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Shire Company Profile

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SHIRE has thirty-nine approved drugs.

There are thirty-three US patents protecting SHIRE drugs.

There are four hundred and four patent family members on SHIRE drugs in fifty-two countries and seventeen supplementary protection certificates in eleven countries.

International Patents:	404
US Patents:	33
Tradenames:	35
Ingredients:	26
NDAs:	39
Patent Litigation for Shire:	See patent lawsuits for Shire
PTAB Cases with Shire as patent owner:	See PTAB cases with Shire as patent owner

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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	7,659,253	Start Trial	Y	Y		Start Trial
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-006	Jan 28, 2017		RX	Yes	Yes	7,659,254	Start Trial				Start Trial
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-007	Oct 30, 2014		RX	Yes	No	7,678,771	Start Trial	Y			Start Trial
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-004	Dec 10, 2007		RX	Yes	No	7,718,619	Start Trial	Y			Start Trial
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-003	Jan 28, 2017		RX	Yes	No	7,687,466	Start Trial	Y			Start Trial
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-003	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001	RE41148*PED	Start Trial
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017	RE41148	Start Trial
Shire	ADDERALL XR 5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-005	May 22, 2002	6,605,300*PED	Start Trial
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-001	Jun 20, 2017	RE41148	Start Trial
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017	RE42096	Start Trial
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-003	Jun 19, 1990	3,864,487	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Injection	10 mg/mL	➤ Subscribe	2015-08-25

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Country	Patent Number	Estimated Expiration
African Intellectual Property Organization (OAPI)	13075	Start Trial
China	105943554	Start Trial
Portugal	1287822	Start Trial
Peru	20070821	Start Trial
Slovakia	490689	Start Trial
Israel	226020	Start Trial
>Country	>Patent Number	>Estimated Expiration

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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
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	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
0370453	51/2008	Austria	Start Trial	PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 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
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

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