Astellas Company Profile
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What is the competitive landscape for ASTELLAS, and when can generic versions of ASTELLAS drugs launch?
ASTELLAS has thirty-five approved drugs.
There are thirteen US patents protecting ASTELLAS drugs. There is one tentative approval on ASTELLAS drugs.
There are two hundred and eighty-three patent family members on ASTELLAS drugs in thirty-seven countries and sixty-seven supplementary protection certificates in nineteen countries.
Summary for Astellas
International Patents: | 283 |
US Patents: | 13 |
Tradenames: | 19 |
Ingredients: | 14 |
NDAs: | 35 |
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 | PROGRAF | tacrolimus | FOR SUSPENSION;ORAL | 210115-002 | May 24, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | |||||
Astellas | ARISTOCORT A | triamcinolone acetonide | CREAM;TOPICAL | 083015-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | |||||
Astellas | VESICARE LS | solifenacin succinate | SUSPENSION;ORAL | 209529-001 | May 26, 2020 | RX | Yes | Yes | 9,918,970 | See Plans and Pricing | Y | See Plans and Pricing | |||
Astellas | ARISTOCORT | triamcinolone | TABLET;ORAL | 011161-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | |||||
Astellas | PROGRAF | tacrolimus | CAPSULE;ORAL | 050708-001 | Apr 8, 1994 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | ||||
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-003 | Jun 27, 2006 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | ||||
>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 | AMBISOME | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 050740-001 | Aug 11, 1997 | 5,874,104 | See Plans and Pricing |
Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-002 | Jul 19, 2013 | 6,440,458 | See Plans and Pricing |
Astellas | MYCAMINE | micafungin sodium | INJECTABLE;INTRAVENOUS | 021506-002 | Mar 16, 2005 | 6,107,458 | See Plans and Pricing |
Astellas | LEXISCAN | regadenoson | SOLUTION;INTRAVENOUS | 022161-001 | Apr 10, 2008 | 6,403,567 | See Plans and Pricing |
Astellas | VESICARE | solifenacin succinate | TABLET;ORAL | 021518-001 | Nov 19, 2004 | 6,017,927*PED | See Plans and Pricing |
Astellas | ASTAGRAF XL | tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096-001 | Jul 19, 2013 | 6,440,458 | See Plans and Pricing |
>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 | 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 |
➤ 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 |
International Patents for Astellas Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Philippines | 12017502252 | See Plans and Pricing |
South Korea | 101332889 | See Plans and Pricing |
Japan | WO2010128659 | See Plans and Pricing |
Japan | 2016183200 | See Plans and Pricing |
Denmark | 3009428 | See Plans and Pricing |
Norway | 20076401 | See Plans and Pricing |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Astellas Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1189916 | 2011C/004 | Belgium | See Plans and Pricing | PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906 |
1280795 | 122016000011 | Germany | See Plans and Pricing | PRODUCT NAME: ISAVUCONAZONIUM ALS ISAVUCONAZONIUM-SULFAT ODER ALS SALZ MIT EINEM ANDEREN PHARMAZEUTISCH VERTRAEGLICHEN ANION, SOWIE HYDRATE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/15/1036 20151015 |
1893196 | 92338 | Luxembourg | See Plans and Pricing | PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625 |
1189916 | 2/2011 | Austria | See Plans and Pricing | PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 |
1893196 | 1390060-0 | Sweden | See Plans and Pricing | PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621 |
2428508 | C202030004 | Spain | See Plans and Pricing | PRODUCT NAME: GILTERITINIB O UNA SAL DEL MISMO NOMBRE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1399; DATE OF AUTHORISATION: 20191024; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1399; DATE OF FIRST AUTHORISATION IN EEA: 20191024 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.