simvastatin · Synthon Pharms · NDA 021961
Simvastatin
Earliest generic entry, as listed · earliest of 4 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021961 · 001 · RLD · discontinued | tablet, orally disintegrating, oral | 10MG | open |
| 021961 · 002 · RLD · discontinued | tablet, orally disintegrating, oral | 20MG | open |
| 021961 · 003 · RLD · discontinued | tablet, orally disintegrating, oral | 40MG | open |
| 021961 · 004 · RLD · discontinued | tablet, orally disintegrating, oral | 80MG | open |