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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the perfluorohexyloctane profile page.
The generic ingredient in MIEBO is perfluorohexyloctane. There is one drug master file entry for this compound. 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.
Pharmacology for NDA: 216675
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: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 1.338GM/ML | ||||
| Approval Date: | May 18, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 18, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,058,615 | Patent Expiration: | Sep 12, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | ||||||||
| Patent: | 10,369,117 | Patent Expiration: | Sep 12, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | ||||||||
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