LOTEPREDNOL ETABONATE Drug Patent Profile
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Which patents cover Loteprednol Etabonate, and when can generic versions of Loteprednol Etabonate launch?
Loteprednol Etabonate is a drug marketed by Hikma, Sentiss, Sun Pharm, Lupin Ltd, and Padagis Us. and is included in nine NDAs.
The generic ingredient in LOTEPREDNOL ETABONATE is loteprednol etabonate. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Loteprednol Etabonate
A generic version of LOTEPREDNOL ETABONATE was approved as loteprednol etabonate by SENTISS on April 17th, 2019.
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Summary for LOTEPREDNOL ETABONATE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 47 |
| Patent Applications: | 4,390 |
| Drug Prices: | Drug price information for LOTEPREDNOL ETABONATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LOTEPREDNOL ETABONATE |
| What excipients (inactive ingredients) are in LOTEPREDNOL ETABONATE? | LOTEPREDNOL ETABONATE excipients list |
| DailyMed Link: | LOTEPREDNOL ETABONATE at DailyMed |
Recent Clinical Trials for LOTEPREDNOL ETABONATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kala Pharmaceuticals, Inc. | Phase 4 |
| Price Vision Group | Phase 4 |
| Thomas Chester, OD | Phase 4 |
Pharmacology for LOTEPREDNOL ETABONATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for LOTEPREDNOL ETABONATE
Anatomical Therapeutic Chemical (ATC) Classes for LOTEPREDNOL ETABONATE
Paragraph IV (Patent) Challenges for LOTEPREDNOL ETABONATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LOTEMAX SM | Ophthalmic Gel | loteprednol etabonate | 0.38% | 208219 | 1 | 2022-11-14 |
US Patents and Regulatory Information for LOTEPREDNOL ETABONATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | LOTEPREDNOL ETABONATE | loteprednol etabonate | GEL;OPHTHALMIC | 213956-001 | Nov 29, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sentiss | LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 215933-001 | Apr 12, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 215550-001 | Dec 26, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sentiss | LOTEPREDNOL ETABONATE | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 207609-001 | Apr 17, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sentiss | LOTEPREDNOL ETABONATE | loteprednol etabonate | GEL;OPHTHALMIC | 212080-001 | Feb 10, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | LOTEPREDNOL ETABONATE | loteprednol etabonate | GEL;OPHTHALMIC | 215384-001 | Aug 9, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
