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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075-08	1 BLISTER PACK in 1 CARTON (61874-075-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK	2015-10-01
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075-16	1 BLISTER PACK in 1 CARTON (61874-075-16) / 16 TABLET, FILM COATED in 1 BLISTER PACK	2015-10-01
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075-60	1 BOTTLE in 1 CARTON (61874-075-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2015-10-01
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-100-08	1 BLISTER PACK in 1 CARTON (61874-100-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK	2015-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

ecutive summary
Eluxadoline (Viberzi; Allergan) has a concentrated, vertically linked supply chain. API supply is typically tied to specialty chemical capability and controlled intermediates for the substituted morpholine-benzamide scaffold, with finished-dose sourcing often handled by a limited set of contract manufacturers for tablets. Patent-driven process constraints and FDA quality system requirements tend to narrow switch-ready second sources for both eluxadoline drug substance and eluxadoline tablets.

Eluxadoline suppliers: who manufactures the API and Viberzi tablets for 2026?

Key sourcing reality for eluxadoline: upstream API and downstream tablet manufacturing are usually performed by a small number of qualified plants with validated processes. For commercial planning, the actionable target is not “generic suppliers,” but (1) registered API manufacturers for eluxadoline used in the FDA-licensed NDA product and (2) CMO/CMG tablet manufacturers that produce strength-specific commercial lots.

Who supplies eluxadoline drug substance (API) for the NDA product?

Featured-snippet answer: eluxadoline API is supplied by firms capable of synthesizing and purifying the morpholine-containing, substituted benzamide chemical series and meeting NDA/CGMP release specifications.

For practical diligence, eluxadoline API vendors are identified through:

FDA drug substance “manufacturing sites” listed in the NDA/CMC section (and updated via supplements).
Lot release and labeling manufacturing statements tied to commercial batches.
DMF linkages where the supplier has an active DMF referencing the eluxadoline drug substance.

Who supplies eluxadoline tablets (finished dosage forms)?

Featured-snippet answer: eluxadoline tablets are produced by one or more FDA-inspected tablet manufacturing sites (CMOs or Allergan sites), with strength-specific packaging handled under finished product release responsibility.

What manufacturing categories dominate the eluxadoline supply chain?

Drug substance: specialty chemistry + impurity control + salt/solvated form management for eluxadoline free base form.
Finished product: tablet compression, coating (if applicable), and robust dissolution/performance testing to match reference specifications.
Packaging and labeling: NDC-specific bottle/blister operations under the marketing authorization holder’s release.

Which suppliers are typically “switch-ready” for eluxadoline?

In practice, switch-ready suppliers are those with:

Prior FDA inspections for similar controlled substances or complex APIs,
Demonstrated impurity clearance and process validation history,
Proven ability to scale without drifting impurity profile,
Experience with tablet formulation and dissolution matching for sparingly soluble small molecules.

What companies make eluxadoline for Viberzi in the US and how is responsibility assigned?

How does the NDA assign responsibility between marketing holder, API supplier, and CMO?

Featured-snippet answer: the NDA holder (Allergan at launch) holds regulatory responsibility; the API supplier provides drug substance under validated controls, and the CMO provides drug product manufacturing under defined quality agreements.

Typical documentation trail that names suppliers

Labeling and package inserts often show manufacturer/distributor and sometimes the tablet manufacturing site.
CMC supplements can update manufacturing locations.
FDA databases (NDC labeler records and inspection histories) can map finished-goods plants.

US market responsibility split for eluxadoline

Marketing authorization: Allergan (historical; later branded marketing may shift with corporate changes).
Manufacturing responsibility: split between drug substance sites and finished-dose sites that produce commercial lots.

How many eluxadoline API suppliers exist and what are the supplier concentration risks?

What is the supplier concentration pattern for eluxadoline?

Featured-snippet answer: the number of qualified sources is typically small, creating supply concentration risk for API and commercial tablets.

What risks matter most for eluxadoline sourcing?

API single-site dependence: disruption in specialized chemical steps or key intermediates.
Impurity profile sensitivity: process changes can force revalidation and regulatory changes.
Tablet performance risk: formulation changes can affect dissolution and require bridging.

How do commercial lot release and stability requirements constrain new entrants?

Eluxadoline requires:

CGMP lot-by-lot release controls,
Stability-indicating assays,
Dissolution and impurity specifications aligned to the NDA.

What patents affect eluxadoline manufacturing and limit alternative suppliers?

How does the eluxadoline patent estate influence sourcing?

Featured-snippet answer: eluxadoline manufacturing alternatives face both chemistry process control and regulatory reliance constraints, even when there is no direct “production exclusivity” that blocks contract manufacturing.

For manufacturing sourcing, the operational impact comes from:

Process patents: if method claims cover key synthesis steps, a supplier may avoid infringing routes or license them.
Formulation patents: may constrain excipient systems, granulation, coating, and compression parameters.
Method-of-use patents: can influence life-cycle strategies but typically do not block manufacturing of the drug substance itself.

Where do formulation and method-of-use patents matter for suppliers?

Finished dose CMOs need freedom to manufacture to NDA specs without infringing relevant formulation method claims.
If branded life-cycle patents are in force, generics or authorized equivalents may require design-around strategies.

What is the Orange Book status of eluxadoline and does it affect supplier eligibility?

Does Orange Book exclusivity block API or CMO sourcing?

Featured-snippet answer: Orange Book patents and exclusivities do not “block suppliers” from making eluxadoline API for the marketing holder under contract, but they can block generic applicants and biosimilar-style pathways. Supplier eligibility for contract manufacturing still depends on regulatory and legal clearance.

How does Orange Book timing drive long-term sourcing?

As patents near expiration, more firms may qualify for commercial supply. In the interim, sourcing remains concentrated due to:

Qualification burden for new sites,
Regulatory change-management friction,
Patent landscape that affects alternative product approvals more than direct contract manufacturing.

How do generic entry risks affect eluxadoline supplier strategy?

What generic entry risks exist for eluxadoline?

Featured-snippet answer: generic entry risk depends on the patent/Orange Book landscape and whether Paragraph IV challenges are filed for eluxadoline tablets. Even if generic approval occurs, manufacturing qualification and bioequivalence testing constrain timelines.

How could Paragraph IV challenges change sourcing?

If a generic NDA is approved:

The generic marketer will qualify its own API and tablet manufacturing sites,
But API sourcing can still concentrate if only a few plants can meet impurity and cost targets.

What manufacturing barriers most often delay eluxadoline generics?

API impurity control and process validation
Tablet dissolution equivalency and excipient compatibility
Scale-up reproducibility and stability commitments

How does FDA regulatory status shape who can supply eluxadoline?

What FDA requirements constrain eluxadoline suppliers?

Featured-snippet answer: CGMP compliance, validated manufacturing, and site inspections constrain suppliers more than corporate brand relationships.

Supplier gating criteria

FDA inspection outcomes
DMF or site master file status for the API
Quality agreement structure
Ability to meet NDA release specs

How are eluxadoline suppliers approved or qualified for commercial lots?

The NDA holder or its quality unit audits suppliers.
Change control is managed through supplements and comparability packages if needed.
Release testing includes chemical and performance indicators.

Which eluxadoline tablet strengths and dosage forms matter for sourcing?

Does eluxadoline come in multiple tablet strengths that change supplier needs?

Featured-snippet answer: strength-specific manufacturing can require separate validation ranges for tablet weight, coating/appearance specs, and process parameter windows.

How do strength differences affect manufacturing qualification?

Compression force profiles
Coating thickness and drying times
Dissolution profiles and particle-size distribution controls

Comparison: eluxadoline sourcing vs other IBS-D drugs (what differs in supplier burden)?

How does eluxadoline supply compare with similar GI small molecules?

Featured-snippet answer: eluxadoline has a mid-to-high supplier burden due to specialty chemistry and performance specs, while some comparator GI actives may have more generic-friendly synthesis routes.

Common differences across IBS-D and related GI drugs:

API route complexity and impurity sensitivity
Tablet dissolution performance requirements
Patent-life-cycle constraints on process/formulation

What litigation or settlements could affect eluxadoline supply contracts?

How can patent litigation affect sourcing even when production is technically feasible?

Featured-snippet answer: litigation can restrict market participation or trigger licensing/design-around requirements, which can delay qualification of alternative sources.

Practical supply-chain impacts

Suppliers may seek non-infringing process routes or licenses
Contract manufacturers may limit work until patent positions clear
Authorized generic or settlement terms can shift who qualifies for commercial volume

Key Takeaways

Eluxadoline sourcing is typically concentrated across a small number of qualified API plants and tablet manufacturers with validated, CGMP-compliant processes.
Patent and life-cycle constraints mainly affect alternative approvals and process freedom, shaping the breadth of switch-ready suppliers over time.
For supplier due diligence, the most actionable path is mapping FDA-registered manufacturing sites and NDA-linked drug substance controls rather than relying on generic supplier lists.

FAQs

How do I find the FDA-registered eluxadoline API manufacturing sites tied to the NDA?
Can contract manufacturers legally produce eluxadoline tablets during active eluxadoline patent life?
What CGMP documentation must eluxadoline API suppliers provide under a quality agreement?
How do formulation differences by eluxadoline tablet strength affect CMO qualification?
What supply-chain risks increase during eluxadoline generic transition periods?

References

FDA. Orange Book: Eluxadoline (Viberzi). US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
FDA. Drugs@FDA: Viberzi (eluxadoline). US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
FDA. Drug Master Files (DMF) overview. US Food and Drug Administration. https://www.fda.gov/drugs/ingredient-submission-requirements/drug-master-files-dmfs