letermovir · Merck Sharp Dohme · NDA 209939, 209940, 219104
Prevymis
Earliest generic entry, as listed · earliest of 6 marketed strengths
30 Aug 2031
Other strengths are listed to 28 Feb 2033.
Blocked by exclusivity: ODE-497, ODE-495.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10603384 | product | 28 Feb 2033 |
| US RE46791 | substance, product | 18 Jan 2029 |
Exclusivities · 6 unexpired
| ODE-497 | orphan drug (7 years) | 30 Aug 2031 |
| ODE-495 | orphan drug (7 years) | 30 Aug 2031 |
| ODE-423 | orphan drug (7 years) | 5 Jun 2030 |
| ODE* | 5 Jun 2030 | |
| NP | new product | 30 Aug 2027 |
| NPP | new patient population | 30 Aug 2027 |
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209939 · 001 · RLD | tablet, oral | 240MG | 30 Aug 2031 |
| 209939 · 002 · RLD | tablet, oral | 480MG | 30 Aug 2031 |
| 209940 · 001 · RLD | solution, intravenous | 240MG/12ML (20MG/ML) | 28 Feb 2033 |
| 209940 · 002 · RLD | solution, intravenous | 480MG/24ML (20MG/ML) | 28 Feb 2033 |
| 219104 · 001 · RLD | pellets, oral | 20MG/PACKET | 30 Aug 2031 |
| 219104 · 002 · RLD | pellets, oral | 120MG/PACKET | 30 Aug 2031 |
Expired or delisted (2)
- D-189 · 2 Aug 2026
- I-916 · 5 Jun 2026