sirolimus · Pf Prism Cv · NDA 021083, 021110
Rapamune
Earliest generic entry, as listed · earliest of 4 marketed strengths
Open now
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021083 · 001 · RLD | solution, oral | 1MG/ML | open |
| 021110 · 001 · RLD | tablet, oral | 1MG | open |
| 021110 · 002 · RLD | tablet, oral | 2MG | open |
| 021110 · 003 · RLD · discontinued | tablet, oral | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021110 · 004 · RLD | tablet, oral | 0.5MG | open |