FDA Orange Book
Generic for Emflaza
Emflaza contains deflazacort. 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 Emflaza is deflazacort. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Emflaza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 22.75MG/ML | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 18MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 30MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 36MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 6MG | Marketed (Rx) | AB | 6 | AB |
NDA 208685, 208684, held by PTC THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic deflazacort
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 217123 | AB (A-rated, therapeutically equivalent) | February 9, 2024 | 18MG, 30MG, 36MG, 6MG |
| TRIS PHARMA INC | 217813 | AB (A-rated, therapeutically equivalent) | April 25, 2024 | 22.75MG/ML |
| UPSHER SMITH LABORATORIES LLC | 216720 | AB (A-rated, therapeutically equivalent) | November 5, 2024 | 18MG, 30MG, 36MG, 6MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 217741 | AB (A-rated, therapeutically equivalent) | March 18, 2025 | 18MG, 30MG, 36MG, 6MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 219254 | AB (A-rated, therapeutically equivalent) | April 8, 2025 | 18MG, 30MG, 36MG, 6MG |
| AUCTA PHARMACEUTICALS INC | 219417 | AB (A-rated, therapeutically equivalent) | June 30, 2025 | 22.75MG/ML |
| UPSHER SMITH LABORATORIES LLC | 216992 | AB (A-rated, therapeutically equivalent) | August 11, 2025 | 22.75MG/ML |
| ZYDUS LIFESCIENCES GLOBAL FZE | 220042 | AB (A-rated, therapeutically equivalent) | October 3, 2025 | 22.75MG/ML |
| AMNEAL EU LTD | 217173 | AB (A-rated, therapeutically equivalent) | December 12, 2025 | 18MG, 30MG, 36MG, 6MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 219930 | AB (A-rated, therapeutically equivalent) | January 27, 2026 | 22.75MG/ML |
| BIOCON PHARMA INC | 220709 | AB (A-rated, therapeutically equivalent) | May 28, 2026 | 22.75MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 220524 | AB (A-rated, therapeutically equivalent) | September 18, 2026 | 18MG, 30MG, 36MG, 6MG |
Emflaza exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-252 | Orphan drug exclusivity | June 7, 2026 | 208685 |
Emflaza NDC codes
Questions
Is there a generic for Emflaza?
Yes. The generic name for Emflaza is deflazacort. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Emflaza?
The active ingredient in Emflaza is deflazacort, per the FDA Orange Book.
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.