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Daptomycin - Generic Drug Details
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What are the generic drug sources for daptomycin and what is the scope of patent protection?
Daptomycin
is the generic ingredient in three branded drugs marketed by Cubist Pharms Llc, Accord Hlthcare, Be Pharms, Dr Reddys, Fresenius Kabi Usa, Hospira Inc, Jiangsu Hengrui Med, Mylan Labs Ltd, Sagent Pharms Inc, Teva Pharms Usa, and Xellia Pharms Aps, and is included in sixteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Daptomycin has forty-eight patent family members in thirty-one countries.
There are ten drug master file entries for daptomycin. Sixteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for daptomycin
International Patents: | 48 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 11 |
NDAs: | 16 |
Drug Master File Entries: | 10 |
Suppliers / Packagers: | 16 |
Bulk Api Vendors: | 40 |
Clinical Trials: | 81 |
Patent Applications: | 7,060 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for daptomycin |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for daptomycin |
What excipients (inactive ingredients) are in daptomycin? | daptomycin excipients list |
DailyMed Link: | daptomycin at DailyMed |
Recent Clinical Trials for daptomycin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital, Caen | Phase 1 |
Vancouver Island Health Authority | Phase 4 |
Instituto de Salud Carlos III | Phase 4 |
Generic filers with tentative approvals for DAPTOMYCIN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 350MG/VIAL | POWDER;INTRAVENOUS |
Start Trial | Start Trial | 350MG/VIAL | POWDER;IV (INFUSION) |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for daptomycin
Drug Class | Lipopeptide Antibacterial |
Medical Subject Heading (MeSH) Categories for daptomycin
Paragraph IV (Patent) Challenges for DAPTOMYCIN
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 daptomycin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sagent Pharms Inc | DAPTOMYCIN | daptomycin | POWDER;IV (INFUSION) | 208385-001 | Sep 12, 2017 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Jiangsu Hengrui Med | DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 212022-001 | Aug 22, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Sagent Pharms Inc | DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 207104-001 | Nov 15, 2019 | AP | RX | No | No | 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 |
Expired US Patents for daptomycin
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 | 021572-001 | 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 |
International Patents for daptomycin
Country | Patent Number | Estimated Expiration |
---|---|---|
Cyprus | 1120854 | Start Trial |
Chile | 2012001336 | Start Trial |
Croatia | P20181380 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for daptomycin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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. |
1115417 | 06C0022 | France | Start Trial | PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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