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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Covington
Daiichi Sankyo
QuintilesIMS
Baxter
McKinsey
Deloitte
AstraZeneca
Argus Health

Generated: October 18, 2017

DrugPatentWatch Database Preview

Cubist Company Profile

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What is the competitive landscape for CUBIST, and when can generic versions of CUBIST drugs launch?

CUBIST has six approved drugs.

There are twenty US patents protecting CUBIST drugs and there have been two Paragraph IV challenges on CUBIST drugs in the past three years.

There are two hundred and fifty-five patent family members on CUBIST drugs in forty-two countries and thirty-one supplementary protection certificates in eleven countries.

Summary for Applicant: Cubist

International Patents:255
US Patents:20
Tradenames:6
Ingredients:5
NDAs:6
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms Llc
ZERBAXA
ceftolozane sulfate; tazobactam sodium
POWDER;IV (INFUSION)206829-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Cubist Pharms Llc
ZERBAXA
ceftolozane sulfate; tazobactam sodium
POWDER;IV (INFUSION)206829-001Dec 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Cubist Pharms Llc
SIVEXTRO
tedizolid phosphate
TABLET;ORAL205435-001Jun 20, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cubist Pharms Llc
SIVEXTRO
tedizolid phosphate
TABLET;ORAL205435-001Jun 20, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cubist Pharms Llc
SIVEXTRO
tedizolid phosphate
POWDER;IV (INFUSION)205436-001Jun 20, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003APRXYesYes► Subscribe► Subscribe► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
Cubist Pharms Llc
SIVEXTRO
tedizolid phosphate
TABLET;ORAL205435-001Jun 20, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Cubist Pharms Llc
SIVEXTRO
tedizolid phosphate
POWDER;IV (INFUSION)205436-001Jun 20, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Cubist

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 2003► Subscribe► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;IV (INFUSION)021572-001Sep 12, 2003► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003► Subscribe► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008► Subscribe► Subscribe
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003► Subscribe► Subscribe
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Paragraph IV activity for CUBIST drugs

Drugname Dosage Strength Tradename Submissiondate
alvimopan
Capsules12 mg
ENTEREG
6/16/2017
fidaxomicin
Tablets200 mg
DIFICID
5/27/2015
daptomycin
For Injection500 mg/vial
CUBICIN
11/19/2008

Non-Orange Book Patents for Cubist

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
8,883,986Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof► Subscribe
7,696,220Methods for the treatment or inhibition of ileus► Subscribe
9,662,397Lipopeptide compositions and related methods► Subscribe
8,835,382Lipopeptide compositions and related methods► Subscribe
9,044,485Ceftolozane antibiotic compositions► Subscribe
8,518,899Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof► Subscribe
9,624,250Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5- -hydroxymethyl oxazolidin-2-one dihydrogen phosphate► Subscribe
8,728,796Tiacumicin production► Subscribe
9,163,043Oxazolidinone derivatives► Subscribe
7,507,564Tiacumicin production► 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 Cubist Drugs

Country Document Number Estimated Expiration
European Patent Office1848273► Subscribe
Australia2005327308► Subscribe
SloveniaEP1539977► Subscribe
Portugal1556389► Subscribe
South Korea20050061271► Subscribe
Canada2776682► Subscribe
European Patent Office1765312► Subscribe
South Korea20170040371► Subscribe
Costa Rica20110464► Subscribe
Philippines12014500092► 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 Cubist Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00048Denmark► SubscribePRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TEDIZOLID PHOSPHATE; REG. NO/DATE: EU/1/15/991 20150325
2015032Lithuania► SubscribePRODUCT NAME: TEDIZOLIDO FOSFATAS; REGISTRATION NO/DATE: EU/1/15/991 20150323
943Luxembourg► SubscribePRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 20150922
0727Netherlands► SubscribePRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
0762Netherlands► SubscribePRODUCT NAME: TEDIZOLID, DESGEWENST IN DE VORM VAN EEN ESTER, IN HET BIJZONDER EEN FOSFAAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/991 20150323
2015000078Germany► SubscribePRODUCT NAME: TEDIZOLID, GEGEBENENFALLS IN FORM EINES ESTERS, INSBESONDERE EINES PHOSPHATS, ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/991/001-003 20150323
C0022France► SubscribePRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
0759Netherlands► SubscribePRODUCT NAME: TEDIZOLID, DESGEWENST IN DE VORM VAN EEN ESTER, IN HET BIJZONDER EEN FOSFAAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/991 20150323
3 50021-2015Slovakia► SubscribePRODUCT NAME: TEDIZOLIDFOSFAT; REGISTRATION NO/DATE: EU/1/15/991/001 - EU/1/15/991/003 20150325
2016 00004Denmark► SubscribePRODUCT NAME: CEFTOLOZAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT ET SVOVLSYRESALT; REG. NO/DATE: EU/1/15/1032/001 20150922
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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:

McKinsey
Covington
Fuji
Dow
Medtronic
Fish and Richardson
Julphar
Cerilliant
Merck
Daiichi Sankyo

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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