Drug
Who makes cladribine?
7 companies list cladribine as a human prescription drug, including under the names Mavenclad. Forms: injection; injection, solution; tablet. Routes: intravenous, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing cladribine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| EMD Serono, Inc.France | tablet | NDANDA022561 | 1 | 12 |
| Apotex Inc.Canada | tablet | ANDAANDA218425 | 1 | 6 |
| Fresenius Kabi USA, LLCUnited States | injection | ANDAANDA076571 | 1 | 6 |
| Sandoz Industrial Products S.AAustria | tablet | ANDAANDA215547 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA075405 | 1 | 4 |
| Genvion CorporationCanada | tablet | ANDAANDA218425 | 1 | 1 |
| Hisun Pharmaceuticals USA, Inc. | injection, solution | ANDAANDA210856 | 1 | 0 |
Bulk ingredient listings
- Cilag AG · 2 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 2 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Reliable Biopharmaceutical, LLCUnited States · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Zhejiang Hisun Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
3 unexpired patents list cladribine as the active ingredient, expiring between Nov 2038 and Sept 2041. Application holder: EMD SERONO INC.
Enquiry
Common questions
- Who makes cladribine?
- 7 companies list cladribine as a human prescription drug in the openFDA NDC Directory, led by EMD Serono, Inc., Apotex Inc., Fresenius Kabi USA, LLC, Sandoz Industrial Products S.A, Hikma Pharmaceuticals USA Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Mavenclad?
- 6 companies list cladribine under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies cladribine active ingredient?
- 6 companies list cladribine as a bulk ingredient, including Cilag AG, Sionc Pharmaceuticals Private Limited, MSN Laboratories Private Limited,, Reliable Biopharmaceutical, LLC.