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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Covington
Colorcon
Daiichi Sankyo
McKesson
Deloitte
Dow
Moodys
Harvard Business School
Healthtrust

Generated: September 20, 2017

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Shionogi Company Profile

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

SHIONOGI has nine approved drugs.

There are nine US patents protecting SHIONOGI drugs on SHIONOGI drugs in the past three years.

There are eighty patent family members on SHIONOGI drugs in twenty-four countries.

Summary for Applicant: Shionogi

Patents:9
Tradenames:9
Ingredients:8
NDAs:9
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi Inc
COGNEX
tacrine hydrochloride
CAPSULE;ORAL020070-002Sep 9, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Shionogi Inc
SYMPROIC
naldemedine tosylate
TABLET;ORAL208854-001Mar 23, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Shionogi Inc
ULESFIA
benzyl alcohol
LOTION;TOPICAL022129-001Apr 9, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Shionogi Inc
SYMPROIC
naldemedine tosylate
TABLET;ORAL208854-001Mar 23, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Shionogi Inc
SYMPROIC
naldemedine tosylate
TABLET;ORAL208854-001Mar 23, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Shionogi Inc
COGNEX
tacrine hydrochloride
CAPSULE;ORAL020070-004Sep 9, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Shionogi Inc
COGNEX
tacrine hydrochloride
CAPSULE;ORAL020070-003Sep 9, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Shionogi Inc
DORIBAX
doripenem
INJECTABLE;IV (INFUSION)022106-001Oct 12, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Shionogi
UROPLUS SS
sulfamethoxazole; trimethoprim
TABLET;ORAL071815-001Sep 28, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Shionogi Inc
COGNEX
tacrine hydrochloride
CAPSULE;ORAL020070-001Sep 9, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Shionogi

Paragraph IV activity for SHIONOGI drugs

Drugname Dosage Strength Tradename Submissiondate
benzyl alcohol
Lotion5%
ULESFIA
4/11/2016
doripenem
Injection250 mg/vial and 500 mg/vial
DORIBAX
10/11/2011

Non-Orange Book Patents for Shionogi

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
9,221,823Crystal form of pyrrolidylthiocarbapenem derivative► Subscribe
8,084,4606,7-unsaturated-7-carbamoyl substituted morphinan derivative► Subscribe
9,464,094Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same► Subscribe
9,315,512Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same► Subscribe
9,296,756Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same► Subscribe
8,536,1926,7-unsaturated-7-carbamoyl substituted morphinan derivative► 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 Shionogi Drugs

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2012063933► Subscribe
Spain2525215► Subscribe
European Patent Office1003484► Subscribe
Mexico338392► Subscribe
China1309374► Subscribe
MexicoPA02009592► Subscribe
European Patent Office2639234► Subscribe
Taiwan201300392► Subscribe
Russian Federation2607084► Subscribe
Austria304014► 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 Shionogi Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0041France► SubscribePRODUCT NAME: CYCLO((4R)-4(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-) : PASIREOTIDE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/753/001 20120424
C/GB04/012United Kingdom► SubscribePRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
C/GB01/002United Kingdom► SubscribePRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
C/GB12/030United Kingdom► SubscribePRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
0528678/01Switzerland► SubscribePRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009
C/GB01/003United Kingdom► SubscribePRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
C/GB09/006United Kingdom► SubscribePRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
C0005France► SubscribePRODUCT NAME: DORIPENEME; REGISTRATION NO/DATE IN FRANCE: EU/1/07/467/001 DU 20080725; REGISTRATION NO/DATE AT EEC: EU/1/08/467/001 DU 20080725
00374Netherlands► SubscribePRODUCT NAME: DORIPENEM; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
09/002Ireland► SubscribePRODUCT NAME: DORIPENEM.; REGISTRATION NO/DATE: EU/1/08/467/001 20080725
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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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Harvard Business School
Daiichi Sankyo
Boehringer Ingelheim
US Army
AstraZeneca
Chinese Patent Office
Fuji
Citi

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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