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Details for New Drug Application (NDA): 021572
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NDA 021572 describes CUBICIN RF, which is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CUBICIN RF profile page.
The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 021572
| Tradename: | CUBICIN RF |
| Applicant: | Cubist Pharms Llc |
| Ingredient: | daptomycin |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021572
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572 | NDA AUTHORIZED GENERIC | Teva Parenteral Medicines, Inc. | 0703-0125 | 0703-0125-01 | 1 VIAL, SINGLE-USE in 1 CARTON (0703-0125-01) > 10 mL in 1 VIAL, SINGLE-USE |
| CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572 | NDA AUTHORIZED GENERIC | Teva Parenteral Medicines, Inc. | 0703-0125 | 0703-0125-01 | 1 VIAL, SINGLE-USE in 1 CARTON (0703-0125-01) > 10 mL in 1 VIAL, SINGLE-USE |
Paragraph IV (Patent) Challenges for 021572
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CUBICIN RF | POWDER;INTRAVENOUS | daptomycin | 021572 | 2008-11-19 |
| CUBICIN | POWDER;INTRAVENOUS | daptomycin | 021572 | 2008-11-19 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 250MG/VIAL | ||||
| Approval Date: | Sep 12, 2003 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
| Approval Date: | Sep 12, 2003 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Mar 29, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Sep 1, 2020 | ||||||||
| Regulatory Exclusivity Use: | PROVIDES FOR LABELING CHANGES REGARDING THE USE OF DAPTOMYCIN IN THE PEDIATRIC POPULATION FOR STAPHYLOCOCCUS AUREUS BACTEREMIA (SAB) BASED ON RESULTS OF A TRIAL IN PEDIATRIC PATIENTS 1 TO 17 YEARS OF AGE | ||||||||
Expired US Patents for NDA 021572
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | Start Trial | Start Trial |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | Start Trial | Start Trial |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-001 | Sep 12, 2003 | Start Trial | Start Trial |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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