SMOFLIPID 20% Drug Patent Profile
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Which patents cover Smoflipid 20%, and what generic alternatives are available?
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 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 19 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | SMOFLIPID 20% at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SMOFLIPID 20%
Generic Entry Date for SMOFLIPID 20%*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION 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 |
|---|---|
| Assiut University | N/A |
| Assiut University | Phase 3 |
| Giulia Manzini | Phase 3 |
Pharmacology for SMOFLIPID 20%
| Drug Class | Lipid Emulsion |
Anatomical Therapeutic Chemical (ATC) Classes for SMOFLIPID 20%
US Patents and Regulatory Information for SMOFLIPID 20%
SMOFLIPID 20% is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SMOFLIPID 20% is ⤷ Try a Trial.
This potential generic entry date is based on NEW PATIENT POPULATION.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting SMOFLIPID 20%
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
