Orange Book product · Brand (NDA)
HEMADY
DEXAMETHASONE
At a glance
Oct 03, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 03, 2019
6 yr 10 mo ago
Today
Exclusivity ends · ODE-271
Orphan-drug exclusivity (7 years)
Oct 03, 2026
in 4 mo
Patent 10537585 expires
Listed drug product patent expiration.
Dec 18, 2037
in 11 yr 8 mo
Patent 11304961 expires
Listed drug product patent expiration.
Dec 18, 2037
in 11 yr 8 mo
Pharmaceutical detail
Active ingredient
DEXAMETHASONE
Strength
20MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211379
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2018DEXTENZABrand (NDA)
NDA 208742 · OCULAR THERAPEUTIX
- 2018DEXYCU KITBrand (NDA)
NDA 208912 · EYEPOINT PHARMS
- 2009OZURDEXBrand (NDA)
NDA 022315 · ABBVIE
- —DECASPRAYBrand (NDA)
NDA 012731 · MERCK
- —DECADRONBrand (NDA)
NDA 012376 · MERCK
- —HEXADROLBrand (NDA)
NDA 012674 · ASPEN GLOBAL INC
- —DECADERMBrand (NDA)
NDA 013538 · MERCK
- —MAXIDEXBrand (NDA)
NDA 013422 · HARROW EYE
- —DECADRONBrand (NDA)
NDA 011664 · MERCK
- 2024DEXAMETHASONEGeneric (ANDA)
ANDA 218372 · COREPHARMA
- 2023DEXAMETHASONEGeneric (ANDA)
ANDA 215604 · NOVITIUM PHARMA
- 2023DEXAMETHASONEGeneric (ANDA)
ANDA 217695 · APOTEX
Marketing exclusivity (1)
- ODE-271Orphan-drug exclusivity (7 years)
Oct 03, 2026
in 4 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10537585 | Dec 18, 2037 | in 11 yr 8 mo | Product |
| 11304961 | Dec 18, 2037 | in 11 yr 8 mo | ProductU-3344 |
