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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Chubb
Federal Trade Commission
Moodys
Merck
McKesson
Daiichi Sankyo
Queensland Health
Cerilliant

Generated: April 26, 2018

DrugPatentWatch Database Preview

Shire Company Profile

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Summary for Shire
International Patents:523
US Patents:50
Tradenames:35
Ingredients:26
NDAs:39

Drugs and US Patents for Shire

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 021977-006 Dec 10, 2007 RX Yes No 7,655,630 ➤ Sign Up Y ➤ Sign Up
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-007 Oct 30, 2014 RX Yes No 7,678,771 ➤ Sign Up Y ➤ Sign Up
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-001 Feb 23, 2007 RX Yes No 7,659,254 ➤ Sign Up ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 AB RX Yes No 6,811,794*PED ➤ Sign Up 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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Expired US Patents for Shire

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 4,496,553 ➤ Sign Up
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 5,912,013 ➤ Sign Up
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 5,326,570 ➤ Sign Up
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 5,912,013 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for SHIRE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Capsules 100 mg and 200 mg ➤ Subscribe 2006-02-02
➤ Subscribe Extended-release Tablets 1 mg, 2 mg, 3 mg and 4 mg ➤ Subscribe 2009-12-29
➤ Subscribe Capsules 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg ➤ Subscribe 2011-02-23
➤ Subscribe Oral Powder 750 mg and 1000 mg ➤ Subscribe 2015-11-25
➤ Subscribe Extended-release Capsules 12.5 mg and 25 mg ➤ Subscribe 2017-08-07
➤ Subscribe Chewable Tablet 500 mg, 750 mg and 1000 mg ➤ Subscribe 2008-10-27
➤ Subscribe Delayed-release Tablets 1.2 g ➤ Subscribe 2009-12-16
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 2015-08-25
➤ Subscribe Extended-release Capsules 37.5 mg and50 mg ➤ Subscribe 2017-08-03

Non-Orange Book US 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
9,051,297 Compositions and methods for treatment ➤ Sign Up
9,708,303 LFA-1 inhibitor and methods of preparation and polymorph thereof ➤ Sign Up
7,427,600 Active agent delivery systems and methods for protecting and administering active agents ➤ Sign Up
7,375,082 Abuse-resistant hydrocodone compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Shire Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
782 Luxembourg ➤ Sign Up PRODUCT 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
C0002 France ➤ Sign Up PRODUCT 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
0359 Netherlands ➤ Sign Up 300359, 20091121, EXPIRES: 20141120
C/GB06/036 United Kingdom ➤ Sign Up SPC/GB06/036: 20061027
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Queensland Health
QuintilesIMS
Accenture
Boehringer Ingelheim
UBS
Argus Health
Daiichi Sankyo
Mallinckrodt

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.