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SMOFLIPID 20% Drug Profile
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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%
Generic Entry Date for SMOFLIPID 20%*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
Dosage:
EMULSION;INTRAVENOUS |
*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.
Recent Clinical Trials for SMOFLIPID 20%
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fresenius Kabi | Phase 4 |
| Fresenius Kabi | Phase 1/Phase 2 |
| Mayo Clinic | Phase 4 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | SMOFLIPID 20% | fish oil; medium chain triglycerides; olive oil; soybean oil | EMULSION;INTRAVENOUS | 207648-004 | Aug 10, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | SMOFLIPID 20% | fish oil; medium chain triglycerides; olive oil; soybean oil | EMULSION;INTRAVENOUS | 207648-002 | Jul 13, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
