-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Shire DevelopmentVYVANSElisdexamfetamine dimesylateCAPSULE;ORAL021977-001Feb 23, 2007RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
ShireADDERALL XR 30amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL021303-003Oct 11, 2001ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Shire LlcFOSRENOLlanthanum carbonateTABLET, CHEWABLE;ORAL021468-001Oct 26, 2004DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcXIIDRAlifitegrastSOLUTION/DROPS;OPHTHALMIC208073-001Jul 11, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Shire DevelopmentVYVANSElisdexamfetamine dimesylateCAPSULE;ORAL021977-002Feb 23, 2007RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-003Jan 28, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire DevelopmentVYVANSElisdexamfetamine dimesylateCAPSULE;ORAL021977-003Feb 23, 2007RXYesYes► Subscribe► 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
ShireINTUNIVguanfacine hydrochlorideTABLET, EXTENDED RELEASE;ORAL022037-002Sep 2, 2009► Subscribe► Subscribe
ShirePENTASAmesalamineCAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993► Subscribe► Subscribe
ShireETHMOZINEmoricizine hydrochlorideTABLET;ORAL019753-002Jun 19, 1990► Subscribe► Subscribe
ShireETHMOZINEmoricizine hydrochlorideTABLET;ORAL019753-003Jun 19, 1990► Subscribe► Subscribe
ShireETHMOZINEmoricizine hydrochlorideTABLET;ORAL019753-002Jun 19, 1990► Subscribe► Subscribe
ShireETHMOZINEmoricizine hydrochlorideTABLET;ORAL019753-001Jun 19, 1990► Subscribe► Subscribe
ShireINTUNIVguanfacine hydrochlorideTABLET, EXTENDED RELEASE;ORAL022037-001Sep 2, 2009► Subscribe► Subscribe
ShireCARBATROLcarbamazepineCAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 1997► Subscribe► Subscribe
ShireETHMOZINEmoricizine hydrochlorideTABLET;ORAL019753-003Jun 19, 1990► Subscribe► Subscribe
ShirePENTASAmesalamineCAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993► 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
amphetamine aspartate;amphetamine sulfate;dextroamphetamine saccharate;dextroamphetamine sulfateExtended-release Capsules12.5 mg and 25 mgMYDAYIS8/7/2017
amphetamine aspartate;amphetamine sulfate;dextroamphetamine saccharate;dextroamphetamine sulfateExtended-release Capsules37.5 mg and50 mgMYDAYIS8/3/2017
lanthanum carbonateOral Powder750 mg and 1000 mgFOSRENOL11/25/2015
icatibantInjection10 mg/mLFIRAZYR8/25/2015
lisdexamfetamine dimesylateCapsules20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mgVYVANSE2/23/2011
guanfacine hydrochlorideExtended-release Tablets1 mg, 2 mg, 3 mg and 4 mgINTUNIV12/29/2009
mesalamineDelayed-release Tablets1.2 gLIALDA12/16/2009
lanthanum carbonateChewable Tablet500 mg, 750 mg and 1000 mgFOSRENOL10/27/2008
carbamazepineExtended-release Capsules100 mg and 200 mgCARBATROL2/2/2006

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
9,045,457Compositions and methods for treatment► Subscribe
8,871,935Crystalline pharmaceutical and methods of preparation and use thereof► Subscribe
7,375,082Abuse-resistant hydrocodone compounds► Subscribe
8,080,562Crystalline pharmaceutical and methods of preparation and use thereof► Subscribe
8,758,776Compositions and methods for treatment► Subscribe
8,133,881Carbohydrate conjugates to prevent abuse of controlled substances► 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
8,263,119Capsule formulations containing lanthanum compounds► Subscribe
8,071,617Modulators of cellular adhesion► 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
Cyprus1115392► Subscribe
Canada2536959► Subscribe
Denmark1198226► Subscribe
World Intellectual Property Organization (WIPO)0076481► Subscribe
Australia2004266050► Subscribe
Israel163667► Subscribe
SloveniaEP1542660► Subscribe
Hong Kong1095815► Subscribe
China101175488► Subscribe
China1049505► 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
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
C/GB06/036United Kingdom► SubscribeSPC/GB06/036: 20061027
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
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
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
2015 00042Denmark► SubscribePRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
2008005Lithuania► SubscribePRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
499Luxembourg► Subscribe91499, EXPIRES: 20141121
C/GB09/002United Kingdom► SubscribePRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
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:

Accenture
Fuji
AstraZeneca
Federal Trade Commission
Deloitte
US Department of Justice
Merck
Chinese Patent Office
QuintilesIMS
McKesson

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:

botpot