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Orange Book drug · Brand (NDA)

Viberzi

Eluxadoline

RLDNDA 206940 2 strengths Abbvie
Approved
May 27, 2015
Strengths
2
Listed patents
14

What does the FDA Orange Book show for Viberzi?

Viberzi contains Eluxadoline and is the new drug FDA Orange Book record for NDA 206940. The application has 2 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 206940

New drug application identity from the Orange Book snapshot.

Application holder
Abbvie Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
2

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AB

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
14

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
00175MGTABLETORALPrescriptionAB
RLD
002100MGTABLETORALPrescriptionAB
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Abbvie Inc

The Orange Book identifies this organization as the applicant responsible for NDA 206940.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

2 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

14 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 14, 2033. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

2 other ANDAs and 0 other NDAs found

1 of the related ANDA application is not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 206940 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-206940

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

2 approved presentations · NDA 206940
TE ABRLD
Strength
75MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr 4 mo ago

  2. Today

  3. Patent 8691860 expires

    Listed drug substance patent expiration.

    in 2 yr

  4. Patent 9115091 expires

    Listed drug substance patent expiration.

    in 2 yr

  5. Patent 9364489 expires

    Listed method-of-use patent (U-1709) expiration.

    in 2 yr

  6. Patent 9789125 expires

    Listed drug product patent expiration.

    in 2 yr

  7. Patent 9789125 expires

    Listed drug product patent expiration.

    in 2 yr

  8. Patent 7741356 expires

    Listed drug substance patent expiration.

    in 2 yr 11 mo

  9. Patent 10188632 expires

    Listed drug product patent expiration.

    in 6 yr 9 mo

  10. Patent 11007179 expires

    Listed drug product patent expiration.

    in 6 yr 9 mo

  11. Patent 11090291 expires

    Listed drug product patent expiration.

    in 6 yr 9 mo

  12. Patent 11160792 expires

    Listed drug product patent expiration.

    in 6 yr 9 mo

  13. Patent 11229627 expires

    Listed drug product patent expiration.

    in 6 yr 9 mo

  14. Patent 11311516 expires

    Listed drug product patent expiration.

    in 6 yr 9 mo

  15. Patent 12097187 expires

    Listed method-of-use patent (U-3475) expiration.

    in 6 yr 9 mo

  16. Patent 9675587 expires

    Listed drug product patent expiration.

    in 6 yr 9 mo

Patent & exclusivity timeline

Protection horizon
202620272028202920302031203220332034TodayPatent 8691860: 2028-07-07Patent 8691860Patent 9115091: 2028-07-07Patent 9115091Patent 9364489: 2028-07-07Patent 9364489Patent 9789125: 2028-07-07Patent 9789125Patent 9789125: 2028-07-07Patent 9789125Patent 7741356: 2029-05-27Patent 7741356Patent 10188632: 2033-03-14Patent 10188632Patent 11007179: 2033-03-14Patent 11007179Patent 11090291: 2033-03-14Patent 11090291Patent 11160792: 2033-03-14Patent 11160792Patent 11229627: 2033-03-14Patent 11229627Patent 11311516: 2033-03-14Patent 11311516Patent 12097187: 2033-03-14Patent 12097187Patent 9675587: 2033-03-14Patent 9675587
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

ELUXADOLINE

Strength

75MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 206940

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8691860in 2 yr
SubstanceU-1709
9115091in 2 yr
SubstanceProductU-1738
9364489in 2 yr
U-1709
9789125in 2 yr
ProductU-2152
9789125in 2 yr
ProductU-1709
7741356in 2 yr 11 mo
SubstanceProduct
10188632in 6 yr 9 mo
Product
11007179in 6 yr 9 mo
Product
11090291in 6 yr 9 mo
Product
11160792in 6 yr 9 mo
Product
11229627in 6 yr 9 mo
Product
11311516in 6 yr 9 mo
Product
12097187in 6 yr 9 mo
U-3475
9675587in 6 yr 9 mo
Product

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Eluxadoline family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Viberzi: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 206940 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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