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CUBICIN RF Drug Profile
» See Plans and Pricing
Which patents cover Cubicin Rf, and when can generic versions of Cubicin Rf launch?
Cubicin Rf is a drug marketed by Cubist Pharms Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has forty-five patent family members in thirty-one countries.
The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
US ANDA Litigation and Generic Entry Outlook for Cubicin Rf
A generic version of CUBICIN RF was approved as daptomycin by HOSPIRA INC on September 12th, 2014.
Summary for CUBICIN RF
| International Patents: | 45 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 9 |
| Patent Applications: | 3,346 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CUBICIN RF |
| DailyMed Link: | CUBICIN RF at DailyMed |
Recent Clinical Trials for CUBICIN RF
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vancouver Island Health Authority | Phase 4 |
| Poitiers University Hospital | Phase 3 |
| University Hospital Inselspital, Berne | Phase 1 |
Pharmacology for CUBICIN RF
| Drug Class | Lipopeptide Antibacterial |
Paragraph IV (Patent) Challenges for CUBICIN RF
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CUBICIN RF | POWDER;INTRAVENOUS | daptomycin | 021572 | 2008-11-19 |
| CUBICIN | POWDER;INTRAVENOUS | daptomycin | 021572 | 2008-11-19 |
US Patents and Regulatory Information for CUBICIN RF
| 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 RF | daptomycin | POWDER;INTRAVENOUS | 021572-003 | Jul 6, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cubist Pharms Llc | CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572-003 | Jul 6, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cubist Pharms Llc | CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572-003 | Jul 6, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for CUBICIN RF
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1109846 | Start Trial |
| Czech Republic | 305004 | Start Trial |
| Israel | 219889 | Start Trial |
| Peru | 20151717 | Start Trial |
| Hong Kong | 1085746 | Start Trial |
| South Africa | 200205763 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CUBICIN RF
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1115417 | SZ 22/2006 | Austria | Start Trial | PRODUCT NAME: DAPTOMYCIN |
| 1115417 | SPC 018/2006 | Ireland | Start Trial | SPC 018/2006: 20070523, EXPIRES: 20210118 |
| 1115417 | 300232 | Netherlands | Start Trial | DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), VERANDERING VAN DE JURIDISCHE ENTITEIT |
| 1115417 | 91254 | Luxembourg | Start Trial | 91254, EXPIRES: 20210119 |
| 1115417 | 22/2006 | Austria | Start Trial | PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119 |
| 1115417 | SPC/GB06/024 | United Kingdom | Start 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. |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
