Drug
Who makes nitisinone?
6 companies list nitisinone as a human prescription drug, including under the names HARLIKU, NITYR, Orfadin. Forms: capsule; suspension; tablet. 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 nitisinone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Swedish Orphan Biovitrum AB (publ) | capsule; suspension | NDANDA021232, NDA206356 | 5 | 0 |
| Analog Pharma | capsule | ANDAANDA212390 | 4 | 0 |
| Cycle Pharmaceuticals Ltd-Uk | tablet | NDANDA209449 | 4 | 0 |
| Eton Pharmaceuticals, Inc. | capsule | ANDAANDA216201 | 4 | 0 |
| Par Health USA, LLCIndia | capsule | ANDAANDA211041 | 3 | 5 |
| Bryant Ranch PrepackUnited States | capsule | ANDAANDA211041 | 3 | 1 |
Bulk ingredient listings
- Amino Chemicals Ltd.Malta · 1 NDC
- Anthem Biosciences LimitedIndia · 1 NDC
- Bachem AGSwitzerland · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- SCL Lifesciences LimitedIndia · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
Orange Book patents
2 unexpired patents list nitisinone as the active ingredient, expiring between Feb 2033 and Jan 2035. Application holders: CYCLE PHARMACEUTICALS LTD, SWEDISH ORPHAN BIOVITRUM AB PUBL.
Enquiry
Common questions
- Who makes nitisinone?
- 6 companies list nitisinone as a human prescription drug in the openFDA NDC Directory, led by Swedish Orphan Biovitrum AB (publ), Analog Pharma, Cycle Pharmaceuticals Ltd-Uk, Eton Pharmaceuticals, Inc., Par Health USA, LLC. 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 HARLIKU?
- 4 companies list nitisinone under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies nitisinone active ingredient?
- 7 companies list nitisinone as a bulk ingredient, including Amino Chemicals Ltd., Anthem Biosciences Limited, Bachem AG, Cohance Lifesciences Limited.