MIEBO Drug Patent Profile
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When do Miebo patents expire, and what generic alternatives are available?
Miebo is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and three patent family members in sixteen countries.
The generic ingredient in MIEBO is perfluorohexyloctane. One supplier is listed for this compound. Additional details are available on the perfluorohexyloctane profile page.
DrugPatentWatch® Generic Entry Outlook for Miebo
Miebo will be eligible for patent challenges on May 18, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 18, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for MIEBO
| International Patents: | 103 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for MIEBO |
| What excipients (inactive ingredients) are in MIEBO? | MIEBO excipients list |
| DailyMed Link: | MIEBO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MIEBO
Generic Entry Date for MIEBO*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
Dosage:
SOLUTION/DROPS;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
US Patents and Regulatory Information for MIEBO
MIEBO is protected by six US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MIEBO is ⤷ Try a Trial.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting MIEBO
Semifluorinated alkane compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Compositions comprising mixtures of semifluorinated alkanes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Methods of treating ocular disorders using semifluorinated alkanes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Topical administration method
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Semifluorinated alkane compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Semifluorinated compounds and their compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting MIEBO
NEW CHEMICAL ENTITY
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 | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | 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 MIEBO
When does loss-of-exclusivity occur for MIEBO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 13314303
Estimated Expiration: ⤷ Try a Trial
Patent: 13314370
Estimated Expiration: ⤷ Try a Trial
Patent: 16219611
Estimated Expiration: ⤷ Try a Trial
Patent: 17200907
Estimated Expiration: ⤷ Try a Trial
Patent: 18201364
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015004997
Estimated Expiration: ⤷ Try a Trial
Patent: 2015005008
Estimated Expiration: ⤷ Try a Trial
Patent: 2019024319
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 83002
Estimated Expiration: ⤷ Try a Trial
Patent: 83003
Estimated Expiration: ⤷ Try a Trial
Patent: 97744
Estimated Expiration: ⤷ Try a Trial
Patent: 42049
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4619314
Estimated Expiration: ⤷ Try a Trial
Patent: 4755073
Estimated Expiration: ⤷ Try a Trial
Patent: 6511322
Estimated Expiration: ⤷ Try a Trial
Patent: 3679697
Estimated Expiration: ⤷ Try a Trial
Patent: 3679698
Estimated Expiration: ⤷ Try a Trial
Patent: 3679699
Estimated Expiration: ⤷ Try a Trial
Patent: 3694048
Estimated Expiration: ⤷ Try a Trial
Patent: 3952321
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 95144
Estimated Expiration: ⤷ Try a Trial
Patent: 81119
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 95144
Estimated Expiration: ⤷ Try a Trial
Patent: 95158
Estimated Expiration: ⤷ Try a Trial
Patent: 00722
Estimated Expiration: ⤷ Try a Trial
Patent: 81119
Estimated Expiration: ⤷ Try a Trial
Patent: 88847
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2013012742
Estimated Expiration: ⤷ Try a Trial
Patent: 2013012753
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 10041
Estimated Expiration: ⤷ Try a Trial
Patent: 10052
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 39152
Estimated Expiration: ⤷ Try a Trial
Patent: 53717
Estimated Expiration: ⤷ Try a Trial
Patent: 52266
Estimated Expiration: ⤷ Try a Trial
Patent: 52366
Estimated Expiration: ⤷ Try a Trial
Patent: 40893
Estimated Expiration: ⤷ Try a Trial
Patent: 40919
Estimated Expiration: ⤷ Try a Trial
Patent: 15527386
Estimated Expiration: ⤷ Try a Trial
Patent: 15531344
Estimated Expiration: ⤷ Try a Trial
Patent: 16193931
Estimated Expiration: ⤷ Try a Trial
Patent: 17048228
Estimated Expiration: ⤷ Try a Trial
Patent: 18111704
Estimated Expiration: ⤷ Try a Trial
Patent: 18150377
Estimated Expiration: ⤷ Try a Trial
Patent: 19001818
Estimated Expiration: ⤷ Try a Trial
Patent: 20073535
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 5124
Estimated Expiration: ⤷ Try a Trial
Patent: 6228
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 0588
Estimated Expiration: ⤷ Try a Trial
Patent: 0469
Estimated Expiration: ⤷ Try a Trial
Patent: 3182
Estimated Expiration: ⤷ Try a Trial
Patent: 15003228
Estimated Expiration: ⤷ Try a Trial
Patent: 15003229
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 95144
Estimated Expiration: ⤷ Try a Trial
Patent: 81119
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 95144
Estimated Expiration: ⤷ Try a Trial
Patent: 81119
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1874219
Estimated Expiration: ⤷ Try a Trial
Patent: 2115111
Estimated Expiration: ⤷ Try a Trial
Patent: 2158400
Estimated Expiration: ⤷ Try a Trial
Patent: 2171897
Estimated Expiration: ⤷ Try a Trial
Patent: 150054996
Estimated Expiration: ⤷ Try a Trial
Patent: 150054997
Estimated Expiration: ⤷ Try a Trial
Patent: 160104747
Estimated Expiration: ⤷ Try a Trial
Patent: 180101640
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 21226
Estimated Expiration: ⤷ Try a Trial
Patent: 45084
Estimated Expiration: ⤷ Try a Trial
Patent: 70398
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering MIEBO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2017055454 | ⤷ Try a Trial | |
| Australia | 2013314370 | Compositions comprising mixtures of semifluorinated alkanes | ⤷ Try a Trial |
| Australia | 2016219611 | Compositions comprising mixtures of semifluorinated alkanes | ⤷ Try a Trial |
| European Patent Office | 3488847 | COMPOSITIONS D'ALCANE SEMIFLUORÉ (SEMIFLUORINATED ALKANE COMPOSITIONS) | ⤷ Try a Trial |
| Brazil | 122019024319 | USO DE COMPOSIÇÕES DE ALCANO SEMIFLUORADO NA FABRICAÇÃO DE UM MEDICAMENTO PARA O TRATAMENTO DE UMA CONDIÇÃO ASSOCIADA COM QUERATOCONJUNTIVITE SECA | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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