colistimethate sodium - Profile
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What are the generic sources for colistimethate sodium and what is the scope of freedom to operate?
Colistimethate sodium
is the generic ingredient in two branded drugs marketed by Avet Lifesciences, Fresenius Kabi Usa, Nexus, Pharmobedient, Sagent Pharms Inc, Xellia Pharms Aps, and Ph Health, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.Summary for colistimethate sodium
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 7 |
US Patents and Regulatory Information for colistimethate sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avet Lifesciences | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 202359-001 | Sep 28, 2012 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Fresenius Kabi Usa | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 065364-001 | Apr 17, 2008 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Nexus | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 065177-001 | Mar 19, 2004 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Pharmobedient | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 064216-001 | Feb 26, 1999 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Sagent Pharms Inc | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 201365-001 | Feb 19, 2014 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Xellia Pharms Aps | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 205356-001 | May 29, 2015 | AP | RX | No | 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 |
EU/EMA Drug Approvals for colistimethate sodium
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Teva B.V. | Colobreathe | colistimethate sodium | EMEA/H/C/001225Colobreathe is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged six years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents. | Authorised | no | no | no | 2012-02-13 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
