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Last Updated: February 17, 2020

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Daiichi Sankyo Company Profile


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Drugs and US Patents for Daiichi Sankyo

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-001 Oct 2, 2015 RX Yes No 7,955,619   Start Trial Y   Start Trial
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-001 Aug 2, 2019 RX Yes Yes 7,893,075   Start Trial Y   Start Trial
Daiichi Sankyo AZOR amlodipine besylate; olmesartan medoxomil TABLET;ORAL 022100-004 Sep 26, 2007 AB RX Yes Yes   Start Trial   Start Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-001 Jan 8, 2015 RX Yes No 7,365,205   Start Trial Y   Start Trial
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-001 Aug 2, 2019 RX Yes Yes 10,189,833   Start Trial   Start Trial
Daiichi Sankyo Inc SAVAYSA edoxaban tosylate TABLET;ORAL 206316-002 Jan 8, 2015 RX Yes No   Start Trial   Start Trial
>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 Daiichi Sankyo

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 7,101,960*PED   Start Trial
Daiichi Sankyo Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 5,580,880   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-001 Oct 2, 2009 6,066,678*PED   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride FOR SUSPENSION;ORAL 022362-002 Oct 2, 2009 5,607,669*PED   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 5,607,669*PED   Start Trial
Daiichi Sankyo TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175-001 Jul 23, 2010 5,616,599*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for DAIICHI SANKYO drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Powder for Oral Suspension 1.875 g/Packet and 3.75 g/Packet ➤ Subscribe 2010-04-09
➤ Subscribe Tablets 10 mg/20 mg and 5 mg/40 mg ➤ Subscribe 2008-03-31
➤ Subscribe Tablets 20 mg/12.5 mg ➤ Subscribe 2007-05-11
➤ Subscribe Capsules 30 mg ➤ Subscribe 2009-02-27
➤ Subscribe Tablets 15 mg, 30 mg and 60 mg ➤ Subscribe 2019-01-28
➤ Subscribe Tablets 625 mg ➤ Subscribe 2009-07-01
➤ Subscribe Tablets 5 mg/20 mg and 10 mg/40 mg ➤ Subscribe 2008-02-11
➤ Subscribe Tablets 5 mg, 20 mg and 40 mg ➤ Subscribe 2006-04-25
➤ Subscribe Tablets 40 mg/12.5 mg and 40 mg/25 mL ➤ Subscribe 2007-02-15
➤ Subscribe Tablets 15 mg, 30 mg, 60 mg and 100 mg ➤ Subscribe 2019-01-28

Supplementary Protection Certificates for Daiichi Sankyo Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1405852 15C0068 France   Start Trial PRODUCT NAME: EDOXABAN,UN SEL,SOLVATE OU N-OXYDE DE CELUI-CI,EN PARTICULIER L'EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993 20150619
0480717 98C0025 Belgium   Start Trial PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0502314 SPC/GB11/010 United Kingdom   Start Trial PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
1405852 1590052-5 Sweden   Start Trial PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE.; REG. NO/DATE: EU/1/15/993/001-028 20150623
1507558 2012/018 Ireland   Start Trial PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
1915993 300625 Netherlands   Start Trial PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Johnson and Johnson
McKesson
Boehringer Ingelheim
Moodys

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