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 seven 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
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Summary for MIEBO
| International Patents: | 107 |
| 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
*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 ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Compositions comprising mixtures of semifluorinated alkanes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Methods of treating ocular disorders using semifluorinated alkanes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Topical administration method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Semifluorinated alkane compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Semifluorinated compounds and their compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting MIEBO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb Inc | MIEBO | perfluorohexyloctane | SOLUTION/DROPS;OPHTHALMIC | 216675-001 | May 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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
Patent: Semifluorinated alkane compositions
Estimated Expiration: ⤷ Sign Up
Patent: 13314370
Patent: Compositions comprising mixtures of semifluorinated alkanes
Estimated Expiration: ⤷ Sign Up
Patent: 16219611
Patent: Compositions comprising mixtures of semifluorinated alkanes
Estimated Expiration: ⤷ Sign Up
Patent: 17200907
Patent: SEMIFLUORINATED ALKANE COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
Patent: 18201364
Patent: COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015004997
Patent: composições contendo misturas de alcanos semifluorados
Estimated Expiration: ⤷ Sign Up
Patent: 2015005008
Patent: composições de alcano semifluorado
Estimated Expiration: ⤷ Sign Up
Patent: 2019024319
Patent: USO DE COMPOSIÇÕES DE ALCANO SEMIFLUORADO NA FABRICAÇÃO DE UM MEDICAMENTO PARA O TRATAMENTO DE UMA CONDIÇÃO ASSOCIADA COM QUERATOCONJUNTIVITE SECA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 83002
Patent: COMPOSITIONS COMPRENANT DES MELANGES D'ALCANES SEMI-FLUORES (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 83003
Patent: COMPOSITIONS D'ALCANES SEMIFLUORES (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 97744
Patent: COMPOSITIONS COMPRENANT DES MELANGES D'ALCANES SEMI-FLUORES (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 42049
Patent: COMPOSITIONS D'ALCANES SEMIFLUORES (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 4619314
Patent: Compositions comprising mixtures of semifluorinated alkanes
Estimated Expiration: ⤷ Sign Up
Patent: 4755073
Patent: Semifluorinated alkane compositions
Estimated Expiration: ⤷ Sign Up
Patent: 6511322
Patent: 包含半氟化烷烃的混合物的组合物 (Compositions comprising mixtures of semifluorinated alkanes)
Estimated Expiration: ⤷ Sign Up
Patent: 3679697
Patent: 包含半氟化烷烃的混合物的组合物 (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 3679698
Patent: 包含半氟化烷烃的混合物的组合物 (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 3679699
Patent: 包含半氟化烷烃的混合物的组合物 (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 3694048
Patent: 包含半氟化烷烃的混合物的组合物 (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 3952321
Patent: 包含半氟化烷烃的混合物的组合物 (Compositions comprising mixtures of semifluorinated alkanes)
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 95144
Estimated Expiration: ⤷ Sign Up
Patent: 81119
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 95144
Patent: COMPOSITIONS D'ALCANE SEMIFLUORÉ (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 95158
Patent: COMPOSITIONS COMPRENANT DES MÉLANGES D'ALCANES SEMI-FLUORÉS (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 00722
Patent: D'ALCANES SEMI-FLUORÉS POUR SOLUBILISER DE MEIBUM (SEMIFLUORINATED ALKANES FOR USE IN SOLUBILIZING MEIBUM)
Estimated Expiration: ⤷ Sign Up
Patent: 81119
Patent: COMPOSITIONS D'ALKANE SEMIFLUORÉ POUR UTILISATION DANS LE TRAITEMENT DE LA SECHERESSE OCULAIRE (SEMIFLUORINATED ALKANE COMPOSITIONS FOR USE IN THE TREATMENT OF KERATOCONJUNCTIVITIS SICCA)
Estimated Expiration: ⤷ Sign Up
Patent: 88847
Patent: COMPOSITIONS D'ALCANE SEMIFLUORÉ (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 42537
Patent: COMPOSITIONS D'ALCANE SEMIFLUORÉ (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2013012742
Estimated Expiration: ⤷ Sign Up
Patent: 2013012753
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 10041
Patent: 包含半氟化烷烴的混合物的組合物 (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 10052
Patent: 半氟化烷烴組合物 (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 39152
Estimated Expiration: ⤷ Sign Up
Patent: 53717
Estimated Expiration: ⤷ Sign Up
Patent: 52266
Estimated Expiration: ⤷ Sign Up
Patent: 52366
Estimated Expiration: ⤷ Sign Up
Patent: 40893
Estimated Expiration: ⤷ Sign Up
Patent: 40919
Estimated Expiration: ⤷ Sign Up
Patent: 15527386
Patent: 半フッ素化アルカン組成物
Estimated Expiration: ⤷ Sign Up
Patent: 15531344
Patent: 半フッ化アルカンの混合物を含む組成物
Estimated Expiration: ⤷ Sign Up
Patent: 16193931
Patent: 半フッ化アルカンの混合物を含む組成物 (COMPOSITIONS CONTAINING SEMIFLUORINATED ALKANE MIXTURES)
Estimated Expiration: ⤷ Sign Up
Patent: 17048228
Patent: 半フッ素化アルカン組成物 (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 18111704
Patent: 半フッ化アルカンの混合物を含む組成物 (COMPOSITION CONTAINING MIXTURE OF SEMI-FLUORIDATED ALKANE)
Estimated Expiration: ⤷ Sign Up
Patent: 18150377
Patent: 半フッ素化アルカン組成物 (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 19001818
Patent: 半フッ素化アルカン組成物 (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 20073535
Patent: 半フッ素化アルカン組成物 (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 5124
Patent: SEMIFLUORINATED ALKANE COMPOSITIONS
Estimated Expiration: ⤷ Sign Up
Patent: 6228
Patent: COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 0588
Patent: COMPOSICIONES DE ALCANOS SEMIFLUORADOS. (SEMIFLUORINATED ALKANE COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
Patent: 0469
Patent: COMPOSICIONES QUE COMPRENDEN MEZCLAS DE ALCANOS SEMIFLUORADOS. (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES.)
Estimated Expiration: ⤷ Sign Up
Patent: 3182
Patent: COMPOSICIONES QUE COMPRENDEN MEZCLAS DE ALCANOS SEMIFLUORADOS. (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES.)
Estimated Expiration: ⤷ Sign Up
Patent: 15003228
Patent: COMPOSICIONES DE ALCANOS SEMIFLUORADOS. (SEMIFLUORINATED ALKANE COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up
Patent: 15003229
Patent: COMPOSICIONES QUE COMPRENDEN MEZCLAS DE ALCANOS SEMIFLUORADOS. (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES.)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 95144
Estimated Expiration: ⤷ Sign Up
Patent: 81119
Estimated Expiration: ⤷ Sign Up
Patent: 88847
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 95144
Estimated Expiration: ⤷ Sign Up
Patent: 81119
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1874219
Estimated Expiration: ⤷ Sign Up
Patent: 2115111
Estimated Expiration: ⤷ Sign Up
Patent: 2158400
Estimated Expiration: ⤷ Sign Up
Patent: 2171897
Estimated Expiration: ⤷ Sign Up
Patent: 150054996
Patent: 부분불소화 알칸의 혼합물을 포함하는 조성물 (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 150054997
Patent: 부분불소화 알칸 조성물 (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 160104747
Patent: 부분불소화 알칸의 혼합물을 포함하는 조성물 (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES)
Estimated Expiration: ⤷ Sign Up
Patent: 180101640
Patent: 부분불소화 알칸 조성물 (SEMIFLUORINATED ALKANE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 21226
Estimated Expiration: ⤷ Sign Up
Patent: 45084
Estimated Expiration: ⤷ Sign Up
Patent: 70398
Estimated Expiration: ⤷ Sign Up
Patent: 65828
Estimated Expiration: ⤷ Sign Up
Patent: 74663
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Denmark | 3355990 | ⤷ Sign Up | |
| China | 108348777 | 半氟化化合物和其组合物 (SEMIFLUORINATED COMPOUNDS AND THEIR COMPOSITIONS) | ⤷ Sign Up |
| Poland | 3355990 | ⤷ Sign Up | |
| European Patent Office | 4342537 | COMPOSITIONS D'ALCANE SEMIFLUORÉ (SEMIFLUORINATED ALKANE COMPOSITIONS) | ⤷ Sign Up |
| South Korea | 20150054996 | 부분불소화 알칸의 혼합물을 포함하는 조성물 (COMPOSITIONS COMPRISING MIXTURES OF SEMIFLUORINATED ALKANES) | ⤷ Sign Up |
| Spain | 2770398 | ⤷ Sign Up | |
| >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.
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