COLY-MYCIN M Drug Patent Profile
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When do Coly-mycin M patents expire, and what generic alternatives are available?
Coly-mycin M is a drug marketed by Endo Operations and is included in one NDA.
The generic ingredient in COLY-MYCIN M 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 Coly-mycin M
A generic version of COLY-MYCIN M 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 COLY-MYCIN M?
- What are the global sales for COLY-MYCIN M?
- What is Average Wholesale Price for COLY-MYCIN M?
Summary for COLY-MYCIN M
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 18 |
| Patent Applications: | 6 |
| DailyMed Link: | COLY-MYCIN M at DailyMed |
Pharmacology for COLY-MYCIN M
| Drug Class | Polymyxin-class Antibacterial |
US Patents and Regulatory Information for COLY-MYCIN M
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| >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 COLY-MYCIN M
| 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 |
