Is there a generic for Eluxadoline?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Eluxadoline, referencing the brand VIBERZI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Eluxadoline?

VIBERZI (NDA 206940, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Eluxadoline?

The Orange Book lists 14 patents against Eluxadoline products, with the earliest listed expiry in 2028. 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.

What dosage forms of Eluxadoline are approved?

Eluxadoline is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Eluxadoline

Eluxadoline: 1 brand, 2 generics; first approved May 27, 2015; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 2 ANDA applications approved.

Earliest patent expiry Jul 07, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 07, 2028

in 2 yr

Originator applications

Brand (NDA) products

VIBERZIRLD

ABBVIENDA 20694020152 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
75MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (2)

ELUXADOLINE

AUROBINDO PHARMAANDA 21351120262 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
75MG	TABLET	ORAL	Rx	AB
100MG	TABLET	ORAL	Rx	AB

ELUXADOLINE

ZYDUS PHARMSANDA 21352220252 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
75MG	TABLET	ORAL	Discontinued	—
100MG	TABLET	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9115091	Jul 07, 2028	in 2 yr	SubstanceProductU-1738
9364489	Jul 07, 2028	in 2 yr	U-1709
9789125	Jul 07, 2028	in 2 yr	ProductU-2152
8691860	Jul 07, 2028	in 2 yr	SubstanceU-1709
7741356	May 27, 2029	in 2 yr 11 mo	SubstanceProduct
12097187	Mar 14, 2033	in 6 yr 9 mo	U-3475
11007179	Mar 14, 2033	in 6 yr 9 mo	Product
11311516	Mar 14, 2033	in 6 yr 9 mo	Product
9675587	Mar 14, 2033	in 6 yr 9 mo	Product
11229627	Mar 14, 2033	in 6 yr 9 mo	Product
11160792	Mar 14, 2033	in 6 yr 9 mo	Product
10188632	Mar 14, 2033	in 6 yr 9 mo	Product
11090291	Mar 14, 2033	in 6 yr 9 mo	Product
11484527	Mar 14, 2033	in 6 yr 9 mo	U-3475

FDA approval span

Approval history

First approval

May 27, 2015

11 yr 4 mo ago

Most recent approval

Jun 02, 2026

1 mo ago

Approvals span 2015–2026 across 3 FDA applications.

Brand (NDA) 133%

Generic (ANDA) 267%

Eluxadoline — 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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