Is there a generic for Navepegritide?

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

What is the reference-listed drug for Navepegritide?

YUVIWEL (NDA 219164, ASCENDIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Navepegritide?

The Orange Book lists 12 patents against Navepegritide products, with the earliest listed expiry in 2031. 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 Navepegritide have FDA marketing exclusivity?

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

Navepegritide is approved in the following dosage form: powder.

FDA Orange Book · active-ingredient family

Navepegritide

Navepegritide: 1 brand, 0 generics; first approved Feb 27, 2026; on patent until Apr 30, 2031.

On patent6 exclusivity periods

Generic status & protection

Protected until Apr 30, 2031 (earliest listed patent expiry).

Earliest patent expiry Apr 30, 2031Latest exclusivity ends Feb 27, 2033

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Apr 30, 2031

in 4 yr 10 mo

Originator applications

Brand (NDA) products

YUVIWELRLDRS

ASCENDISNDA 21916420263 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.3MG/VIAL	POWDER	SUBCUTANEOUS	Rx	—
2.8MG/VIAL	POWDER	SUBCUTANEOUS	Rx	—
5.5MG/VIAL	POWDER	SUBCUTANEOUS	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (6)

NCENew chemical entity exclusivity (5 years)
Feb 27, 2031
in 4 yr 8 mo
ODE-516Orphan-drug exclusivity (7 years)
Feb 27, 2033
in 6 yr 9 mo
NCENew chemical entity exclusivity (5 years)
Feb 27, 2031
in 4 yr 8 mo
ODE-516Orphan-drug exclusivity (7 years)
Feb 27, 2033
in 6 yr 9 mo
NCENew chemical entity exclusivity (5 years)
Feb 27, 2031
in 4 yr 8 mo
ODE-516Orphan-drug exclusivity (7 years)
Feb 27, 2033
in 6 yr 9 mo

Orange Book patent file

Listed patents

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8906847	Apr 30, 2031	in 4 yr 10 mo	SubstanceProductU-4425
12239689	Jan 05, 2037	in 10 yr 7 mo	U-4425
12156917	Jan 05, 2037	in 10 yr 7 mo	U-4425
10835578	Jan 05, 2037	in 10 yr 7 mo	SubstanceProductU-4425
11154593	Jan 05, 2037	in 10 yr 7 mo	SubstanceProductU-4425
12083182	Jan 05, 2037	in 10 yr 7 mo	U-4425
11311604	Jan 05, 2037	in 10 yr 7 mo	SubstanceProductU-4425
11389511	Jan 05, 2037	in 10 yr 7 mo	ProductU-4425
11224661	Jan 05, 2037	in 10 yr 7 mo	SubstanceProduct
11413351	Jan 05, 2037	in 10 yr 7 mo	SubstanceProduct
11389510	Jan 05, 2037	in 10 yr 7 mo	SubstanceProduct
12377133	Nov 12, 2042	in 16 yr 7 mo	ProductU-4425

FDA approval span

Approval history

First approval

Feb 27, 2026

5 mo ago

Most recent approval

Feb 27, 2026

5 mo ago

All 1 application were approved in 2026.

Brand (NDA) 1100%

Generic (ANDA) 00%

Navepegritide — 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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