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Last Updated: February 7, 2023

CUBICIN Drug Patent Profile


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When do Cubicin patents expire, and when can generic versions of Cubicin launch?

Cubicin is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are two patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in CUBICIN is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cubicin

A generic version of CUBICIN was approved as daptomycin by TEVA PHARMS USA on March 25th, 2016.

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Drug patent expirations by year for CUBICIN
Drug Prices for CUBICIN

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Recent Clinical Trials for CUBICIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vancouver Island Health AuthorityPhase 4
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 4
McGill University Health CenterPhase 4

See all CUBICIN clinical trials

Pharmacology for CUBICIN

US Patents and Regulatory Information for CUBICIN

CUBICIN is protected by one US patents.

Patents protecting CUBICIN

Daptomycin for the treatment of biofilm and catheter salvage
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS

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 CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN RF daptomycin POWDER;INTRAVENOUS 021572-003 Jul 6, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing Y 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 CUBICIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-001 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc CUBICIN daptomycin POWDER;INTRAVENOUS 021572-002 Sep 12, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for CUBICIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Daptomycin Hospira daptomycin EMEA/H/C/004310
Daptomycin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised yes no no 2017-03-22
Merck Sharp & Dohme B.V. Cubicin daptomycin EMEA/H/C/000637
Cubicin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised no no no 2006-01-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CUBICIN

See the table below for patents covering CUBICIN around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2006130629 See Plans and Pricing
Japan 2013511557 See Plans and Pricing
Mexico 2012005993 COMPOSICIONES DE LIPOPEPTIDO Y METODOS RELACIONADOS. (LIPOPEPTIDE COMPOSITIONS AND RELATED METHODS.) See Plans and Pricing
European Patent Office 1674107 Utilisation de daptomycin (Use of daptomycin) See Plans and Pricing
Russian Federation 2004106569 See Plans and Pricing
Poland 348328 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CUBICIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1115417 22/2006 Austria See Plans and Pricing PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
1115417 SPC 018/2006 Ireland See Plans and Pricing SPC 018/2006: 20070523, EXPIRES: 20210118
1115417 300232 Netherlands See Plans and Pricing DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), VERANDERING VAN DE JURIDISCHE ENTITEIT
1115417 91254 Luxembourg See Plans and Pricing 91254, EXPIRES: 20210119
1115417 06C0022 France See Plans and Pricing PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417 SPC/GB06/024 United Kingdom See Plans and Pricing SUPPLEMENTARY 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.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKesson
Merck
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AstraZeneca

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 verification 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.