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Last Updated: January 27, 2020

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Astellas Company Profile

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Summary for Astellas
International Patents:410
US Patents:31
Tradenames:18
Ingredients:14
NDAs:33
Patent Litigation for Astellas: See patent lawsuits for Astellas

Drugs and US Patents for Astellas

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas XTANDI enzalutamide CAPSULE;ORAL 203415-001 Aug 31, 2012 RX Yes Yes 7,709,517   Start Trial Y Y   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 AP RX Yes Yes 6,774,104*PED   Start Trial Y   Start Trial
Astellas ARISTOCORT triamcinolone diacetate SYRUP;ORAL 011960-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-002 Nov 19, 2004 AB RX Yes Yes 6,017,927*PED   Start Trial   Start Trial
Astellas CEFIZOX ceftizoxime sodium INJECTABLE;INJECTION 050560-005 Mar 19, 1993 DISCN No 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 Astellas

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas VESICARE solifenacin succinate TABLET;ORAL 021518-002 Nov 19, 2004 6,017,927*PED   Start Trial
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 5,965,156   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 6,440,458   Start Trial
Astellas CYCLOCORT amcinonide OINTMENT;TOPICAL 018498-001 Approved Prior to Jan 1, 1982 4,158,055   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 6,440,458   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ASTELLAS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Capsules 0.5 mg, 1 mg, and 5 mg ➤ Subscribe 2013-11-15
➤ Subscribe For Injection 50 mg/vial and 100 mg/vial ➤ Subscribe 2014-06-16
➤ Subscribe Injection 3 mg/mL, 20 mL and 30 mL vials ➤ Subscribe 2005-04-16
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2009-04-08
➤ Subscribe Capsules 40 mg ➤ Subscribe 2016-08-31
➤ Subscribe Injection 3 mg/mL, 20 mL and 30 mL vials ➤ Subscribe 2005-04-18
➤ Subscribe Injection 0.08 mg/mL, 5 mL vial ➤ Subscribe 2012-04-10

Supplementary Protection Certificates for Astellas Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0801067 SPC014/2004 Ireland   Start Trial SPC014/2004: 20050803, EXPIRES: 20181215
1189916 C01189916/01 Switzerland   Start Trial PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1280795 92939 Luxembourg   Start Trial PRODUCT NAME: ISAVUCONBAZOLE EN TANT QUE SULFATE D'ISAVUCONAZONIUM OU EN TANT QUE SEL D'ISAVUCONAZONIUM AVEC TOUT AUTRE ANION PHARMACEUTIQUEMENT ACCEPTABLE, OPTIONNELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151019
1893196 SPC/GB13/079 United Kingdom   Start Trial PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1189916 1190003-2.L Sweden   Start Trial PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
>Patent Number >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.

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Johnson and Johnson
Harvard Business School
Merck
Baxter

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