FDA Orange Book · active-ingredient family
Lomustine
Lomustine is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GLEOSTINE · NDA 017588
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
3
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GLEOSTINERLD×4 | AZURITY | NDA 017588 | — | Dec 19, 2014 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOMUSTINE×3 | CARNEGIE | ANDA 219265 | AB | Oct 27, 2025 |
Marketing exclusivity (3)
- CGTFDA marketing exclusivity
May 19, 2026
1 mo ago
- CGTFDA marketing exclusivity
May 19, 2026
1 mo ago
- CGTFDA marketing exclusivity
May 19, 2026
1 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Lomustine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
