Is there a generic for Omidenepag isopropyl?

The FDA Orange Book does not currently list an approved generic (ANDA) for Omidenepag isopropyl. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Omidenepag isopropyl?

OMLONTI (NDA 215092, OCUVEX THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Omidenepag isopropyl?

The Orange Book lists 13 patents against Omidenepag isopropyl products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Omidenepag isopropyl have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Omidenepag isopropyl. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Omidenepag isopropyl are approved?

Omidenepag isopropyl is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Omidenepag isopropyl

Omidenepag isopropyl: 1 brand, 0 generics; first approved Sep 22, 2022; on patent until Oct 13, 2029.

On patent1 exclusivity period

Generic status & protection

Protected until Oct 13, 2029 (earliest listed patent expiry).

Earliest patent expiry Oct 13, 2029Latest exclusivity ends Sep 22, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 13, 2029

in 3 yr 3 mo

Originator applications

Brand (NDA) products

OMLONTIRLDRS

OCUVEX THERAPNDA 2150922022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.002%	SOLUTION	OPHTHALMIC	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

NCENew chemical entity exclusivity (5 years)
Sep 22, 2027
in 1 yr 2 mo

Orange Book patent file

Listed patents

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8648097	Oct 13, 2029	in 3 yr 3 mo	SubstanceProduct
8685986	Oct 13, 2029	in 3 yr 3 mo	Product
12295946	Jan 08, 2035	in 8 yr 7 mo	ProductU-3454
11197849	Jan 08, 2035	in 8 yr 7 mo	ProductU-3454
10702511	Jan 08, 2035	in 8 yr 7 mo	ProductU-3454
10179127	Jan 08, 2035	in 8 yr 7 mo	ProductU-3454
9415038	Jan 08, 2035	in 8 yr 7 mo	ProductU-3454
RE48183	Jan 08, 2035	in 8 yr 7 mo	ProductU-3454
11793798	Jan 08, 2035	in 8 yr 7 mo	ProductU-3454
10765750	Jan 08, 2035	in 8 yr 7 mo	Product
10774072	Jun 10, 2035	in 9 yr	Substance
12290511	Dec 27, 2038	in 12 yr 8 mo	U-3454
11666563	Jul 16, 2039	in 13 yr 2 mo	U-3454

FDA approval span

Approval history

First approval

Sep 22, 2022

3 yr 11 mo ago

Most recent approval

Sep 22, 2022

3 yr 11 mo ago

All 1 application were approved in 2022.

Brand (NDA) 1100%

Generic (ANDA) 00%

Omidenepag isopropyl — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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