Lotemax Sm is a drug owned by Bausch And Lomb Inc. It is protected by 2 US drug patents filed from 2020 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 23, 2036. Details of Lotemax Sm's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10596107 | Ophthalmic suspension composition |
Dec, 2036
(11 years from now) | Active |
| US11534395 | Ophthalmic suspension composition |
Jan, 2036
(10 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Lotemax Sm's patents.
Latest Legal Activities on Lotemax Sm's Patents
Given below is the list of recent legal activities going on the following patents of Lotemax Sm.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Aug, 2023 | US10596107 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Dec, 2022 | US11534395 |
| Recordation of Patent Grant Mailed Critical | 27 Dec, 2022 | US11534395 |
| Email Notification Critical | 08 Dec, 2022 | US11534395 |
| Issue Notification Mailed Critical | 07 Dec, 2022 | US11534395 |
| Dispatch to FDC | 22 Nov, 2022 | US11534395 |
| Application Is Considered Ready for Issue Critical | 22 Nov, 2022 | US11534395 |
| Issue Fee Payment Verified Critical | 18 Nov, 2022 | US11534395 |
| Issue Fee Payment Received Critical | 18 Nov, 2022 | US11534395 |
| Electronic Review Critical | 22 Aug, 2022 | US11534395 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Lotemax Sm and ongoing litigations to help you estimate the early arrival of Lotemax Sm generic.
Lotemax Sm's Litigations
Lotemax Sm been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 22, 2019, against patent number US10596107. The petitioner , challenged the validity of this patent, with Mohannad Shawer et al. as the respondent. Click below to track the latest information on how companies are challenging Lotemax Sm's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10596107 | January, 2019 |
Decision
(18 Jul, 2019) | Mohannad Shawer et al. | |
FDA has granted some exclusivities to Lotemax Sm. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lotemax Sm, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Lotemax Sm.
Exclusivity Information
Lotemax Sm holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Lotemax Sm's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | Feb 22, 2022 |
Several oppositions have been filed on Lotemax Sm's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Lotemax Sm's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lotemax Sm patents.
Lotemax Sm's Oppositions Filed in EPO
Lotemax Sm has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 04, 2019, by Allergan, Inc.. This opposition was filed on patent number EP16704744A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP20166312A | Feb, 2023 | SANDOZ AG | Granted and Under Opposition |
| EP18209003A | Dec, 2020 | Sandoz AG | Granted and Under Opposition |
| EP16704744A | Sep, 2019 | Breuer, Markus | Revoked |
| EP16704744A | Sep, 2019 | European Oppositions Limited | Revoked |
| EP16704744A | Sep, 2019 | ALLERGAN, INC. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Lotemax Sm is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Lotemax Sm's family patents as well as insights into ongoing legal events on those patents.
Lotemax Sm's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lotemax Sm's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 23, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lotemax Sm Generic API suppliers:
Loteprednol Etabonate is the generic name for the brand Lotemax Sm. 6 different companies have already filed for the generic of Lotemax Sm, with Sentiss having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lotemax Sm's generic
How can I launch a generic of Lotemax Sm before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lotemax Sm's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lotemax Sm's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Lotemax Sm -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0038 | 14 Nov, 2022 | 1 | 23 Dec, 2036 |
Alternative Brands for Lotemax Sm
Lotemax Sm which is used for reducing inflammation and pain after ocular surgery., has several other brand drugs using the same active ingredient (Loteprednol Etabonate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| Alcon Labs Inc |
| |||
| Bausch And Lomb |
| |||
| Bausch And Lomb Inc |
| |||
| Pharmos |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Loteprednol Etabonate, Lotemax Sm's active ingredient. Check the complete list of approved generic manufacturers for Lotemax Sm
About Lotemax Sm
Lotemax Sm is a drug owned by Bausch And Lomb Inc. It is used for reducing inflammation and pain after ocular surgery. Lotemax Sm uses Loteprednol Etabonate as an active ingredient. Lotemax Sm was launched by Bausch And Lomb Inc in 2019.
Approval Date:
Lotemax Sm was approved by FDA for market use on 22 February, 2019.
Active Ingredient:
Lotemax Sm uses Loteprednol Etabonate as the active ingredient. Check out other Drugs and Companies using Loteprednol Etabonate ingredient
Treatment:
Lotemax Sm is used for reducing inflammation and pain after ocular surgery.
Dosage:
Lotemax Sm is available in gel form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.38% | GEL | Prescription | OPHTHALMIC |