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Shire Company Profile

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What is the competitive landscape for SHIRE, and when can generic versions of SHIRE drugs launch?

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 Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-001	Jan 28, 2017		RX	Yes	No	7,678,771		Y
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-006	Jan 28, 2017		RX	Yes	Yes	7,662,788
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-003	Feb 23, 2007		RX	Yes	Yes	7,662,787			Y
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-002	Feb 23, 2007		RX	Yes	No	7,687,466		Y
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-006	Dec 10, 2007		RX	Yes	No	7,105,486
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-002	Feb 23, 2007		RX	Yes	No	7,723,305		Y

Expired US Patents for Shire

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-004	Sep 2, 2009	5,854,290*PED
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	5,326,570
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-002	Jun 19, 1990	3,740,395
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-003	Jun 19, 1990	3,740,395
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	5,326,570
Shire	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-001	Sep 2, 2009	5,854,290*PED

Paragraph IV (Patent) Challenges for SHIRE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

Non-Orange Book US Patents for Shire

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,338,939	Abuse-resistant hydrocodone compounds
8,378,105	Crystalline pharmaceutical and methods of preparation and use thereof
9,045,458	Compositions and methods for treatment
6,716,452	Active agent delivery systems and methods for protecting and administering active agents
8,394,813	Active agent delivery systems and methods for protecting and administering active agents
7,375,082	Abuse-resistant hydrocodone compounds

International Patents for Shire Drugs

Country	Document Number	Estimated Expiration
European Patent Office	2209371
Russian Federation	2081880
Denmark	1644019
European Patent Office	2316468
Australia	2009201552
Canada	2367042

Supplementary Protection Certificates for Shire Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2008005	Lithuania		PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
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
/2008	Austria		PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
90058-4	Sweden		PRODUCT NAME: LISDEXAMFETAMIN VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT, SAERSKILT ETT MESYLATSALT; NAT. REG. NO/DATE: 47382 20130722; FIRST REG.: GB PL 08081/0050-52 20130201
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
499	Luxembourg		91499, EXPIRES: 20141121

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
• Shire Llc
• Shire Orphan Therap