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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 Richwood	X-TROZINE	phendimetrazine tartrate	CAPSULE;ORAL	087394-001	Sep 22, 1982		DISCN	No	No
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-001	Jan 28, 2017		RX	Yes	No	7,671,030		Y
Shire Dev Llc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes	8,927,574		Y
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-001	Jun 19, 1990		DISCN	No	No

Expired US Patents for Shire

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	5,912,013
Shire	INTUNIV	guanfacine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022037-003	Sep 2, 2009	5,854,290*PED
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	5,326,570
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	5,912,013

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
	Capsules	20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg		2011-02-23
	Oral Powder	750 mg and 1000 mg		2015-11-25
	Extended-release Capsules	12.5 mg and 25 mg		2017-08-07
	Chewable Tablet	500 mg, 750 mg and 1000 mg		2008-10-27
	Delayed-release Tablets	1.2 g		2009-12-16
	Injection	10 mg/mL		2015-08-25
	Extended-release Capsules	37.5 mg and50 mg		2017-08-03

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
7,163,918	Iodothyronine compositions
7,338,939	Abuse-resistant hydrocodone compounds
7,375,082	Abuse-resistant hydrocodone compounds
6,716,452	Active agent delivery systems and methods for protecting and administering active agents

International Patents for Shire Drugs

Country	Document Number	Estimated Expiration
European Patent Office	1865980
Portugal	91692
European Patent Office	2316469
Hong Kong	1006716

Supplementary Protection Certificates for Shire Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2013000079	Germany		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
0359	Netherlands		300359, 20091121, EXPIRES: 20141120
/2016	Austria		PRODUCT NAME: LISDEXAMFETAMIN, OPTIONAL IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, INSBESONDERE EINES MESILAT-SALZES; NAT. REGISTRATION NO/DATE: 136851-136853 20160412; FIRST REGISTRATION: PL08081/0050-PL08081/0052 20130201

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