Last updated: May 27, 2026
Oseni (alogliptin + pioglitazone) suppliers: API, formulation, and contract manufacturing landscape
Oseni is a fixed-dose combination of the DPP-4 inhibitor alogliptin and the thiazolidinedione pioglitazone. Supplier mapping depends on whether the demand is for (1) API supply, (2) tablet manufacturing (finished dose), or (3) packaging and distribution. Public, verifiable supplier detail is limited unless an applicant/labeler’s manufacturing sites and Orange Book “manufacturing” listings are used.
What manufacturers supply Oseni tablets (finished-dose) to the US market?
Answer (based on publicly citable labeler/manufacturer data): Oseni is marketed in the US by Takeda Pharmaceuticals (labeler/manufacturer appearing on US prescribing information). Tablet production is typically performed by Takeda and/or designated contract manufacturers listed in regulatory filings.
Where to extract finished-dose suppliers (most defensible sources):
- FDA Prescribing Information (US label) for company responsible for manufacture/distribution.
- FDA Orange Book (for which applicants list specific products and any listed manufacturing-related data).
- FDA Drug Establishment Registration and Listing (DERL) for manufacturing sites tied to the product.
How do Oseni strength and dosage form change supplier assignments?
Oseni is supplied as oral tablets. Supplier substitutions are usually tied to:
- Different strength SKUs (the same API suppliers can serve multiple strengths).
- Scale-up batch plans for a given strength.
- Site qualification and validation cycles after process changes.
Do packaging and distribution count as “suppliers”?
For procurement decisions, “supplier” can mean:
- Tablet manufacturing site (API to finished dosage).
- Packaging site (blistering, bottling, secondary packaging).
- Distribution (wholesaler or logistics subcontractor).
These are different in DERL and are often miscategorized in commercial directories.
Who supplies alogliptin API for Oseni?
Answer: Oseni uses alogliptin as a standalone API within the fixed-dose combination; the API is sourced from specialized API manufacturers. Direct identification of the specific alogliptin API suppliers used by the US commercial tablet site requires Orange Book tied manufacturing details, Takeda’s CMC disclosures, or DERL-linked site inspection records.
What to look for in API supplier evidence
A supplier list that holds up in diligence typically uses one or more of:
- Orange Book listing tied to the application and manufacturer
- DERL site that explicitly manufactures the API or the finished dose
- Public DMF references (where the DMF holder is named in FDA documents or in litigation exhibits)
What competitive API suppliers exist for alogliptin (market structure)?
Alogliptin is manufactured by a limited set of capable API producers given the synthesis and impurity controls for DPP-4 inhibitors. Supplier qualification is driven by:
- DMF status and cross-referenced filings
- Particle and polymorph control
- Stability and degradation impurity profiles
Who supplies pioglitazone API for Oseni?
Answer: Oseni uses pioglitazone API, a mature generic API with a broader supplier base than alogliptin. As with alogliptin, the specific API suppliers used in Oseni’s commercial supply chain require DERL and/or Orange Book-linked manufacturing data to be stated with confidence.
How does pioglitazone API sourcing affect compliance risk?
For procurement and regulatory risk mapping, pioglitazone sourcing impacts:
- Impurity and residual solvent specifications
- Polymorphic form control
- Variation in impurity patterns across suppliers
- Traceability and GMP batch record alignment at the finished-dose plant
Which contract manufacturing organizations produce Oseni tablets?
Answer: The finished-dose supplier for Oseni tablets is typically either:
- A Takeda manufacturing site, or
- A contract manufacturer designated through GMP manufacturing arrangements.
To identify a specific CMO name for Oseni tablets in the US, the correct evidentiary path is:
- FDA label’s “Manufactured for” / “Distributed by” sections, and
- DERL manufacturing site matching the product’s labeler/application.
What Orange Book listings show about Oseni manufacturing and exclusivity?
Answer: Orange Book provides the legal status and (in some listings) identifies the application and reference products that relate to manufacturing and exclusivity. Orange Book listings also support:
- Patent-by-patent mapping for combination products
- Potential generic entry risks through Paragraph IV
Why supplier mapping is constrained by the Orange Book format
Orange Book is legally oriented and may not publish a full supplier chain. For supplier diligence, Orange Book must be paired with:
- FDA DERL site data
- Facility names in CMC or litigation records
Do Oseni generics or authorized versions change supplier availability?
Answer: Generic or authorized combination versions can shift supply dynamics by:
- Replacing the original finished-dose plant with generic manufacturer sites
- Increasing pressure on API pricing
- Creating parallel qualification for alogliptin and pioglitazone sources
Supplier changes typically happen after:
- Patents and exclusivity barriers clear
- ANDA sites receive approval and scale up through multiple commercial lots
What patent estate constraints affect generic supplier choices for Oseni?
Answer: Oseni’s fixed-dose combination carries its own IP barriers across:
- Product patents on the combination
- Formulation and manufacturing method patents (where present)
- Method-of-use patents related to DPP-4 inhibitor and thiazolidinedione use
These barriers influence which manufacturers can legally produce and supply generic or authorized versions.
How strong is the Oseni patent estate versus generic and biosimilar entry risk?
Answer: Oseni is a small-molecule product, not a biologic, so “biosimilar” risk does not apply. The real risk drivers are:
- ANDA entry timing relative to listed patents and exclusivity
- Paragraph IV settlements that can delay market entry
What litigation or settlements affect Oseni generic launch timing (and therefore supplier strategy)?
Answer: Generic launch and supplier strategy are shaped by ANDA Paragraph IV litigation and settlements. For accurate, actionable launch-timing mapping, the docket history and settlement terms tied to the Orange Book patents are required.
Oseni sourcing checklist for procurement and due diligence
- Identify whether the requirement is API or finished-dose.
- Use FDA label for labeler and manufacturing/distribution entity.
- Use FDA DERL to map manufacturing sites to the product.
- Use Orange Book to connect the product to the correct application(s) and patent context.
- For API, use DMF-linked evidence or DERL sites that explicitly manufacture API.
Key Takeaways
- Oseni is a fixed-dose tablet of alogliptin + pioglitazone marketed under Takeda in the US.
- A defensible supplier list must distinguish finished-dose manufacturer/CMO from API suppliers.
- Publicly citable supplier attribution requires linking to FDA label, Orange Book, and DERL manufacturing site data; generic supplier directories alone are not audit-grade for IP or regulatory diligence.
- Generic entry timing and supplier flexibility depend on Orange Book patent and exclusivity status and any ANDA Paragraph IV litigation/settlements tied to Oseni’s combination product.
FAQs
- Which company holds the US Oseni (alogliptin/pioglitazone) NDA/labeler status?
- How can I identify the Oseni finished-dose manufacturing site using FDA DERL data?
- Do alogliptin and pioglitazone for Oseni come from the same API suppliers across strengths?
- What Orange Book patents are most relevant to Oseni generic ANDA timing?
- What documents typically confirm the specific API DMF holder(s) for alogliptin used in Oseni?
References (APA)
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA. (n.d.). Drug Registration and Listing System (DRLS) / Drug Establishment Registration and Listing (DERL). U.S. Food and Drug Administration.
- FDA. (n.d.). Prescribing Information (Oseni). U.S. Food and Drug Administration.
