Is there a generic for Triclabendazole?

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

What is the reference-listed drug for Triclabendazole?

EGATEN (NDA 208711, NOVARTIS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

Does Triclabendazole have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Triclabendazole. 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 Triclabendazole are approved?

Triclabendazole is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Triclabendazole

Triclabendazole: 1 brand, 0 generics; first approved Feb 13, 2019.

Brand only1 exclusivity period

Generic status & protection

Marketing exclusivity runs through Feb 13, 2026.

Latest exclusivity ends Feb 13, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

EGATENRLDRS
NOVARTISNDA 2087112019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
250MG TABLET ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Rx	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

ODE-228Orphan-drug exclusivity (7 years)
Feb 13, 2026
5 mo ago

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Feb 13, 2019

7 yr 7 mo ago

Most recent approval

Feb 13, 2019

7 yr 7 mo ago

All 1 application were approved in 2019.

Brand (NDA) 1100%

Generic (ANDA) 00%

Triclabendazole: 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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