Cubicin Drug Patent Profile
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When do Cubicin patents expire, and what generic alternatives are available?
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-seven 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.
Summary for Cubicin
International Patents: | 3 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 48 |
Clinical Trials: | 40 |
Patent Applications: | 3,997 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Cubicin |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Cubicin |
What excipients (inactive ingredients) are in Cubicin? | Cubicin excipients list |
DailyMed Link: | Cubicin at DailyMed |
Recent Clinical Trials for Cubicin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Vancouver Island Health Authority | Phase 4 |
McGill University Health Center | Phase 4 |
McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 4 |
Pharmacology for Cubicin
Drug Class | Lipopeptide Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cubist Pharms Llc | CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572-003 | Jul 6, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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
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 |
---|---|---|---|
Croatia | P20181380 | ⤷ Try a Trial | |
Austria | 322280 | ⤷ Try a Trial | |
Hong Kong | 1217205 | ⤷ Try a Trial | |
Russian Federation | 2002122114 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2006130629 | ⤷ Try a Trial | |
Cyprus | 1109846 | ⤷ Try a Trial | |
Hong Kong | 1217204 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Cubicin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1115417 | 91254 | Luxembourg | ⤷ Try a Trial | 91254, EXPIRES: 20210119 |
1115417 | 22/2006 | Austria | ⤷ Try a Trial | PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119 |
1115417 | SPC/GB06/024 | United Kingdom | ⤷ Try a Trial | 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. |
1115417 | 06C0022 | France | ⤷ Try a Trial | PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119 |
1115417 | CA 2006 00018 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DAPTOMYCIN |
1115417 | SPC 018/2006 | Ireland | ⤷ Try a Trial | SPC 018/2006: 20070523, EXPIRES: 20210118 |
1115417 | 300232 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), VERANDERING VAN DE JURIDISCHE ENTITEIT |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |