OMLONTI Drug Patent Profile

Which patents cover Omlonti, and what generic alternatives are available?

Omlonti is a drug marketed by Visiox Pharma and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and twenty-nine patent family members in thirty-two countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Omlonti

Omlonti will be eligible for patent challenges on September 22, 2026. 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 September 22, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OMLONTI

International Patents:	129
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	27
What excipients (inactive ingredients) are in OMLONTI?	OMLONTI excipients list
DailyMed Link:	OMLONTI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OMLONTI

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215092

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 OMLONTI

Drug Class	Prostaglandin E2 Receptor Agonist
Mechanism of Action	Prostaglandin E2 Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for OMLONTI

S01EX	Other antiglaucoma preparations
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for OMLONTI

OMLONTI is protected by eleven US patents and one FDA Regulatory Exclusivity.

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 OMLONTI

FDA Regulatory Exclusivity protecting OMLONTI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No			Y
Visiox Pharma	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092-001	Sep 22, 2022		DISCN	Yes	No			Y

International Patents for OMLONTI

See the table below for patents covering OMLONTI around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2264009
Australia	2010231630	Pharmaceutical composition for treating or preventing glaucoma
Turkey	201902019