Is there a generic for Nirogacestat hydrobromide?

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

What is the reference-listed drug for Nirogacestat hydrobromide?

OGSIVEO (NDA 217677, SPRINGWORKS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Nirogacestat hydrobromide?

The Orange Book lists 29 patents against Nirogacestat hydrobromide products, with the earliest listed expiry in 2030. 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 Nirogacestat hydrobromide have FDA marketing exclusivity?

Yes. The Orange Book records 6 marketing-exclusivity periods for Nirogacestat hydrobromide. 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 Nirogacestat hydrobromide are approved?

Nirogacestat hydrobromide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Nirogacestat hydrobromide

Nirogacestat hydrobromide: 1 brand, 0 generics; first approved Nov 27, 2023; on patent until Aug 18, 2030.

On patent6 exclusivity periodsHas discontinued products

Generic status & protection

Protected until Aug 18, 2030 (earliest listed patent expiry).

Earliest patent expiry Aug 18, 2030Latest exclusivity ends Nov 27, 2030

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 18, 2030

in 4 yr 2 mo

Originator applications

Brand (NDA) products

OGSIVEORLD

SPRINGWORKSNDA 21767720233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE	TABLET	ORAL	Discontinued	—
EQ 100MG BASE	TABLET	ORAL	Rx	—
EQ 150MG BASE	TABLET	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (6)

NCENew chemical entity exclusivity (5 years)
Nov 27, 2028
in 2 yr 5 mo
ODE-452Orphan-drug exclusivity (7 years)
Nov 27, 2030
in 4 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2028
in 2 yr 5 mo
ODE*FDA marketing exclusivity
Nov 27, 2030
in 4 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2028
in 2 yr 5 mo
ODE*FDA marketing exclusivity
Nov 27, 2030
in 4 yr 5 mo

Orange Book patent file

Listed patents

Listed patents (29)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7795447	Aug 18, 2030	in 4 yr 2 mo	Substance
10941118	Aug 09, 2039	in 13 yr 3 mo	SubstanceU-3754
10710966	Aug 09, 2039	in 13 yr 3 mo	SubstanceU-3754
11845732	Aug 09, 2039	in 13 yr 3 mo	SubstanceU-3754
11884635	Aug 09, 2039	in 13 yr 3 mo	Product
11884634	Aug 09, 2039	in 13 yr 3 mo	Product
11905255	Aug 09, 2039	in 13 yr 3 mo	Product
11820748	Aug 09, 2039	in 13 yr 3 mo	Product
10590087	Aug 09, 2039	in 13 yr 3 mo	Substance
12297177	Aug 09, 2039	in 13 yr 3 mo	Product
12116347	Aug 09, 2039	in 13 yr 3 mo	Product
11612588	Jul 08, 2042	in 16 yr 2 mo	ProductU-3754
12247012	Jul 08, 2042	in 16 yr 2 mo	Product
12110277	Jul 08, 2042	in 16 yr 2 mo	Product
12234210	Jul 08, 2042	in 16 yr 2 mo	Product
12599587	Jul 08, 2042	in 16 yr 2 mo	Product
11504354	Jul 08, 2042	in 16 yr 2 mo	Product
11807611	Sep 08, 2042	in 16 yr 5 mo	ProductU-3754
11844780	Sep 08, 2042	in 16 yr 5 mo	ProductU-3754
12138246	May 19, 2043	in 17 yr 1 mo	U-3754
12011435	May 19, 2043	in 17 yr 1 mo	U-3754
12011434	May 19, 2043	in 17 yr 1 mo	U-3754
11925620	May 19, 2043	in 17 yr 1 mo	U-3754
11925619	May 19, 2043	in 17 yr 1 mo	U-3754
11938116	May 19, 2043	in 17 yr 1 mo	U-3754
11957662	May 19, 2043	in 17 yr 1 mo	U-3754
11951096	May 19, 2043	in 17 yr 1 mo	U-3754
12036207	May 19, 2043	in 17 yr 1 mo	U-3754
11872211	May 19, 2043	in 17 yr 1 mo	U-3754

FDA approval span

Approval history

First approval

Nov 27, 2023

2 yr 8 mo ago

Most recent approval

Apr 04, 2024

2 yr 4 mo ago

Approvals span 2023–2024 across 1 FDA application.

Brand (NDA) 1100%

Generic (ANDA) 00%

Nirogacestat hydrobromide — 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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