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 is one patent protecting this drug and one Paragraph IV challenge.
This drug has twenty-three patent family members in thirteen countries.
The generic ingredient in LOTEMAX SM is loteprednol etabonate. There are ten drug master file entries for this compound. Five 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 AKORN on April 17th, 2019.
Summary for LOTEMAX SM
| International Patents: | 23 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 22 |
| 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 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for LOTEMAX SM
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 one US patents and one FDA Regulatory Exclusivity.
Patents protecting LOTEMAX SM
Ophthalmic suspension composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF POST-OPERATIVE INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY
FDA Regulatory Exclusivity protecting LOTEMAX SM
NEW STRENGTH
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bausch And Lomb Inc | LOTEMAX SM | loteprednol etabonate | GEL;OPHTHALMIC | 208219-001 | Feb 22, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
|---|---|---|---|
| Spain | 2924645 | ⤷ Try a Trial | |
| Brazil | 112017016016 | composição de suspensão oftálmica | ⤷ Try a Trial |
| Poland | 3721868 | ⤷ Try a Trial | |
| Poland | 3470059 | ⤷ Try a Trial | |
| Australia | 2016211745 | Ophthalmic suspension composition | ⤷ Try a Trial |
| Portugal | 3721868 | ⤷ Try a Trial | |
| South Korea | 20170105610 | 안과용 현탁액 조성물 | ⤷ Try a 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. 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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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