DrugPatentWatch Database Preview
SMOFLIPID 20% Drug Profile
When do Smoflipid 20% patents expire, and when can generic versions of Smoflipid 20% launch?
Smoflipid 20% is a drug marketed by Fresenius Kabi Usa and is included in one NDA.
The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fish oil; medium chain triglycerides; olive oil; soybean oil profile page.
Summary for SMOFLIPID 20%
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 14 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | SMOFLIPID 20% at DailyMed |
Generic Entry Opportunity Date for SMOFLIPID 20%
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for SMOFLIPID 20%
| Drug Class | Lipid Emulsion |
US Patents and Regulatory Information for SMOFLIPID 20%
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | SMOFLIPID 20% | fish oil; medium chain triglycerides; olive oil; soybean oil | EMULSION;INTRAVENOUS | 207648-001 | Jul 13, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Fresenius Kabi Usa | SMOFLIPID 20% | fish oil; medium chain triglycerides; olive oil; soybean oil | EMULSION;INTRAVENOUS | 207648-004 | Aug 10, 2018 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Fresenius Kabi Usa | SMOFLIPID 20% | fish oil; medium chain triglycerides; olive oil; soybean oil | EMULSION;INTRAVENOUS | 207648-002 | Jul 13, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Fresenius Kabi Usa | SMOFLIPID 20% | fish oil; medium chain triglycerides; olive oil; soybean oil | EMULSION;INTRAVENOUS | 207648-003 | Jul 13, 2016 | 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 |
