COLISTIMETHATE SODIUM Drug Patent Profile
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Which patents cover Colistimethate Sodium, and what generic alternatives are available?
Colistimethate Sodium is a drug marketed by Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, Xellia Pharms Aps, and Xgen Pharms. and is included in six NDAs.
The generic ingredient in COLISTIMETHATE SODIUM is colistimethate sodium. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Colistimethate Sodium
A generic version of COLISTIMETHATE SODIUM was approved as colistimethate sodium by XGEN PHARMS on February 26th, 1999.
Summary for COLISTIMETHATE SODIUM
US Patents: | 0 |
Applicants: | 6 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 15 |
Clinical Trials: | 18 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for COLISTIMETHATE SODIUM |
DailyMed Link: | COLISTIMETHATE SODIUM at DailyMed |
Recent Clinical Trials for COLISTIMETHATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zambon SpA | Phase 3 |
Belarusian State Medical University | Phase 4 |
Minsk State Clinical Hospital No 9 | Phase 4 |
Pharmacology for COLISTIMETHATE SODIUM
Drug Class | Polymyxin-class Antibacterial |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sagent Pharms Inc | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 201365-001 | Feb 19, 2014 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Fresenius Kabi Usa | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 065364-001 | Apr 17, 2008 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Nexus | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 065177-001 | Mar 19, 2004 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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/001225 Colobreathe 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 |