Serving hundreds of leading biopharmaceutical companies globally:

Generated: October 17, 2018

DrugPatentWatch Database Preview

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.

Summary for Shire

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

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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 Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-003	Jan 28, 2017		RX	Yes	No	7,223,735	➤ Sign Up	Y			➤ Sign Up
Shire Dev Llc	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-005	Jan 28, 2017		RX	Yes	No	7,223,735	➤ Sign Up	Y			➤ Sign Up
Shire Development	VYVANSE	lisdexamfetamine dimesylate	CAPSULE;ORAL	021977-002	Feb 23, 2007		RX	Yes	No	7,718,619	➤ Sign Up	Y			➤ Sign Up
Shire Dev Llc	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes	9,023,397	➤ Sign Up	Y			➤ Sign Up
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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	6,221,392	➤ Sign Up
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-001	Jun 19, 1990	3,864,487	➤ Sign Up
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991	4,244,946	➤ Sign Up
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	5,326,570	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for SHIRE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Delayed-release Tablets	1.2 g	➤ Subscribe	2009-12-16
➤ 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	Extended-release Capsules	100 mg and 200 mg	➤ Subscribe	2006-02-02
➤ Subscribe	Extended-release Tablets	1 mg, 2 mg, 3 mg and 4 mg	➤ Subscribe	2009-12-29
➤ 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

International Patents for Shire Drugs

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Country	Document Number	Estimated Expiration
New Zealand	303260	➤ Sign Up
China	103237543	➤ Sign Up
Australia	2003240949	➤ Sign Up
Luxembourg	91499	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for Shire Drugs

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
782	Luxembourg	➤ Sign Up	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
499	Luxembourg	➤ Sign Up	91499, EXPIRES: 20141121
90058-4	Sweden	➤ Sign Up	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
00359	Netherlands	➤ Sign Up	PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Similar Applicant Names

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

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo

Citi

Express Scripts

Fuji

Merck

Federal Trade Commission

QuintilesIMS

Julphar

Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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