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Last Updated: June 1, 2020

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Shire Dev Llc Company Profile


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Summary for Shire Dev Llc
International Patents:248
US Patents:23
Tradenames:5
Ingredients:5
NDAs:5

Drugs and US Patents for Shire Dev Llc

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 7,662,788   Start Trial   Start Trial
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017 RX Yes Yes   Start Trial   Start Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-002 Jan 28, 2017 RX Yes No 7,723,305   Start Trial Y   Start Trial
Shire Dev Llc VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510-004 Jan 28, 2017 RX Yes No 7,687,467   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
>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 Dev Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017 RE41148   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 6,221,392   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 5,912,013   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 Sep 30, 1997 5,326,570   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 5,326,570   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SHIRE DEV LLC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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 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 Dev Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1644019 122013000079 Germany   Start 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
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
1644019 301019 Netherlands   Start Trial PRODUCT NAME: LISDEXAMFETAMINE, DESGEWENST IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDEZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 124498 20190528; FIRST REGISTRATION: GB PL 08081/0050-52 20130201
1644019 C01644019/01 Switzerland   Start Trial PRODUCT NAME: LISDEXAMPHETAMIN; REGISTRATION NO/DATE: SWISSMEDIC 63023 27.03.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Express Scripts
Medtronic
Dow
Mallinckrodt

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