FDA Orange Book
Is there a generic for Prevymis?
Prevymis contains letermovir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Prevymis (letermovir). The Orange Book shows its last listed patent expires February 28, 2033 and its last listed exclusivity ends August 30, 2031.
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Prevymis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| pellets, oral | 120MG/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | 20MG/PACKET | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 240MG/12ML (20MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 480MG/24ML (20MG/ML) | Marketed (Rx) | None | 0 | None |
| tablet, oral | 240MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 480MG | Marketed (Rx) | None | 0 | None |
NDA 219104, 209940, 209939, held by MERCK SHARP AND DOHME LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Prevymis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE46791 | January 18, 2029 | Drug substance, Drug product | None | 219104 |
| 10603384 | February 28, 2033 | Drug product | None | 209940 |
Prevymis exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-916 | New indication | June 5, 2026 | 209940 |
| D-189 | New dosing schedule | August 2, 2026 | 209940 |
| NP | New product | August 30, 2027 | 219104 |
| NPP | New patient population | August 30, 2027 | 209940 |
| ODE* | See the Orange Book exclusivity code list | June 5, 2030 | 219104 |
| ODE-423 | Orphan drug exclusivity | June 5, 2030 | 209940 |
| ODE-495 | Orphan drug exclusivity | August 30, 2031 | 219104 |
| ODE-497 | Orphan drug exclusivity | August 30, 2031 | 219104 |
Prevymis NDC codes
Questions
Is there a generic for Prevymis?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Prevymis (letermovir). The Orange Book shows its last listed patent expires February 28, 2033 and its last listed exclusivity ends August 30, 2031.
What is the generic name for Prevymis?
The active ingredient in Prevymis is letermovir, per the FDA Orange Book.
When does the Prevymis patent expire?
The last patent listed for Prevymis in the Orange Book expires February 28, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.