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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 216675


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NDA 216675 describes MIEBO, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the MIEBO profile page.

The generic ingredient in MIEBO is perfluorohexyloctane. One supplier is listed for this compound. Additional details are available on the perfluorohexyloctane profile page.
Summary for 216675
Tradename:MIEBO
Applicant:Bausch And Lomb Inc
Ingredient:perfluorohexyloctane
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216675
Generic Entry Date for 216675*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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.

Suppliers and Packaging for NDA: 216675
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIEBO perfluorohexyloctane SOLUTION/DROPS;OPHTHALMIC 216675 NDA Bausch & Lomb Incorporated 24208-377 24208-377-01 1 BOTTLE in 1 CARTON (24208-377-01) / 3 mg in 1 BOTTLE
MIEBO perfluorohexyloctane SOLUTION/DROPS;OPHTHALMIC 216675 NDA Bausch & Lomb Incorporated 24208-377 24208-377-05 1 BOTTLE in 1 CARTON (24208-377-05) / 3 mg in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1.338GM/ML
Approval Date:May 18, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:May 18, 2028
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Sep 12, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
Patent:⤷  Sign UpPatent Expiration:Sep 12, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

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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.