FDA Orange Book
Generic for Ferriprox
Ferriprox contains deferiprone. 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 Ferriprox is deferiprone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Ferriprox products the Orange Book lists.
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Ferriprox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 100MG/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | 80MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 1GM | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 1GM | Marketed (Rx) | None | 3 | AB |
| tablet, oral | 500MG | Discontinued | None | 3 | AB |
NDA 208030, 021825, 212269, held by CHIESI USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic deferiprone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 213239 | AB (A-rated, therapeutically equivalent) | February 8, 2022 | 1GM, 1GM, 500MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 208800 | AB (A-rated, therapeutically equivalent) | November 22, 2023 | 1GM, 1GM, 500MG |
| PHARMAZONE | 220132 | AB (A-rated, therapeutically equivalent) | December 11, 2025 | 1GM, 1GM, 500MG |
Ferriprox patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8703156 | October 26, 2029 | Drug product | U-3083 | 208030 |
| 11723874 | October 25, 2038 | Method of use | U-3083 | 212269 |
| 11357731 | October 25, 2038 | Method of use | U-3083 | 212269 |
| 10940115 | October 25, 2038 | Drug product | U-3083 | 212269 |
| 10780055 | October 25, 2038 | Drug product | U-3083 | 212269 |
| 11458103 | October 25, 2038 | Drug product | None | 212269 |
| 10940116 | October 25, 2038 | Drug product | None | 212269 |
Ferriprox exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-417 | Orphan drug exclusivity | April 30, 2028 | 208030 |
| ODE-418 | Orphan drug exclusivity | April 30, 2028 | 208030 |
| ODE-419 | Orphan drug exclusivity | April 30, 2028 | 208030 |
| ODE-420 | Orphan drug exclusivity | April 30, 2028 | 021825 |
| ODE-421 | Orphan drug exclusivity | April 30, 2028 | 021825 |
Ferriprox NDC codes
Questions
Is there a generic for Ferriprox?
Yes. The generic name for Ferriprox is deferiprone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Ferriprox products the Orange Book lists.
What is the generic name for Ferriprox?
The active ingredient in Ferriprox is deferiprone, per the FDA Orange Book.
When does the Ferriprox patent expire?
The last patent listed for Ferriprox in the Orange Book expires October 25, 2038. 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.