Orange Book product · Brand (NDA)
DEXTENZA
DEXAMETHASONE
At a glance
Nov 30, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 2018
7 yr 8 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Apr 07, 2028
in 1 yr 10 mo
Patent 8563027 expires
Listed method-of-use patent (U-2487) expiration.
Feb 12, 2030
in 3 yr 8 mo
Patent 8409606 expires
Listed drug product patent expiration.
May 14, 2030
in 4 yr
Patent 12150896 expires
Listed method-of-use patent (U-1680) expiration.
Oct 07, 2036
in 10 yr 5 mo
Patent 12150896 expires
Listed method-of-use patent (U-3455) expiration.
Oct 07, 2036
in 10 yr 5 mo
Patent 11458041 expires
Listed method-of-use patent (U-1680) expiration.
Nov 16, 2037
in 11 yr 7 mo
Patent 11458041 expires
Listed method-of-use patent (U-3455) expiration.
Nov 16, 2037
in 11 yr 7 mo
Patent 12144889 expires
Listed method-of-use patent (U-1680) expiration.
Apr 26, 2041
in 15 yr 1 mo
Pharmaceutical detail
Active ingredient
DEXAMETHASONE
Strength
0.4MG
Dosage form
INSERT
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 208742
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.
- 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
- 2023DEXAMETHASONEGeneric (ANDA)
ANDA 217696 · NOVITIUM PHARMA
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
Apr 07, 2028
in 1 yr 10 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8563027 | Feb 12, 2030 | in 3 yr 8 mo | U-2487 |
| 8409606 | May 14, 2030 | in 4 yr | Product |
| 12150896 | Oct 07, 2036 | in 10 yr 5 mo | U-1680 |
| 12150896 | Oct 07, 2036 | in 10 yr 5 mo | U-3455 |
| 11458041 | Nov 16, 2037 | in 11 yr 7 mo | U-1680 |
| 11458041 | Nov 16, 2037 | in 11 yr 7 mo | U-3455 |
| 12144889 | Apr 26, 2041 | in 15 yr 1 mo | U-1680 |
