LOTEMAX SM Drug Patent 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 are three patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in LOTEMAX SM is loteprednol etabonate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lotemax Sm
A generic version of LOTEMAX SM was approved as loteprednol etabonate by SENTISS on April 17th, 2019.
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Summary for LOTEMAX SM
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 22 |
| Drug Prices: | Drug price information for LOTEMAX SM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LOTEMAX SM |
| What excipients (inactive ingredients) are in LOTEMAX SM? | LOTEMAX SM excipients list |
| DailyMed Link: | LOTEMAX SM at DailyMed |
Recent Clinical Trials for LOTEMAX SM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Thomas Chester, OD | Phase 4 |
| Illinois College of Optometry | Early Phase 1 |
| Dr Salouti Eye Research Center | Phase 4 |
Pharmacology for LOTEMAX SM
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for LOTEMAX SM
| 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 LOTEMAX SM
LOTEMAX SM is protected by three US patents.
| 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 | AB | 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 | AB | 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 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ 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
See the table below for patents covering LOTEMAX SM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2016211745 | ⤷ Start Trial | |
| Australia | 2021203027 | ⤷ Start Trial | |
| Australia | 2023248145 | ⤷ Start Trial | |
| Australia | 2025271194 | ⤷ Start Trial | |
| Brazil | 112017016016 | ⤷ Start Trial | |
| Canada | 2975106 | ⤷ Start Trial | |
| China | 107427464 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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