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.
Run it in Rivvi
Map Hemady and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Hemady products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 20MG | Marketed (Rx) | None | 0 | None |
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
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11304961 | December 18, 2037 | Drug product | U-3344 | 211379 |
| 10537585 | December 18, 2037 | Drug product | None | 211379 |
Hemady exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-271 | Orphan drug exclusivity | October 3, 2026 | 211379 |
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.
More on Hemady and Dexamethasone
- What is Dexamethasone used for?FDA label uses
- Is Dexamethasone a controlled substance?Federal schedule
- Generic for DecadronFDA Orange Book
- Generic for HexadrolFDA Orange Book
- Generic for OzurdexFDA Orange Book
- Generic for DextenzaFDA Orange Book
- Generic for MaxidexFDA Orange Book
- Corticosteroids listFDA drug class
- NDC 82111-955Hemady NDC record