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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
McKesson
Medtronic
Dow
Moodys

Last Updated: November 20, 2019

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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 Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-005 Dec 10, 2007 RX Yes No 7,662,787   Start Trial Y   Start Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-007 Oct 30, 2014 RX Yes No   Start Trial   Start Trial
Shire ADDERALL XR 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-005 May 22, 2002 AB RX Yes No RE41148*PED   Start Trial   Start Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-006 Jan 28, 2017 RX Yes Yes 7,223,735   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Shire

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire ADDERALL XR 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-004 May 22, 2002 RE41148*PED   Start Trial
Shire ETHMOZINE moricizine hydrochloride TABLET;ORAL 019753-002 Jun 19, 1990 3,740,395   Start Trial
Shire ADDERALL XR 30 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-003 Oct 11, 2001 6,322,819*PED   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 6,221,392   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SHIRE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 2015-08-25
➤ Subscribe Extended-release Tablets 1 mg, 2 mg, 3 mg and 4 mg ➤ Subscribe 2009-12-29
➤ 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
➤ Subscribe Delayed-release Tablets 1.2 g ➤ Subscribe 2009-12-16
➤ Subscribe Extended-release Capsules 100 mg and 200 mg ➤ Subscribe 2006-02-02
➤ 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

Supplementary Protection Certificates for Shire Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0370453 09C0002 France   Start 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
1644019 CR 2013 00043 Denmark   Start Trial PRODUCT NAME: LISDEXAMFETAMIN, EVENTUELT I FORM AF ET MESYLAT ELLER HYDROCHLORID SALT DERAF; NAT. REG. NO/DATE: MT499080, MT499081, MT499082 20130214; FIRST REG. NO/DATE: PL PL 08081/0050-0052 20130201
0370453 91499 Luxembourg   Start Trial 91499, EXPIRES: 20141121
1644019 SPC/GB13/052 United Kingdom   Start Trial PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Express Scripts
Baxter
Johnson and Johnson
Moodys

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