Orange Book product · Brand (NDA)
BYQLOVI
CLOBETASOL PROPIONATE
At a glance
Mar 04, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 04, 2024
2 yr 4 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Mar 04, 2027
in 9 mo
Patent 10588913 expires
Listed drug product patent expiration.
May 09, 2036
in 10 yr
Patent 11376262 expires
Listed drug product patent expiration.
May 09, 2036
in 10 yr
Pharmaceutical detail
Active ingredient
CLOBETASOL PROPIONATE
Strength
0.05%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 218158
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.
- 2020IMPEKLOBrand (NDA)
NDA 213691 · PHARMOBEDIENT
- 2017IMPOYZBrand (NDA)
NDA 209483 · PRIMUS PHARMS
- 2007OLUX EBrand (NDA)
NDA 022013 · PHARMOBEDIENT
- 2003CLOBEXBrand (NDA)
NDA 021535 · GALDERMA LABS LP
- 2000OLUXBrand (NDA)
NDA 021142 · PHARMOBEDIENT
- 1994TEMOVATE EBrand (NDA)
NDA 020340 · FOUGERA PHARMS
- 1994TEMOVATEBrand (NDA)
NDA 020337 · FOUGERA PHARMS
- 1985TEMOVATEBrand (NDA)
NDA 019322 · FOUGERA PHARMS
- 2025CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 210638 · XIROMED
- 2024CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 208563 · TARO
- 2022CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 215838 · ALEMBIC
- 2021CLOBETASOL PROPIONATEGeneric (ANDA)
ANDA 211207 · CHARTWELL RX
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Mar 04, 2027
in 9 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10588913 | May 09, 2036 | in 10 yr | Product |
| 11376262 | May 09, 2036 | in 10 yr | ProductU-19 |
