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Shire Company Profile

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What is the competitive landscape for SHIRE, and what generic alternatives to SHIRE drugs are available?

SHIRE has thirty-nine approved drugs.

There are fifty US patents protecting SHIRE drugs.

There are five hundred and twenty-three patent family members on SHIRE drugs in fifty-five countries and sixteen supplementary protection certificates in ten countries.

Summary for Shire

International Patents:	523
US Patents:	50
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

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	ADDERALL XR 30	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-003	Oct 11, 2001	AB	RX	Yes	Yes	6,605,300*PED				Y
Shire Richwood	X-TROZINE	phendimetrazine tartrate	TABLET;ORAL	086551-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-003	Feb 23, 2007		RX	Yes	Yes
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-001	Jan 28, 2017		RX	Yes	No	7,662,787			Y

Expired US Patents for Shire

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	5,912,013
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-003	Jun 19, 1990	3,864,487
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-001	Jun 20, 2017	RE41148
Shire Llc	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	5,968,976

Paragraph IV (Patent) Challenges for SHIRE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Chewable Tablet	500 mg, 750 mg and 1000 mg		2008-10-27
	Capsules	20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg		2011-02-23
	Extended-release Capsules	100 mg and 200 mg		2006-02-02
	Extended-release Tablets	1 mg, 2 mg, 3 mg and 4 mg		2009-12-29
	Extended-release Capsules	12.5 mg and 25 mg		2017-08-07
	Oral Powder	750 mg and 1000 mg		2015-11-25
	Injection	10 mg/mL		2015-08-25
	Delayed-release Tablets	1.2 g		2009-12-16
	Extended-release Capsules	37.5 mg and50 mg		2017-08-03

International Patents for Shire Drugs

Country	Document Number	Estimated Expiration
Russian Federation	2015102926
Australia	2006247136
South Korea	101159477
China	1042918

Supplementary Protection Certificates for Shire Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00359	Netherlands		PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
C0002	France		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
2008005,C0817639	Lithuania		PRODUCT NAME: LANTANO KARBONATO HIDRATAS; NAT. REGISTRATION NO/DATE: LT/1/07/0776/001-021 20071003; FIRST REGISTRATION: 17192, 2004-03-19 ; 18466, 2004-03-19; 21073, 2004-10-19; 21074 20041029
782	Luxembourg		PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Shire
• Shire Dev Llc
• Shire Development
• Shire Human Genetic