COLISTIMETHATE SODIUM - Generic Drug Details
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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 Adrastea Pharma, Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, Xellia Pharms Aps, and Endo Operations, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for colistimethate sodium. Five suppliers are listed for this compound.
Summary for COLISTIMETHATE SODIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 15 |
Clinical Trials: | 20 |
Drug Prices: | Drug price trends for COLISTIMETHATE SODIUM |
What excipients (inactive ingredients) are in COLISTIMETHATE SODIUM? | COLISTIMETHATE SODIUM excipients list |
DailyMed Link: | COLISTIMETHATE SODIUM at DailyMed |
Recent Clinical Trials for COLISTIMETHATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Southeast University, China | N/A |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Phase 3 |
Zambon SpA | Phase 3 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Xellia Pharms Aps | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 205356-001 | May 29, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Endo Operations | COLY-MYCIN M | colistimethate sodium | INJECTABLE;INJECTION | 050108-002 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 065364-001 | Apr 17, 2008 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Adrastea Pharma | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 064216-001 | Feb 26, 1999 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
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