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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Moodys
QuintilesIMS
Queensland Health
Citi
Dow
McKesson
Julphar
Deloitte

Generated: August 19, 2018

DrugPatentWatch Database Preview

Shire Company Profile

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Summary for Shire

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 Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-001 Jan 28, 2017 RX Yes No 7,678,771 ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-006 Jan 28, 2017 RX Yes Yes 7,662,788 ➤ Try a Free Trial ➤ Try a Free Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-003 Feb 23, 2007 RX Yes Yes 7,662,787 ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-002 Feb 23, 2007 RX Yes No 7,687,466 ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No 7,105,486 ➤ Try a Free Trial ➤ Try a Free Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-002 Feb 23, 2007 RX Yes No 7,723,305 ➤ Try a Free Trial Y ➤ Try a Free Trial
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 INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 5,854,290*PED ➤ Try a Free Trial
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 5,326,570 ➤ Try a Free Trial
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-002 Jun 19, 1990 3,740,395 ➤ Try a Free Trial
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-003 Jun 19, 1990 3,740,395 ➤ Try a Free Trial
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 Sep 30, 1997 5,326,570 ➤ Try a Free Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-001 Sep 2, 2009 5,854,290*PED ➤ Try a Free Trial
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 Extended-release Capsules 12.5 mg and 25 mg ➤ Subscribe 2017-08-07
➤ Subscribe Oral Powder 750 mg and 1000 mg ➤ Subscribe 2015-11-25
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 2015-08-25
➤ Subscribe Delayed-release Tablets 1.2 g ➤ Subscribe 2009-12-16
➤ Subscribe Extended-release Capsules 37.5 mg and50 mg ➤ Subscribe 2017-08-03
➤ Subscribe Chewable Tablet 500 mg, 750 mg and 1000 mg ➤ Subscribe 2008-10-27
➤ Subscribe Capsules 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg ➤ Subscribe 2011-02-23

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
7,338,939 Abuse-resistant hydrocodone compounds ➤ Try a Free Trial
8,378,105 Crystalline pharmaceutical and methods of preparation and use thereof ➤ Try a Free Trial
9,045,458 Compositions and methods for treatment ➤ Try a Free Trial
6,716,452 Active agent delivery systems and methods for protecting and administering active agents ➤ Try a Free Trial
8,394,813 Active agent delivery systems and methods for protecting and administering active agents ➤ Try a Free Trial
7,375,082 Abuse-resistant hydrocodone compounds ➤ Try a Free Trial
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
2008005 Lithuania ➤ Try a Free Trial PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
782 Luxembourg ➤ Try a Free Trial 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
/2008 Austria ➤ Try a Free Trial PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
90058-4 Sweden ➤ Try a Free Trial PRODUCT 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
2008005,C0817639 Lithuania ➤ Try a Free Trial PRODUCT 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
499 Luxembourg ➤ Try a Free Trial 91499, EXPIRES: 20141121
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.

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

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Daiichi Sankyo
Chubb
Medtronic
AstraZeneca
Johnson and Johnson
Federal Trade Commission
Argus Health
Boehringer Ingelheim

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.