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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 215092


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NDA 215092 describes OMLONTI, which is a drug marketed by Visiox Pharma and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the OMLONTI profile page.

The generic ingredient in OMLONTI is omidenepag isopropyl. One supplier is listed for this compound. Additional details are available on the omidenepag isopropyl profile page.
Summary for 215092
Tradename:OMLONTI
Applicant:Visiox Pharma
Ingredient:omidenepag isopropyl
Patents:11
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215092
Generic Entry Date for 215092*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SOLUTION;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: 215092
Suppliers and Packaging for NDA: 215092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMLONTI omidenepag isopropyl SOLUTION;OPHTHALMIC 215092 NDA Santen Incorporated 65086-002 65086-002-01 1 BOTTLE, PLASTIC in 1 CARTON (65086-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC
OMLONTI omidenepag isopropyl SOLUTION;OPHTHALMIC 215092 NDA Santen Incorporated 65086-002 65086-002-05 1 BOTTLE, PLASTIC in 1 CARTON (65086-002-05) / 2.5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;OPHTHALMICStrength0.002%
Approval Date:Sep 22, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 22, 2027
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Jan 8, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS
Patent:⤷  Sign UpPatent Expiration:Jan 8, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS

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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.