FDA Orange Book

Is there a generic for Hemady?

Hemady contains dexamethasone. 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 Hemady (dexamethasone). The Orange Book shows its last listed patent expires December 18, 2037 and its last listed exclusivity ends October 3, 2026.

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Hemady products in the Orange Book

Hemady products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral20MGMarketed (Rx)None0None

NDA 211379, held by DEXCEL PHARMA TECHNOLOGIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Hemady patents

Patents listed for Hemady
PatentExpiresCoversUse codeNDA
11304961December 18, 2037Drug productU-3344211379
10537585December 18, 2037Drug productNone211379

Hemady exclusivity

Exclusivity listed for Hemady
CodeMeaningExpiresNDA
ODE-271Orphan drug exclusivityOctober 3, 2026211379

Hemady NDC codes

Questions

Is there a generic for Hemady?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Hemady (dexamethasone). The Orange Book shows its last listed patent expires December 18, 2037 and its last listed exclusivity ends October 3, 2026.

What is the generic name for Hemady?

The active ingredient in Hemady is dexamethasone, per the FDA Orange Book.

When does the Hemady patent expire?

The last patent listed for Hemady in the Orange Book expires December 18, 2037. 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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