FDA Orange Book · active-ingredient family
Loteprednol etabonate
Loteprednol etabonate is approved as 8 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EYSUVIS · NDA 210933
8
Brand (NDA)
13
Generics (ANDA)
23
Listed patents
0
Exclusivity periods
Brand (NDA) products · gel, ointment, suspension/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EYSUVISRLD | ALCON LABS INC | NDA 210933 | — | Oct 26, 2020 | |
| LOTEMAX SMRLD | BAUSCH AND LOMB INC | NDA 208219 | AB | Feb 22, 2019 | |
| INVELTYSRLD | ALCON LABS INC | NDA 210565 | — | Aug 22, 2018 | |
| LOTEMAXRLD | BAUSCH AND LOMB INC | NDA 202872 | AB | Sep 28, 2012 | |
| LOTEMAXRLD | BAUSCH AND LOMB | NDA 200738 | — | Apr 15, 2011 | |
| ALREXRLD | BAUSCH AND LOMB | NDA 020803 | AB | Mar 09, 1998 | |
| LOTEMAXRLD | BAUSCH AND LOMB | NDA 020583 | AB | Mar 09, 1998 | |
| LOTEMAX | PHARMOS | NDA 020841 | — | Mar 09, 1998 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOTEPREDNOL ETABONATE | LUPIN | ANDA 218087 | AB | Jun 30, 2025 | |
| LOTEPREDNOL ETABONATE | AMNEAL | ANDA 217484 | AB | May 20, 2025 | |
| LOTEPREDNOL ETABONATE | PADAGIS US | ANDA 215204 | AB | Jan 29, 2025 | |
| LOTEPREDNOL ETABONATE | AMNEAL | ANDA 216345 | AB | Dec 13, 2024 | |
| LOTEPREDNOL ETABONATE | PADAGIS US | ANDA 215203 | AB | Jul 10, 2024 | |
| LOTEPREDNOL ETABONATE | LUPIN | ANDA 215719 | AB | Apr 24, 2024 | |
| LOTEPREDNOL ETABONATE | LUPIN | ANDA 215550 | AB | Dec 26, 2023 | |
| LOTEPREDNOL ETABONATE | HIKMA | ANDA 213956 | — | Nov 29, 2023 | |
| LOTEPREDNOL ETABONATE | SUN PHARM | ANDA 215384 | AB | Aug 09, 2023 | |
| LOTEPREDNOL ETABONATE | SENTISS | ANDA 215933 | AB | Apr 12, 2023 | |
| LOTEPREDNOL ETABONATE | SUN PHARM | ANDA 212450 | AB | Feb 26, 2021 | |
| LOTEPREDNOL ETABONATE | SENTISS | ANDA 212080 | AB | Feb 10, 2021 | |
| LOTEPREDNOL ETABONATE | SENTISS | ANDA 207609 | AB | Apr 17, 2019 |
Listed patents (23)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11219596 | May 03, 2033 | in 7 yr | U-2985 |
| 11596599 | May 03, 2033 | in 7 yr | U-2985 |
| 10857096 | May 03, 2033 | in 7 yr | U-2985 |
| 10945948 | May 03, 2033 | in 7 yr | U-2985 |
| 10940108 | May 03, 2033 | in 7 yr | U-2985 |
| 9532955 | May 03, 2033 | in 7 yr | U-2491 |
| 9737491 | May 03, 2033 | in 7 yr | U-2492 |
| 9056057 | May 03, 2033 | in 7 yr | ProductU-2491 |
| 9827191 | May 03, 2033 | in 7 yr | ProductU-2985 |
| 10058511 | May 03, 2033 | in 7 yr | ProductU-2492 |
| 10993908 | May 03, 2033 | in 7 yr | U-3117 |
| 12115246 | May 03, 2033 | in 7 yr | ProductU-2985 |
| 11642317 | May 03, 2033 | in 7 yr | Product |
| 10688045 | May 03, 2033 | in 7 yr | Product |
| 10646436 | May 03, 2033 | in 7 yr | Product |
| 9393213 | May 03, 2033 | in 7 yr | Product |
| 11872318 | May 03, 2033 | in 7 yr | Product |
| 11219597 | May 03, 2033 | in 7 yr | U-3278 |
| 10864219 | May 03, 2033 | in 7 yr | U-3011 |
| 10646437 | May 03, 2033 | in 7 yr | Product |
| 11534395 | Jan 26, 2036 | in 9 yr 9 mo | ProductU-2764 |
| 12589069 | Jan 26, 2036 | in 9 yr 9 mo | ProductU-2764 |
| 10596107 | Dec 23, 2036 | in 10 yr 8 mo | ProductU-2764 |
Loteprednol etabonate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
