Drug
Who makes loteprednol etabonate?
11 companies list loteprednol etabonate as a human prescription drug, including under the names Alrex, Eysuvis, Inveltys, Lotemax, Lotemax SM. Forms: gel; ointment; suspension; suspension/ drops. Routes: ophthalmic, topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing loteprednol etabonate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bausch & Lomb Ireland LimitedUnited States | gel; ointment; suspension/ drops | NDA, NDA AUTHORIZED GENERICNDA020583, NDA020803, NDA200738 | 6 | 4 |
| Alcon Laboratories, IncUnited States | suspension; suspension/ drops | NDANDA210565, NDA210933 | 3 | 3 |
| SENTISS PHARMA PRIVATE LIMITEDIndia | gel; suspension/ drops | ANDAANDA207609, ANDA212080, ANDA215933 | 3 | 2 |
| Amneal Pharmaceuticals NY LLC | suspension/ drops | ANDAANDA216345, ANDA217484 | 3 | 0 |
| Armas Pharmaceuticals, Inc. | gel; suspension/ drops | ANDAANDA207609, ANDA212080, ANDA215933 | 3 | 0 |
| Bausch & Lomb Americas Inc. | gel; suspension/ drops | NDA AUTHORIZED GENERICNDA020583, NDA020803, NDA202872 | 3 | 0 |
| Padagis Israel Pharmaceuticals LtdUnited States | suspension/ drops | ANDAANDA215203, ANDA215204 | 2 | 2 |
| Lupin LimitedIndia | suspension | ANDAANDA215719 | 1 | 14 |
| Sun Pharmaceutical Industries LimitedIndia | suspension/ drops | ANDAANDA212450 | 1 | 13 |
| NorthStar RxLLC | suspension/ drops | ANDAANDA212450 | 1 | 0 |
| Sportpharm LLC | suspension/ drops | ANDAANDA215933 | 1 | 0 |
Bulk ingredient listings
- Farmabios S.p.A.Italy · 2 NDC
- Industriale Chimica SRLItaly · 2 NDC
- AARTI PHARMALABS LIMITEDIndia · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- ZACH SYSTEM S.A.France · 1 NDC
Orange Book patents
23 unexpired patents list loteprednol etabonate as the active ingredient, expiring between May 2033 and Dec 2036. Application holders: ALCON LABORATORIES INC, BAUSCH AND LOMB INC.
Enquiry
Common questions
- Who makes loteprednol etabonate?
- 11 companies list loteprednol etabonate as a human prescription drug in the openFDA NDC Directory, led by Bausch & Lomb Ireland Limited, Alcon Laboratories, Inc, SENTISS PHARMA PRIVATE LIMITED, Amneal Pharmaceuticals NY LLC, Armas Pharmaceuticals, Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Alrex?
- 8 companies list loteprednol etabonate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies loteprednol etabonate active ingredient?
- 6 companies list loteprednol etabonate as a bulk ingredient, including Farmabios S.p.A., Industriale Chimica SRL, AARTI PHARMALABS LIMITED, Curia India Private Limited.