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Serving leading biopharmaceutical companies globally:

Citi
Harvard Business School
Mallinckrodt
Express Scripts
Deloitte
Johnson and Johnson
Queensland Health
US Army
Baxter
Medtronic

Generated: February 19, 2018

DrugPatentWatch Database Preview

Shire Company Profile

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Summary for Shire
International Patents:511
US Patents:49
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 Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 RX Yes No 9,173,857 ➤ Sign Up ➤ Sign Up
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-006 Dec 10, 2007 RX Yes No 7,662,787 ➤ Sign Up Y ➤ Sign Up
Shire Llc FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-003 Nov 23, 2005 AB RX Yes No 7,465,465 ➤ Sign Up Y ➤ Sign Up
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-002 Jan 28, 2017 RX Yes No 7,713,936 ➤ Sign Up ➤ Sign Up
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-003 Jan 28, 2017 RX Yes No ➤ Sign Up ➤ Sign Up
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-003 Dec 24, 1991 DISCN No No ➤ Sign Up ➤ Sign Up
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-004 Dec 10, 2007 RX Yes No 7,718,619 ➤ Sign Up Y ➤ Sign Up
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 RX Yes No RE42096 ➤ Sign Up Y ➤ Sign Up
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 Sep 30, 1997 AB RX Yes No ➤ Sign Up ➤ Sign Up
Shire ADDERALL XR 15 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-006 May 22, 2002 AB RX Yes No RE42096*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 CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 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
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-001 Dec 24, 1991 4,244,946 ➤ Sign Up
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-002 Jun 19, 1990 3,740,395 ➤ Sign Up
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-001 Jun 19, 1990 3,864,487 ➤ Sign Up
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 5,326,570 ➤ Sign Up
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 4,496,553 ➤ Sign Up
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-001 Jun 19, 1990 3,740,395 ➤ Sign Up
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-004 Sep 2, 2009 5,854,290*PED ➤ Sign Up
Shire SUPPRELIN histrelin acetate INJECTABLE;INJECTION 019836-002 Dec 24, 1991 4,244,946 ➤ 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 12.5 mg and 25 mg ➤ Subscribe 8/7/2017
➤ Subscribe Extended-release Capsules 37.5 mg and50 mg ➤ Subscribe 8/3/2017
➤ Subscribe Oral Powder 750 mg and 1000 mg ➤ Subscribe 11/25/2015
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 8/25/2015
➤ Subscribe Capsules 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg ➤ Subscribe 2/23/2011
➤ Subscribe Extended-release Tablets 1 mg, 2 mg, 3 mg and 4 mg ➤ Subscribe 12/29/2009
➤ Subscribe Delayed-release Tablets 1.2 g ➤ Subscribe 12/16/2009
➤ Subscribe Chewable Tablet 500 mg, 750 mg and 1000 mg ➤ Subscribe 10/27/2008
➤ Subscribe Extended-release Capsules 100 mg and 200 mg ➤ Subscribe 2/2/2006

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
8,771,715 Compositions and methods for treatment ➤ Sign Up
8,758,776 Compositions and methods for treatment ➤ Sign Up
8,394,813 Active agent delivery systems and methods for protecting and administering active agents ➤ Sign Up
8,697,132 Capsule and powder formulations containing lanthanum compounds ➤ Sign Up
9,708,303 LFA-1 inhibitor and methods of preparation and polymorph thereof ➤ Sign Up
6,716,452 Active agent delivery systems and methods for protecting and administering active agents ➤ Sign Up
7,163,918 Iodothyronine compositions ➤ Sign Up
7,427,600 Active agent delivery systems and methods for protecting and administering active agents ➤ Sign Up
8,343,927 Pharmaceutical compositions for prevention of overdose or abuse ➤ Sign Up
8,071,617 Modulators of cellular adhesion ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for Shire Drugs

Supplementary Protection Certificates for Shire Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2008 Austria ➤ Sign Up PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
2013000079 Germany ➤ Sign Up PRODUCT 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
2008005,C0817639 Lithuania ➤ Sign Up 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 ➤ Sign Up 91499, EXPIRES: 20141121
C/GB06/036 United Kingdom ➤ Sign Up SPC/GB06/036: 20061027
2013 00043 Denmark ➤ Sign Up PRODUCT 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
2008005 Lithuania ➤ Sign Up PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
2015 00042 Denmark ➤ Sign Up PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
00359 Netherlands ➤ Sign Up PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
0359 Netherlands ➤ Sign Up 300359, 20091121, EXPIRES: 20141120
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:

Argus Health
Citi
Cantor Fitzgerald
Daiichi Sankyo
Queensland Health
Express Scripts
Moodys
Medtronic
Chinese Patent Office

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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