FDA Orange Book
Is there a generic for Eohilia?
Eohilia contains budesonide. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Eohilia (budesonide). The Orange Book shows its last listed patent expires January 10, 2039 and its last listed exclusivity ends February 9, 2031.
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Eohilia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 2MG/10ML | Marketed (Rx) | None | 0 | None |
NDA 213976, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Eohilia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9119863 | November 9, 2026 | Method of use | U-3820 | 213976 |
| 8975243 | November 9, 2026 | Method of use | U-3820 | 213976 |
| 8497258 | November 9, 2026 | Method of use | U-3820 | 213976 |
| 11197822 | November 9, 2026 | Drug product | None | 213976 |
| 11413296 | November 9, 2026 | Drug product | None | 213976 |
| 8679545 | November 9, 2026 | Drug product | None | 213976 |
| 11357859 | November 12, 2028 | Method of use | U-3820 | 213976 |
| 10293052 | November 22, 2028 | Drug product | None | 213976 |
| 9050368 | August 1, 2029 | Drug product | None | 213976 |
| 8324192 | August 3, 2029 | Method of use | U-3820 | 213976 |
| 11564934 | January 10, 2039 | Method of use | U-3820 | 213976 |
| 11260064 | January 10, 2039 | Drug product | None | 213976 |
Eohilia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | February 9, 2027 | 213976 |
| ODE-466 | Orphan drug exclusivity | February 9, 2031 | 213976 |
Eohilia NDC codes
Questions
Is there a generic for Eohilia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Eohilia (budesonide). The Orange Book shows its last listed patent expires January 10, 2039 and its last listed exclusivity ends February 9, 2031.
What is the generic name for Eohilia?
The active ingredient in Eohilia is budesonide, per the FDA Orange Book.
When does the Eohilia patent expire?
The last patent listed for Eohilia in the Orange Book expires January 10, 2039. 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.
More on Eohilia and Budesonide
- What is Budesonide used for?FDA label uses
- Is Budesonide a controlled substance?Federal schedule
- Generic for UcerisFDA Orange Book
- Generic for Entocort ECFDA Orange Book
- Generic for TarpeyoFDA Orange Book
- Generic for Pulmicort FlexhalerFDA Orange Book
- Generic for Pulmicort RespulesFDA Orange Book
- Corticosteroids listFDA drug class
- NDC 64764-105Eohilia NDC record