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Last Updated: June 1, 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 TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-001 Aug 2, 2019 RX Yes Yes 9,169,250   Start Trial Y   Start Trial
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-002 Oct 2, 2015 RX Yes No 7,955,619   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 206316-002 Jan 8, 2015 RX Yes No   Start Trial   Start Trial
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-004 Oct 2, 2015 RX Yes Yes 7,955,619   Start Trial Y   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 Inc EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 4,855,290   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 5,624,963   Start Trial
Daiichi Sankyo TRIBENZOR amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 200175-001 Jul 23, 2010 5,616,599*PED   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride TABLET;ORAL 021176-001 May 26, 2000 5,693,675*PED   Start Trial
Daiichi Sankyo WELCHOL colesevelam hydrochloride CAPSULE;ORAL 021141-001 May 26, 2000 6,433,026*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 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
➤ 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

Supplementary Protection Certificates for Daiichi Sankyo Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 12C0033 France   Start Trial PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
1405852 CR 2015 00052 Denmark   Start Trial PRODUCT NAME: EDOXABAN, OR A SALT THEREOF, A SOLVATE THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
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 2015/045 Ireland   Start Trial PRODUCT NAME: EDOXABAN, A SALT THEREOF, A SOLVATIC THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
0503785 20/2009 Austria   Start Trial PRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Serving leading biopharmaceutical companies globally:

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