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 Adrastea Pharma, Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, and Xellia Pharms Aps. 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. Five 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 ADRASTEA PHARMA on February 26th, 1999.
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Questions you can ask:
- What is the 5 year forecast for COLISTIMETHATE SODIUM?
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- What is Average Wholesale Price for COLISTIMETHATE SODIUM?
Summary for COLISTIMETHATE SODIUM
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 15 |
| Clinical Trials: | 20 |
| 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adrastea Pharma | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 064216-001 | Feb 26, 1999 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nexus | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 065177-001 | Mar 19, 2004 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Avet Lifesciences | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 202359-001 | Sep 28, 2012 | AP | RX | No | No | ⤷ 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 | |||
| Xellia Pharms Aps | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 205356-001 | May 29, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sagent Pharms Inc | COLISTIMETHATE SODIUM | colistimethate sodium | INJECTABLE;INJECTION | 201365-001 | Feb 19, 2014 | 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 |
