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Serving leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Chubb
Deloitte
McKinsey
Federal Trade Commission
Mallinckrodt
UBS
Johnson and Johnson
Julphar

Generated: December 14, 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-six patent family members on CUBIST drugs in forty-three countries and thirty-five supplementary protection certificates in twelve countries.

Summary for Cubist

International Patents:256
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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms LlcCUBICINdaptomycinPOWDER;IV (INFUSION)021572-001Sep 12, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Cubist Pharms LlcSIVEXTROtedizolid phosphatePOWDER;IV (INFUSION)205436-001Jun 20, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Cubist Pharms LlcZERBAXAceftolozane sulfate; tazobactam sodiumPOWDER;IV (INFUSION)206829-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Cubist Pharms LlcSIVEXTROtedizolid phosphateTABLET;ORAL205435-001Jun 20, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Cubist Pharms LlcSIVEXTROtedizolid phosphatePOWDER;IV (INFUSION)205436-001Jun 20, 2014RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Cubist Pharms LlcSIVEXTROtedizolid phosphateTABLET;ORAL205435-001Jun 20, 2014RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Cubist Pharms LlcZERBAXAceftolozane sulfate; tazobactam sodiumPOWDER;IV (INFUSION)206829-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Cubist Pharms LlcSIVEXTROtedizolid phosphateTABLET;ORAL205435-001Jun 20, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Cubist PharmsENTEREGalvimopanCAPSULE;ORAL021775-001May 20, 2008RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Cubist PharmsENTEREGalvimopanCAPSULE;ORAL021775-001May 20, 2008RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Cubist

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

Drugname Dosage Strength Tradename Submissiondate
alvimopanCapsules12 mgENTEREG6/16/2017
fidaxomicinTablets200 mgDIFICID5/27/2015
daptomycinFor Injection500 mg/vialCUBICIN11/19/2008

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
7,696,220Methods for the treatment or inhibition of ileus► Subscribe
9,044,485Ceftolozane antibiotic compositions► Subscribe
9,163,043Oxazolidinone derivatives► Subscribe
8,728,796Tiacumicin production► Subscribe
9,662,397Lipopeptide compositions and related methods► Subscribe
8,835,382Lipopeptide compositions and related methods► Subscribe
8,883,986Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof► 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
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
China101982468► Subscribe
China104056250► Subscribe
Peru17172015► Subscribe
World Intellectual Property Organization (WIPO)2014144295► Subscribe
New Zealand712289► Subscribe
Israel219891► Subscribe
Japan2012197309► Subscribe
Taiwan200626585► Subscribe
Cuba20110155► Subscribe
China101128114► 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
C0028France► SubscribePRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
0727Netherlands► SubscribePRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
2015 00020Denmark► SubscribePRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
90003-7Sweden► SubscribePRODUCT NAME: CEFTOLOZAN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SPECIELLT ETT SVAVELSYRASALT; REG. NO/DATE: EU/1/15/1032 20150918
2016 00004Denmark► SubscribePRODUCT NAME: CEFTOLOZAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT ET SVOVLSYRESALT; REG. NO/DATE: EU/1/15/1032/001 20150922
15/048Ireland► SubscribePRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/991 20150323
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
C/GB06/024United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB06/024 GRANTED TO CUBIST PHARMACEUTICALS, INC IN RESPECT OF THE PRODUCT DAPTOMYCIN, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6162 DATED 27 JUNE 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22 JANUARY 2021.
22/2006Austria► SubscribePRODUCT NAME: DAPTOMYCIN
1539977/01Switzerland► SubscribePRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: SWISSMEDIC 62957 01.05.2014
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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:

Harvard Business School
Boehringer Ingelheim
Healthtrust
Chubb
Merck
Mallinckrodt
Cantor Fitzgerald
Moodys
Teva
UBS

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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