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LOTEMAX SM Drug Profile
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When do Lotemax Sm patents expire, and what generic alternatives are available?
Lotemax Sm is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There is one patent protecting this drug.
This drug has thirteen patent family members in twelve countries.
The generic ingredient in LOTEMAX SM is loteprednol etabonate. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
US ANDA Litigation and Generic Entry Outlook for Lotemax Sm
A generic version of LOTEMAX SM was approved as loteprednol etabonate by HI TECH on April 17th, 2019.
Summary for LOTEMAX SM
| International Patents: | 13 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 20 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LOTEMAX SM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LOTEMAX SM |
| DailyMed Link: | LOTEMAX SM at DailyMed |
Recent Clinical Trials for LOTEMAX SM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr Salouti Eye Research Center | Phase 4 |
| Shiraz University of Medical Sciences | Phase 4 |
| Tel-Aviv Sourasky Medical Center | N/A |
Pharmacology for LOTEMAX SM
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for LOTEMAX SM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch And Lomb Inc | LOTEMAX SM | loteprednol etabonate | GEL;OPHTHALMIC | 208219-001 | Feb 22, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bausch And Lomb Inc | LOTEMAX SM | loteprednol etabonate | GEL;OPHTHALMIC | 208219-001 | Feb 22, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for LOTEMAX SM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3250185 | Start Trial |
| Australia | 2016211745 | Start Trial |
| European Patent Office | 3470059 | Start Trial |
| China | 107427464 | Start Trial |
| Poland | 3250185 | Start Trial |
| Canada | 2975106 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
