CUBICIN Drug Patent Profile
✉ Email this page to a colleague
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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for CUBICIN?
- What are the global sales for CUBICIN?
- What is Average Wholesale Price for CUBICIN?
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: | 4,582 |
| 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 Centre/Research Institute of the McGill University Health Centre | Phase 4 |
| McGill University Health Center | Phase 4 |
Pharmacology for CUBICIN
| Drug Class | Lipopeptide Antibacterial |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cubist Pharms Llc | CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572-003 | Jul 6, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-001 | Sep 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-001 | Sep 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Argentina | 079127 | COMPOSICIONES DE DAPTOMICINA Y METODOS RELACIONADOS | ⤷ Sign Up |
| Portugal | 2504353 | ⤷ Sign Up | |
| European Patent Office | 3417849 | PROCÉDÉ DE PRÉPARATION D'UNE COMPOSITION DE DAPTOMYCINE SOLIDE (A PROCESS FOR PREPARING A SOLID DAPTOMYCIN COMPOSITION) | ⤷ Sign Up |
| Japan | 2013511557 | ⤷ Sign Up | |
| Poland | 416764 | ⤷ Sign Up | |
| Taiwan | I548414 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CUBICIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1115417 | 06C0022 | France | ⤷ Sign Up | PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119 |
| 1115417 | SPC/GB06/024 | United Kingdom | ⤷ Sign Up | 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 | CA 2006 00018 | Denmark | ⤷ Sign Up | PRODUCT NAME: DAPTOMYCIN |
| 1115417 | 300232 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), VERANDERING VAN DE JURIDISCHE ENTITEIT |
| 1115417 | 91254 | Luxembourg | ⤷ Sign Up | 91254, EXPIRES: 20210119 |
| 1115417 | SZ 22/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: DAPTOMYCIN |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
