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Serving leading biopharmaceutical companies globally:

Argus Health
Healthtrust
QuintilesIMS
Accenture
Colorcon
Baxter
Chinese Patent Office
Covington
Mallinckrodt
Farmers Insurance

Generated: December 15, 2017

DrugPatentWatch Database Preview

Shire Dev Llc Company Profile

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

SHIRE DEV LLC has four approved drugs.

There are thirty-nine US patents protecting SHIRE DEV LLC drugs and there have been three Paragraph IV challenges on SHIRE DEV LLC drugs in the past three years.

There are three hundred and seventy-three patent family members on SHIRE DEV LLC drugs in forty-six countries and six supplementary protection certificates in five countries.

Summary for Shire Dev Llc

International Patents:373
US Patents:39
Tradenames:4
Ingredients:4
NDAs:4
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-001Jan 28, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-001Jan 28, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-006Jan 28, 2017RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-004Jan 28, 2017RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-004Jan 28, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-004Jan 28, 2017RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Shire Dev LlcMYDAYISamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL022063-003Jun 20, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-001Jan 28, 2017RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Shire Dev LlcMYDAYISamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL022063-003Jun 20, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcVYVANSElisdexamfetamine dimesylateTABLET, CHEWABLE;ORAL208510-002Jan 28, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV activity for SHIRE DEV LLC drugs

Drugname Dosage Strength Tradename Submissiondate
amphetamine aspartate;amphetamine sulfate;dextroamphetamine saccharate;dextroamphetamine sulfateExtended-release Capsules12.5 mg and 25 mgMYDAYIS8/7/2017
amphetamine aspartate;amphetamine sulfate;dextroamphetamine saccharate;dextroamphetamine sulfateExtended-release Capsules37.5 mg and50 mgMYDAYIS8/3/2017
lanthanum carbonateOral Powder750 mg and 1000 mgFOSRENOL11/25/2015
lisdexamfetamine dimesylateCapsules20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mgVYVANSE2/23/2011
lanthanum carbonateChewable Tablet500 mg, 750 mg and 1000 mgFOSRENOL10/27/2008

Non-Orange Book Patents for Shire Dev Llc

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
7,375,082Abuse-resistant hydrocodone compounds► Subscribe
6,322,819 Oral pulsed dose drug delivery system► Subscribe
8,394,813Active agent delivery systems and methods for protecting and administering active agents► Subscribe
7,381,428Stabilized lanthanum carbonate compositions► Subscribe
9,248,126Modulators of cellular adhesion► Subscribe
8,106,016Compounds and compositions for prevention of overdose of oxycodone► Subscribe
6,716,452 Active agent delivery systems and methods for protecting and administering active agents► Subscribe
9,708,303LFA-1 inhibitor and methods of preparation and polymorph thereof► Subscribe
8,378,105Crystalline pharmaceutical and methods of preparation and use thereof► Subscribe
7,375,083Pharmaceutical compositions for prevention of overdose or abuse► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Shire Dev Llc Drugs

Country Document Number Estimated Expiration
Japan2015187165► Subscribe
China101175488► Subscribe
Eurasian Patent Organization200500530► Subscribe
Canada2536959► Subscribe
European Patent Office1311242► Subscribe
Canada2420590► Subscribe
Japan2009514940► Subscribe
Hong Kong1095815► Subscribe
Australia8659901► Subscribe
World Intellectual Property Organization (WIPO)2012075194► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Shire Dev Llc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00043Denmark► SubscribePRODUCT 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
2013000079Germany► SubscribePRODUCT 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
2008005Lithuania► SubscribePRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319
2008005,C0817639Lithuania► SubscribePRODUCT 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
90058-4Sweden► SubscribePRODUCT 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
C/GB06/036United Kingdom► SubscribeSPC/GB06/036: 20061027
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Argus Health
Harvard Business School
Covington
Fuji
McKinsey
Boehringer Ingelheim
Johnson and Johnson
Express Scripts
Chubb

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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