Loteprednol Etabonate Patent Expiration
Loteprednol Etabonate is Used for treating steroid-responsive conditions in the eye, such as inflammation of the conjunctiva, cornea, and anterior segment. It was first introduced by Bausch And Lomb Inc
Loteprednol Etabonate Patents
Given below is the list of patents protecting Loteprednol Etabonate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Lotemax Sm | US10596107 | Ophthalmic suspension composition | Dec 23, 2036 | Bausch And Lomb Inc |
| Lotemax Sm | US11534395 | Ophthalmic suspension composition | Jan 26, 2036 | Bausch And Lomb Inc |
| Eysuvis | US10058511 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US10646436 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US10688045 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US10857096 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US10940108 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US10945948 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US10993908 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US11219596 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US11596599 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US11642317 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US11872318 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US12115246 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US9056057 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US9393213 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US9532955 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US9737491 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Eysuvis | US9827191 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US10058511 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US10646437 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US10688045 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US10864219 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US11219597 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US11642317 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US11872318 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US12115246 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US9056057 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US9393213 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US9532955 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US9737491 | Nanocrystals, compositions, and methods that aid particle transport in mucus | May 03, 2033 | Alcon Labs Inc |
| Inveltys | US9827191 | Compositions and methods for ophthalmic and/or other applications | May 03, 2033 | Alcon Labs Inc |
| Lotemax | US5800807 | Ophthalmic compositions including glycerin and propylene glycol |
Jan 29, 2017
(Expired) | Bausch And Lomb Inc |
| Alrex |
US5540930 (Pediatric) | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Apr 25, 2014
(Expired) | Bausch And Lomb |
| Alrex |
US5747061 (Pediatric) | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Apr 25, 2014
(Expired) | Bausch And Lomb |
| Lotemax |
US5540930 (Pediatric) | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Apr 25, 2014
(Expired) | Bausch And Lomb |
| Lotemax |
US5747061 (Pediatric) | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Apr 25, 2014
(Expired) | Bausch And Lomb |
| Alrex | US5540930 | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Oct 25, 2013
(Expired) | Bausch And Lomb |
| Alrex | US5747061 | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Oct 25, 2013
(Expired) | Bausch And Lomb |
| Lotemax | US5540930 | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Oct 25, 2013
(Expired) | Bausch And Lomb |
| Lotemax | US5540930 | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Oct 25, 2013
(Expired) | Pharmos |
| Lotemax | US5747061 | Suspension of loteprednol etabonate for ear, eye, or nose treatment |
Oct 25, 2013
(Expired) | Bausch And Lomb |
| Alrex |
US4996335 (Pediatric) | Soft steroids having anti-inflammatory activity |
Sep 09, 2012
(Expired) | Bausch And Lomb |
| Lotemax |
US4996335 (Pediatric) | Soft steroids having anti-inflammatory activity |
Sep 09, 2012
(Expired) | Bausch And Lomb |
Loteprednol Etabonate's Family Patents
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Loteprednol Etabonate Generic API Manufacturers
Several generic applications have been filed for Loteprednol Etabonate. The first generic version for Loteprednol Etabonate was by Sentiss Ag and was approved on Apr 17, 2019. And the latest generic version is by Padagis Us Llc and was approved on Jan 29, 2025.
Given below is the list of companies who have filed for Loteprednol Etabonate generic, along with the locations of their manufacturing plants worldwide.
1. AMNEAL
Amneal Eu Ltd has filed for 1 generic for Loteprednol Etabonate. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.2% | suspension/drops | Prescription | OPHTHALMIC | AB | Dec 13, 2024 |
Manufacturing Plant Locations New
Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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2. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Loteprednol Etabonate. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5% | gel | Discontinued | OPHTHALMIC | N/A | Nov 29, 2023 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Portugal |
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| Jordan |
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3. LUPIN LTD
Lupin Ltd has filed for 2 different strengths of generic version for Loteprednol Etabonate. Given below are the details of the strengths of this generic introduced by Lupin Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.2% | suspension/drops | Prescription | OPHTHALMIC | AB | Dec 26, 2023 |
| 0.5% | suspension/drops | Prescription | OPHTHALMIC | AB | Apr 24, 2024 |
Manufacturing Plant Locations New
Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
4. PADAGIS US
Padagis Us Llc has filed for 2 different strengths of generic version for Loteprednol Etabonate. Given below are the details of the strengths of this generic introduced by Padagis Us.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.2% | suspension/drops | Prescription | OPHTHALMIC | AB | Jul 10, 2024 |
| 0.5% | suspension/drops | Prescription | OPHTHALMIC | AB | Jan 29, 2025 |
Manufacturing Plant Locations New
Padagis Us's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Padagis Us as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
5. SENTISS
Sentiss Ag has filed for 2 different strengths of generic version for Loteprednol Etabonate. Given below are the details of the strengths of this generic introduced by Sentiss.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5% | gel | Prescription | OPHTHALMIC | AB | Feb 10, 2021 |
| 0.2% | suspension/drops | Prescription | OPHTHALMIC | AB | Apr 12, 2023 |
Manufacturing Plant Locations New
Sentiss's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Sentiss as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
6. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Loteprednol Etabonate. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5% | gel | Prescription | OPHTHALMIC | AB | Aug 9, 2023 |
Manufacturing Plant Locations New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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