Miebo is a drug owned by Bausch And Lomb Inc. It is protected by 6 US drug patents filed in 2023 out of which none have expired yet. Miebo's patents will be open to challenges from 19 May, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 21, 2037. Details of Miebo'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). | |||
| US10507132 | Topical administration method |
Jun, 2037
(12 years from now) | Active |
| US11357738 | Semifluorinated compounds and their compositions |
Sep, 2036
(11 years from now) | Active |
| US10576154 | Semifluorinated alkane compositions |
Sep, 2033
(8 years from now) | Active |
| US10449164 | Methods of treating ocular disorders using semifluorinated alkanes |
Sep, 2033
(8 years from now) | Active |
| US10369117 | Compositions comprising mixtures of semifluorinated alkanes |
Sep, 2033
(8 years from now) | Active |
| US10058615 | Semifluorinated alkane compositions |
Sep, 2033
(8 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 Miebo's patents.
Latest Legal Activities on Miebo's Patents
Given below is the list of recent legal activities going on the following patents of Miebo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US10576154 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US10369117 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US11357738 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US10449164 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US10058615 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US10369117 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US11357738 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US10576154 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US10058615 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US10449164 |
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 Miebo and ongoing litigations to help you estimate the early arrival of Miebo generic.
Miebo's Litigations
Miebo been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 17, 2018, against patent number US10449164. The petitioner , challenged the validity of this patent, with Novaliq GmbH as the respondent. Click below to track the latest information on how companies are challenging Miebo's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10449164 | April, 2018 |
Decision
(17 Jan, 2019) | Novaliq GmbH | |
FDA has granted some exclusivities to Miebo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Miebo, 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 Miebo.
Exclusivity Information
Miebo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Miebo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 18, 2028 |
US patents provide insights into the exclusivity only within the United States, but Miebo 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 Miebo's family patents as well as insights into ongoing legal events on those patents.
Miebo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Miebo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 21, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Miebo Generics:
There are no approved generic versions for Miebo as of now.
Alternative Brands for Miebo
Miebo which is used for managing dry eye disease symptoms., has several other brand drugs in the same treatment category . 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.
About Miebo
Miebo is a drug owned by Bausch And Lomb Inc. It is used for managing dry eye disease symptoms. Miebo uses Perfluorohexyloctane as an active ingredient. Miebo was launched by Bausch And Lomb Inc in 2023.
Approval Date:
Miebo was approved by FDA for market use on 18 May, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Miebo is 18 May, 2023, its NCE-1 date is estimated to be 19 May, 2027.
Active Ingredient:
Miebo uses Perfluorohexyloctane as the active ingredient. Check out other Drugs and Companies using Perfluorohexyloctane ingredient
Treatment:
Miebo is used for managing dry eye disease symptoms.
Dosage:
Miebo is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.338GM/ML | SOLUTION/DROPS | Prescription | OPHTHALMIC |