Last updated: April 26, 2026
Who Supplies Isentress (Raltegravir): Manufacturer and Input Chain
What company makes Isentress?
Isentress (raltegravir) is marketed as a prescription antiretroviral. In the US market, the product’s primary manufacturer has been:
- Merck Sharp & Dohme (MSD)
- The brand is built around raltegravir, with MSD as the marketing authorization holder and the core brand manufacturer in labeling and regulatory listings. (See US FDA label references below.)
- US FDA label for Isentress lists Merck Sharp & Dohme Corp. as the manufacturer. (US FDA: Isentress Prescribing Information) [1]
Who supplies the drug substance and key manufacturing services?
For “suppliers” in the patent-and-supply-chain sense, the most verifiable, decision-grade data comes from regulatory label manufacturing statements (drug product) and from official filings that identify manufacturers.
1) Drug product manufacturing (finished dosage form)
Isentress tablets (raltegravir)
- Manufacturer listed in US FDA prescribing information: Merck Sharp & Dohme Corp. [1]
2) Over-the-counter visibility into drug substance suppliers
Public-facing regulatory labels typically identify the finished product manufacturer rather than all upstream API suppliers. For raltegravir, the most direct supplier attribution that can be supported from public regulatory labeling is the brand manufacturer of record, not an exhaustive API vendor list.
- The US FDA labeling states manufacturing responsibility through Merck Sharp & Dohme for the marketed tablets. [1]
What is the supplier map for Raltegravir (Isentress) in the US?
| Supply layer |
Supplier identity supported by public sources |
Evidence basis |
| Brand drug product (finished tablets) |
Merck Sharp & Dohme Corp. |
US FDA prescribing information identifies the manufacturer of record. [1] |
| Upstream API and subcontractors |
Not enumerated in US label text |
Regulatory label typically does not list every API source in the main prescribing document. [1] |
What can be asserted about upstream suppliers using patent-facing source lists?
Patent and supply-chain diligence for complex ARVs often uses:
- FDA labeling manufacturing statements (most reliable for “who makes the branded product”)
- AND supply-chain databases and separate regulatory sections (for API plants and DMF-linked sites)
In the accessible FDA label content for Isentress, the manufacturer-of-record for the branded product is attributed to Merck Sharp & Dohme Corp. [1]. That is the only supplier-level statement that is consistently supported from the primary public regulatory label cited below.
Sources (FDA Label Basis)
- U.S. Food and Drug Administration. Isentress (raltegravir) prescribing information. (Manufacturer information shown in label.) [Accessed via FDA label content] [1]
Key Takeaways
- Merck Sharp & Dohme Corp. is the supplier/manufacturer of record for Isentress tablets in the US FDA prescribing information. [1]
- Public regulatory label text identifies the finished drug product manufacturer; it does not provide a complete enumerated list of upstream API suppliers in the main prescribing information. [1]
FAQs
1) Who is the manufacturer of Isentress in the US?
Merck Sharp & Dohme Corp. is listed as the manufacturer in the US FDA prescribing information. [1]
2) Is Isentress manufactured by multiple suppliers?
The US FDA prescribing information provides the manufacturer of record as Merck Sharp & Dohme Corp.. [1]
3) Who supplies the raltegravir active ingredient (API)?
The US FDA prescribing information cited here identifies the finished drug product manufacturer, not a full API supplier roster. [1]
4) Where does Isentress supply chain diligence typically start?
From the US FDA label manufacturing statements for the branded product manufacturer of record, then layered with DMF and site-level data where available. [1]
5) Does the supplier change by dosage form or market?
Supplier-of-record statements can vary by market and dosage form; the cited source supports the US label manufacturer-of-record as Merck Sharp & Dohme Corp. [1]
References
[1] U.S. Food and Drug Administration. Isentress (raltegravir) Prescribing Information (manufacturer information shown in label).
