FDA Orange Book · active-ingredient family
Cladribine
Cladribine is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MAVENCLAD · NDA 022561
2
Brand (NDA)
6
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MAVENCLADRLD | EMD SERONO INC | NDA 022561 | AB | Mar 29, 2019 | |
| LEUSTATINRLD | JANSSEN PHARMS | NDA 020229 | — | Feb 26, 1993 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLADRIBINE | HOPEWELL PHARMA | ANDA 215547 | AB | Mar 27, 2026 | |
| CLADRIBINE | APOTEX | ANDA 218425 | AB | Nov 24, 2025 | |
| CLADRIBINE | HISUN PHARM HANGZHOU | ANDA 210856 | AP | Nov 25, 2019 | |
| CLADRIBINE | PHARMOBEDIENT | ANDA 200510 | — | Oct 06, 2011 | |
| CLADRIBINE | FRESENIUS KABI USA | ANDA 076571 | AP | Apr 22, 2004 | |
| CLADRIBINE | HIKMA | ANDA 075405 | AP | Feb 28, 2000 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10849919 | Nov 23, 2038 | in 12 yr 7 mo | U-3411 |
| 12533408 | Sep 10, 2041 | in 15 yr 5 mo | U-4395 |
| 12539329 | Sep 10, 2041 | in 15 yr 5 mo | U-4399 |
Cladribine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
