Elagolix Sodium API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Orilissa, Oriahnn

Category: Active Pharmaceutical Ingredient

Elagolix sodium is an oral GnRH receptor antagonist used in women's health products. It is sourced by hormone formulators, CDMOs and R&D teams with contained facilities.

Product Description:

Elagolix is an oral, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces the release of pituitary hormones and so lowers oestrogen levels. It is approved in the US for moderate to severe pain associated with endometriosis (reference brand: Orilissa) and, combined with estradiol and norethindrone acetate, for heavy menstrual bleeding associated with uterine fibroids in premenopausal women (reference brand: Oriahnn).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 21 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (Jul 2029). European Union: No confirmed date.

Handling and quality points

Elagolix acts on the reproductive hormone axis, so it is usually handled as a potent compound with reproductive-toxicity controls, closed transfers and verified cleaning, especially on shared lines. The sodium salt can take up moisture, so water content, packing and storage conditions need attention. The specification should include chiral purity and control of the synthesis impurities identified in the supplier's ICH M7 assessment.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.