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Last Updated: June 6, 2020

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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 Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-005 Jan 28, 2017 RX Yes No 7,678,771   Start Trial Y   Start Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-005 Dec 10, 2007 RX Yes No 7,687,466   Start Trial Y   Start Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-004 Jan 28, 2017 RX Yes No 7,713,936   Start Trial   Start Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-002 Jan 28, 2017 RX Yes No 7,105,486   Start Trial   Start Trial
Shire Development VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977-003 Feb 23, 2007 RX Yes Yes 7,678,771   Start Trial Y   Start Trial
Shire ADDERALL XR 30 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-003 Oct 11, 2001 AB RX Yes Yes   Start Trial   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

Paragraph IV (Patent) Challenges for SHIRE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ 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

Supplementary Protection Certificates for Shire Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0370453 C300359 Netherlands   Start Trial PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
0370453 SPC/GB09/002 United Kingdom   Start Trial PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
1613296 CR 2015 00042 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
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
1644019 C01644019/01 Switzerland   Start Trial PRODUCT NAME: LISDEXAMPHETAMIN; REGISTRATION NO/DATE: SWISSMEDIC 63023 27.03.2014
1644019 CA 2013 00043 Denmark   Start Trial 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
>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:

Moodys
Colorcon
Merck
Medtronic
Boehringer Ingelheim
Harvard Business School

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