simvastatin · Salerno Pharms · NDA 206679
Flolipid
Earliest generic entry, as listed · earliest of 2 marketed strengths
23 Feb 2030
Blocked by patent: US 9597289.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9597289 | drug product · sets the listed date | 23 Feb 2030 |
| US 10300041 | drug product | 26 Apr 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206679 · 001 · RLD | suspension, oral | 20MG/5ML | 23 Feb 2030 |
| 206679 · 002 · RLD | suspension, oral | 40MG/5ML | 23 Feb 2030 |