FDA Orange Book
Generic for Orfadin
Orfadin contains nitisinone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Orfadin is nitisinone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Orfadin products the Orange Book lists.
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Orfadin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Marketed (Rx) | AB | 3 | AB |
| capsule, oral | 20MG | Marketed (Rx) | AB | 2 | AB |
| capsule, oral | 2MG | Marketed (Rx) | AB | 3 | AB |
| capsule, oral | 5MG | Marketed (Rx) | AB | 3 | AB |
| suspension, oral | 4MG/ML | Marketed (Rx) | None | 0 | None |
NDA 021232, 206356, held by SWEDISH ORPHAN BIOVITRUM AB PUBL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nitisinone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 211041 | AB (A-rated, therapeutically equivalent) | August 26, 2019 | 10MG, 2MG, 5MG |
| MEDUNIK CANADA INC | 212390 | AB (A-rated, therapeutically equivalent) | May 26, 2022 | 10MG, 20MG, 2MG, 5MG |
| ETON PHARMACEUTICALS INC | 216201 | AB (A-rated, therapeutically equivalent) | May 25, 2023 | 10MG, 20MG, 2MG, 5MG |
Orfadin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9301932 | February 28, 2033 | Drug product | U-1836 | 206356 |
Orfadin NDC codes
Questions
Is there a generic for Orfadin?
Yes. The generic name for Orfadin is nitisinone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Orfadin products the Orange Book lists.
What is the generic name for Orfadin?
The active ingredient in Orfadin is nitisinone, per the FDA Orange Book.
When does the Orfadin patent expire?
The last patent listed for Orfadin in the Orange Book expires February 28, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.