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

Eohilia products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension, oral2MG/10MLMarketed (Rx)None0None

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

Patents listed for Eohilia
PatentExpiresCoversUse codeNDA
9119863November 9, 2026Method of useU-3820213976
8975243November 9, 2026Method of useU-3820213976
8497258November 9, 2026Method of useU-3820213976
11197822November 9, 2026Drug productNone213976
11413296November 9, 2026Drug productNone213976
8679545November 9, 2026Drug productNone213976
11357859November 12, 2028Method of useU-3820213976
10293052November 22, 2028Drug productNone213976
9050368August 1, 2029Drug productNone213976
8324192August 3, 2029Method of useU-3820213976
11564934January 10, 2039Method of useU-3820213976
11260064January 10, 2039Drug productNone213976

Eohilia exclusivity

Exclusivity listed for Eohilia
CodeMeaningExpiresNDA
NPNew productFebruary 9, 2027213976
ODE-466Orphan drug exclusivityFebruary 9, 2031213976

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.

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