Drug
Who makes nilotinib?
12 companies list nilotinib as a human prescription drug, including under the names CAVHANZA, DANZITEN, Tasigna. Forms: capsule; tablet; tablet, orally disintegrating. Routes: 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 nilotinib
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Novartis Pharmaceuticals CorporationSwitzerland | capsule | NDANDA022068 | 3 | 20 |
| Dr. Reddy's Laboratories LimitedIndia | capsule | ANDAANDA218350 | 3 | 15 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | capsule | NDANDA218922 | 3 | 7 |
| Apotex Inc.Canada | capsule | ANDAANDA203640 | 3 | 6 |
| Exelan Pharmaceuticals, Inc. | capsule | NDANDA218922 | 3 | 0 |
| Novadoz Pharmaceuticals LLC | capsule | ANDAANDA218544 | 3 | 0 |
| Novartis Pharma Stein AG | capsule | DRUG FOR FURTHER PROCESSING | 3 | 0 |
| Torrent Pharma, Inc.India | capsule | ANDAANDA218532 | 2 | 5 |
| Camber Pharmaceuticals, Inc.United States | capsule | ANDAANDA209651 | 2 | 1 |
| AvKARE | capsule | ANDAANDA218544 | 2 | 0 |
| Azurity Pharmaceuticals, Inc. | tablet | NDANDA219293 | 2 | 0 |
| Cycle Pharmaceuticals Ltd-Uk | tablet, orally disintegrating | NDANDA217379 | 2 | 0 |
Bulk ingredient listings
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Viyash Scientific LimitedIndia · 1 NDC
Orange Book patents
4 unexpired patents list nilotinib as the active ingredient, expiring between Jan 2041 and Apr 2041. Application holder: CYCLE PHARMACEUTICALS LTD.
Enquiry
Common questions
- Who makes nilotinib?
- 12 companies list nilotinib as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Dr. Reddy's Laboratories Limited, CIPLA PHARMACEUTICALS LIMITED, Apotex Inc., Exelan Pharmaceuticals, 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 CAVHANZA?
- 6 companies list nilotinib under an abbreviated new drug application (ANDA), the application type used for generics, and 5 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies nilotinib active ingredient?
- 3 companies list nilotinib as a bulk ingredient, including Dr. Reddy's Laboratories Limited, MSN Laboratories Private Limited,, Viyash Scientific Limited.