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 Par Sterile Products 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. Six 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 XGEN PHARMS on February 26th, 1999.
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: | 9 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Sterile Products | COLY-MYCIN M | colistimethate sodium | INJECTABLE;INJECTION | 050108-002 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ 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 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 |
