Orange Book product · Brand (NDA)
INVELTYS
LOTEPREDNOL ETABONATE
At a glance
Aug 22, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 22, 2018
7 yr 11 mo ago
Today
Patent 10058511 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Patent 10646437 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Patent 10688045 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Patent 10864219 expires
Listed method-of-use patent (U-3011) expiration.
May 03, 2033
in 7 yr
Patent 11219597 expires
Listed method-of-use patent (U-3278) expiration.
May 03, 2033
in 7 yr
Patent 11219597 expires
Listed method-of-use patent (U-3279) expiration.
May 03, 2033
in 7 yr
Patent 11642317 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Patent 11872318 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Patent 12115246 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Patent 9056057 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Patent 9393213 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Patent 9532955 expires
Listed method-of-use patent (U-2491) expiration.
May 03, 2033
in 7 yr
Patent 9737491 expires
Listed method-of-use patent (U-2492) expiration.
May 03, 2033
in 7 yr
Patent 9827191 expires
Listed drug product patent expiration.
May 03, 2033
in 7 yr
Pharmaceutical detail
Active ingredient
LOTEPREDNOL ETABONATE
Strength
1%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 210565
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.
- 2020EYSUVISBrand (NDA)
NDA 210933 · ALCON LABS INC
- 2019LOTEMAX SMBrand (NDA)
NDA 208219 · BAUSCH AND LOMB INC
- 2012LOTEMAXBrand (NDA)
NDA 202872 · BAUSCH AND LOMB INC
- 2011LOTEMAXBrand (NDA)
NDA 200738 · BAUSCH AND LOMB
- 1998ALREXBrand (NDA)
NDA 020803 · BAUSCH AND LOMB
- 1998LOTEMAXBrand (NDA)
NDA 020583 · BAUSCH AND LOMB
- 1998LOTEMAXBrand (NDA)
NDA 020841 · PHARMOS
- 2025LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 218087 · LUPIN
- 2025LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 217484 · AMNEAL
- 2025LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 215204 · PADAGIS US
- 2024LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 216345 · AMNEAL
- 2024LOTEPREDNOL ETABONATEGeneric (ANDA)
ANDA 215203 · PADAGIS US
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10058511 | May 03, 2033 | in 7 yr | ProductU-2492 |
| 10646437 | May 03, 2033 | in 7 yr | Product |
| 10688045 | May 03, 2033 | in 7 yr | Product |
| 10864219 | May 03, 2033 | in 7 yr | U-3011 |
| 11219597 | May 03, 2033 | in 7 yr | U-3278 |
| 11219597 | May 03, 2033 | in 7 yr | U-3279 |
| 11642317 | May 03, 2033 | in 7 yr | Product |
| 11872318 | May 03, 2033 | in 7 yr | Product |
| 12115246 | May 03, 2033 | in 7 yr | ProductU-4025 |
| 9056057 | May 03, 2033 | in 7 yr | ProductU-2491 |
| 9393213 | May 03, 2033 | in 7 yr | Product |
| 9532955 | May 03, 2033 | in 7 yr | U-2491 |
| 9737491 | May 03, 2033 | in 7 yr | U-2492 |
| 9827191 | May 03, 2033 | in 7 yr | ProductU-2493 |
