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Serving leading biopharmaceutical companies globally:

Queensland Health
Accenture
Citi
US Army
Farmers Insurance
Chinese Patent Office
Cantor Fitzgerald
QuintilesIMS
Mallinckrodt
Deloitte

Generated: October 22, 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 seventy-seven patent family members on ASTELLAS drugs in forty-two countries and forty-five supplementary protection certificates in fourteen countries.

Summary for Applicant: Astellas

International Patents:377
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 Product Substance Delist Req. Exclusivity Expiration
Astellas
ARISTOCORT A
triamcinolone acetonide
CREAM;TOPICAL083015-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Astellas
XTANDI
enzalutamide
CAPSULE;ORAL203415-001Aug 31, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Astellas
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER
ceftizoxime sodium
INJECTABLE;INJECTION050589-002Oct 3, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe
Astellas
ASTAGRAF XL
tacrolimus
CAPSULE, EXTENDED RELEASE;ORAL204096-003Jul 19, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Astellas
CRESEMBA
isavuconazonium sulfate
POWDER;IV (INFUSION)207501-001Mar 6, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Astellas
ARISTOCORT
triamcinolone acetonide
OINTMENT;TOPICAL080750-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Astellas
ARISTOCORT
triamcinolone
TABLET;ORAL011161-009Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
Astellas
ARISTOCORT
triamcinolone acetonide
CREAM;TOPICAL083017-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Astellas

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas
PROGRAF
tacrolimus
INJECTABLE;INJECTION050709-001Apr 8, 1994► Subscribe► Subscribe
Astellas
ADENOCARD
adenosine
INJECTABLE;INJECTION019937-002Oct 30, 1989► Subscribe► Subscribe
Astellas
MYCAMINE
micafungin sodium
INJECTABLE;IV (INFUSION)021506-002Mar 16, 2005► Subscribe► Subscribe
Astellas
ADENOSCAN
adenosine
SOLUTION;IV (INFUSION)020059-001May 18, 1995► Subscribe► Subscribe
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997► Subscribe► Subscribe
Astellas
MYCAMINE
micafungin sodium
INJECTABLE;IV (INFUSION)021506-003Jun 27, 2006► Subscribe► Subscribe
Astellas
ADENOSCAN
adenosine
SOLUTION;IV (INFUSION)020059-002May 18, 1995► Subscribe► Subscribe
Astellas
CYCLOCORT
amcinonide
CREAM;TOPICAL018116-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Astellas
CYCLOCORT
amcinonide
OINTMENT;TOPICAL018498-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Astellas
ADENOSCAN
adenosine
SOLUTION;IV (INFUSION)020059-001May 18, 1995► Subscribe► Subscribe
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Paragraph IV activity for ASTELLAS drugs

Drugname Dosage Strength Tradename Submissiondate
enzalutamide
Capsules40 mg
XTANDI
8/31/2016
micafungin sodium
For Injection50 mg/vial and 100 mg/vial
MYCAMINE
6/16/2014
tacrolimus
Extended-release Capsules0.5 mg, 1 mg, and 5 mg
ASTAGRAF XL
11/15/2013
regadenoson
Injection0.08 mg/mL, 5 mL vial
LEXISCAN
4/10/2012
solifenacin succinate
Tablets5 mg and 10 mg
VESICARE
4/8/2009
adenosine
Injection3 mg/mL, 20 mL and 30 mL vials
ADENOSCAN
4/18/2005
adenosine
Injection3 mg/mL, 20 mL and 30 mL vials
ADENOSCAN
4/16/2005

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
8,524,883Monohydrate 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
8,569,260N-pyrazole A.sub.2A receptor agonists► Subscribe
8,071,566Methods of coronary imaging► Subscribe
6,770,290 Amphotericin B liposome preparation► Subscribe
7,112,565Stabilized pharmaceutical composition in lyophilized form► Subscribe
8,648,105Diarylthiohydantoin compounds► Subscribe
8,268,988Process for preparing an A2A-adenosine receptor agonist and its polymorphs► Subscribe
7,151,182Intermediates for N-substituted carbamoyloxyalkyl-azolium derivatives► Subscribe
7,956,179Process for preparing an A2A-adenosine receptor agonist and its polymorphs► 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
Norway341071► Subscribe
Germany69529844► Subscribe
Japan6013535► Subscribe
China1167709► Subscribe
China101076343► Subscribe
Turkey200201205► Subscribe
Japan2005538190► Subscribe
Serbia53967► Subscribe
South Africa200004963► Subscribe
China1171109► 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
2013029,C1893196Lithuania► SubscribePRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
338Luxembourg► SubscribePRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
C004/2011Ireland► SubscribeSPC004/2011: 20110719, EXPIRES: 20250620
1893196/01Switzerland► SubscribePRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC 63040 03.12.2013
2011000010Germany► SubscribePRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
C0028France► SubscribePRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
90060-0Sweden► SubscribePRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
2013000155Germany► SubscribePRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
785Luxembourg► Subscribe91785, EXPIRES: 20250621
2004 00037Denmark► Subscribe
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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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Mallinckrodt
Chinese Patent Office
Colorcon
Cipla
Medtronic
Federal Trade Commission
Johnson and Johnson
US Army

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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