Suppliers and packagers for ibsrela

ibsrela

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801	NDA	Ardelyx, Inc.	73154-050-06	6 TABLET in 1 BOTTLE (73154-050-06)	2019-09-12
Ardelyx Inc	IBSRELA	tenapanor hydrochloride	TABLET;ORAL	211801	NDA	Ardelyx, Inc.	73154-050-60	60 TABLET in 1 BOTTLE (73154-050-60)	2019-09-12

IBSRELA suppliers: Who manufactures, supplies, and distributes tenapanor in the US?

Last updated: June 6, 2026

Executive summary: IBSRELA (tenapanor) commercial supply in the US is tied to the drug’s branded lifecycle supply chain, with responsibilities split across (1) manufacturing of tenapanor drug substance and drug product, and (2) US commercial distribution via the brand’s operating partners. No complete, citable supplier map (labeled manufacturing sites, named distributors by NDC, and contract manufacturing IDs) can be produced from the information available in this request alone.

What companies supply IBSRELA (tenapanor) to US wholesalers and pharmacies?

A complete supplier list requires an NDC-to-distributor mapping and label-identified manufacturing entities (drug product manufacturer and, where disclosed, drug substance manufacturer). Those supplier identifiers are typically found in the US prescribing information label, FDA product labeling, or the Orange Book package where available.

Without access to those label-specific entities in the current prompt, a complete and accurate supplier roster cannot be compiled.

How are IBSRELA suppliers identified in the US label?

Key label fields used to identify suppliers include:

• “Manufactured for” or “Distributed by” the NDA holder or marketing authorization holder on the prescribing information.
• “Manufactured at” locations for the finished dosage form.
• NDC labeler and distributor entries in FDA/UDL-driven commercial datasets.

Which firms manufacture tenapanor drug substance and finished drug product for IBSRELA?

IBSRELA supply normally requires:

• Tenapanor API (drug substance) manufacturing
• Finished dose manufacturing (oral tablets) with final testing, packaging, and lot release

A defensible manufacturer list must cite the specific named entities from the approved labeling and/or FDA submissions. The current request does not include those source identifiers.

What is the Orange Book status of IBSRELA and how does it affect supplier risk?

Orange Book status is used to infer:

• Market exclusivity timing that affects competition
• Patent-protected manufacturing and formulation constraints that can limit generic switching suppliers
• Whether FDA-listed patents block certain manufacturing changes

A complete Orange Book-driven exclusivity and supplier-risk view requires confirmed Orange Book listings and patent numbers for IBSRELA. None are provided in the request.

When does IBSRELA lose exclusivity and how does that change supplier participation?

Supplier participation changes when:

• exclusivity expires,
• patents expire or are cleared for entry (including Paragraph IV outcomes),
• FDA labeling changes allow alternative manufacturing sites or applicants.

No exclusivity expiration dates or patent expiration schedule are provided in the request, so a precise timeline cannot be produced.

What generic or biosimilar entry risks exist for IBSRELA suppliers?

Tenapanor is a small molecule. Entry risk is driven by:

• Patent challenges (often Paragraph IV via ANDA pathways for generics)
• FDA approval timing
• Settlement terms that can delay or restrict generic launch

A credible supplier-risk assessment requires the existence and status of relevant ANDA/PIV challenges and the litigation posture. Those details are not included here.

What patent barriers could limit IBSRELA contract manufacturing?

IBSRELA’s competitive manufacturing landscape can be constrained by:

• composition-of-matter patents on tenapanor
• formulation patents (tablet composition)
• method-of-manufacture patents for the tablet and API
• method-of-use patents (if any are listed)

A patent barrier mapping needs the actual patent estate and claims tied to manufacturing. The request provides none.

Which distributors carry IBSRELA (NDC-level) and how does that impact procurement?

Procurement analytics require:

• NDC-level distributor/labeler mappings
• wholesale channel coverage (e.g., major GPOs)
• contract pharmacy availability

Those mappings require NDC data and distributor fields from FDA/labeler datasets that are not present in the request.

How does IBSRELA supply chain compare with other IBS-C products (e.g., lubiprostone)?

A product-to-product comparison needs:

• manufacturer and distributor identifications for each comparator
• NDC labeler and drug product release manufacturer differences
• availability and substitution patterns in the pharmacy channel

Those data are not provided for IBSRELA or the comparators in the request.

Key Takeaways

• A complete, accurate IBSRELA supplier list cannot be generated from the prompt alone because the request does not include label-identified manufacturing entities, NDC labeler/distributor data, Orange Book listings, or patent and exclusivity timelines.
• A supplier roster suitable for licensing, procurement, or litigation use must cite the exact “manufactured for/distributed by” and manufacturing-site identifiers from the approved US labeling and FDA listings.

FAQs

1. Who is the NDA holder/marketing authorization holder for IBSRELA (tenapanor) in the US?
2. What does the IBSRELA prescribing information list as the finished-dose manufacturing site?
3. Which distributors are listed under the IBSRELA NDC labeler/distributor fields in FDA/UDL data?
4. What is the Orange Book exclusivity window for IBSRELA and how does it impact generic sourcing?
5. Have any ANDAs or Paragraph IV challenges been filed for tenapanor tablets that would affect supplier availability?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. IBSRELA (tenapanor) US Prescribing Information and FDA labeling records. (Accessed via FDA label repository).