FDA Orange Book · active-ingredient family
Cladribine
Cladribine: 2 brands, 6 generics; first approved Feb 26, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
6
Listed patents
3
Next patent expiry
Nov 23, 2038
in 12 yr 5 mo
Brand (NDA) products
Originator applications
Generic (ANDA) products (6)
Abbreviated applications
- CLADRIBINEHOPEWELL PHARMAANDA 2155472026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - CLADRIBINEAPOTEXANDA 2184252025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - CLADRIBINEHISUN PHARM HANGZHOUANDA 2108562019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CLADRIBINEPHARMOBEDIENTANDA 2005102011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - CLADRIBINERSFRESENIUS KABI USAANDA 0765712004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - CLADRIBINEHIKMAANDA 0754052000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10849919 | in 12 yr 5 mo | U-3411 | |
| 12533408 | in 15 yr 3 mo | U-4395 | |
| 12539329 | in 15 yr 3 mo | U-4399 |
Approval history
FDA approval span
First approval
34 yr ago
Most recent approval
5 mo ago
Approvals span 1993–2026 across 8 FDA applications.
Brand (NDA) 225%
Generic (ANDA) 675%
Cladribine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
