doravirine; islatravir · Msd · NDA 216964
Idvynso
Earliest generic entry, as listed
30 Aug 2032
Blocked by patent: US 8486975.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8486975 | substance, product, use U-4527 | 30 Aug 2032 |
| US 7339053 | substance | 31 May 2027 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 20 Apr 2031 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216964 · 001 · RLD | tablet, oral | 100MG;0.25MG | 30 Aug 2032 |