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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Teva
Novartis
Accenture
Farmers Insurance
Moodys
Fuji
Mallinckrodt
Johnson and Johnson

Generated: December 12, 2017

DrugPatentWatch Database Preview

Astellas Company Profile

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What is the competitive landscape for ASTELLAS, and what generic alternatives to ASTELLAS drugs are available?

ASTELLAS has thirty-one approved drugs.

There are thirty US patents protecting ASTELLAS drugs on ASTELLAS drugs in the past three years.

There are three hundred and eighty patent family members on ASTELLAS drugs in forty-two countries and forty-seven supplementary protection certificates in fourteen countries.

Summary for Astellas

International Patents:380
US Patents:30
Tradenames:17
Ingredients:13
NDAs:31
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AstellasCEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINERceftizoxime sodiumINJECTABLE;INJECTION050589-001Oct 3, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AstellasASTAGRAF XLtacrolimusCAPSULE, EXTENDED RELEASE;ORAL204096-002Jul 19, 2013RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
AstellasARISTOCORTtriamcinoloneTABLET;ORAL011161-010Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AstellasPROGRAFtacrolimusCAPSULE;ORAL050708-001Apr 8, 1994ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
AstellasCEFIZOXceftizoxime sodiumINJECTABLE;INJECTION050560-002Sep 15, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AstellasCRESEMBAisavuconazonium sulfatePOWDER;IV (INFUSION)207501-001Mar 6, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AstellasPROGRAFtacrolimusINJECTABLE;INJECTION050709-001Apr 8, 1994APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AstellasARISTOCORT Atriamcinolone acetonideCREAM;TOPICAL083017-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AstellasASTAGRAF XLtacrolimusCAPSULE, EXTENDED RELEASE;ORAL204096-001Jul 19, 2013RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
AstellasLEXISCANregadenosonSOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Astellas

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-002Mar 16, 2005► Subscribe► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-003Jun 27, 2006► Subscribe► Subscribe
AstellasCYCLOCORTamcinonideCREAM;TOPICAL018116-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
AstellasADENOSCANadenosineSOLUTION;IV (INFUSION)020059-001May 18, 1995► Subscribe► Subscribe
AstellasADENOSCANadenosineSOLUTION;IV (INFUSION)020059-002May 18, 1995► Subscribe► Subscribe
AstellasADENOSCANadenosineSOLUTION;IV (INFUSION)020059-001May 18, 1995► Subscribe► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-002Mar 16, 2005► Subscribe► Subscribe
AstellasADENOCARDadenosineINJECTABLE;INJECTION019937-002Oct 30, 1989► Subscribe► Subscribe
AstellasPROGRAFtacrolimusINJECTABLE;INJECTION050709-001Apr 8, 1994► Subscribe► Subscribe
AstellasAMBISOMEamphotericin bINJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997► Subscribe► Subscribe
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Paragraph IV activity for ASTELLAS drugs

Drugname Dosage Strength Tradename Submissiondate
enzalutamideCapsules40 mgXTANDI8/31/2016
micafungin sodiumFor Injection50 mg/vial and 100 mg/vialMYCAMINE6/16/2014
tacrolimusExtended-release Capsules0.5 mg, 1 mg, and 5 mgASTAGRAF XL11/15/2013
regadenosonInjection0.08 mg/mL, 5 mL vialLEXISCAN4/10/2012
solifenacin succinateTablets5 mg and 10 mgVESICARE4/8/2009
adenosineInjection3 mg/mL, 20 mL and 30 mL vialsADENOSCAN4/18/2005
adenosineInjection3 mg/mL, 20 mL and 30 mL vialsADENOSCAN4/16/2005

Non-Orange Book Patents for Astellas

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
8,071,566Methods of coronary imaging► Subscribe
8,906,878Myocardial perfusion imaging methods and compositions► Subscribe
6,770,290 Amphotericin B liposome preparation► Subscribe
8,648,105Diarylthiohydantoin compounds► Subscribe
7,732,595Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs► Subscribe
7,112,565Stabilized pharmaceutical composition in lyophilized form► Subscribe
8,524,883Monohydrate of (1-{9-[4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopu- rin-2-yl}pyrazol-4-yl)-N-methylcarboxamide► Subscribe
9,163,057Methods of myocardial perfusion imaging► Subscribe
7,151,182Intermediates for N-substituted carbamoyloxyalkyl-azolium derivatives► Subscribe
7,671,192Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs► 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 Astellas Drugs

Country Document Number Estimated Expiration
Mexico2010014060► Subscribe
Canada2388320► Subscribe
Norway2011002► Subscribe
Norway2005016► Subscribe
China1315865► Subscribe
Mexico9702531► Subscribe
Australia752265► Subscribe
Norway20083395► Subscribe
Taiwan200306867► Subscribe
South Africa200200301► 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 Astellas Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/036United Kingdom► SubscribePRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
C0032France► SubscribePRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
15/073Ireland► SubscribePRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
13/061Ireland► SubscribePRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
452Luxembourg► Subscribe91452, EXPIRES: 20200929
2014000122Germany► SubscribePRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
0801067/01Switzerland► SubscribePRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
2011 00005Denmark► Subscribe
C014/2004Ireland► SubscribeSPC014/2004: 20050803, EXPIRES: 20181215
0352Netherlands► Subscribe300352, 20150929, EXPIRES: 20200928
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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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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Dow
Cerilliant
Julphar
US Department of Justice
Merck
Federal Trade Commission
Boehringer Ingelheim
Novartis

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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