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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Accenture
Covington
AstraZeneca
Moodys
UBS
Deloitte
Express Scripts
Merck

Generated: June 20, 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 Richwood X-TROZINE phendimetrazine tartrate CAPSULE;ORAL 087394-001 Sep 22, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-001 Jan 28, 2017 RX Yes No 7,671,030 ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire Dev Llc XIIDRA lifitegrast SOLUTION/DROPS;OPHTHALMIC 208073-001 Jul 11, 2016 RX Yes Yes 8,927,574 ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-001 Jun 19, 1990 DISCN No No ➤ Try a Free Trial ➤ 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 CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 5,912,013 ➤ Try a Free Trial
Shire INTUNIV guanfacine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022037-003 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 CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 5,912,013 ➤ 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 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
7,163,918 Iodothyronine compositions ➤ Try a Free Trial
7,338,939 Abuse-resistant hydrocodone compounds ➤ Try a Free Trial
7,375,082 Abuse-resistant hydrocodone compounds ➤ Try a Free Trial
6,716,452 Active agent delivery systems and methods for protecting and administering active agents ➤ 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
C0002 France ➤ Try a Free Trial 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
2013000079 Germany ➤ Try a Free Trial 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
0359 Netherlands ➤ Try a Free Trial 300359, 20091121, EXPIRES: 20141120
/2016 Austria ➤ Try a Free Trial PRODUCT NAME: LISDEXAMFETAMIN, OPTIONAL IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, INSBESONDERE EINES MESILAT-SALZES; NAT. REGISTRATION NO/DATE: 136851-136853 20160412; FIRST REGISTRATION: PL08081/0050-PL08081/0052 20130201
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:

Federal Trade Commission
Chubb
Argus Health
Healthtrust
Teva
Citi
AstraZeneca
Medtronic
Daiichi Sankyo

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.