Enclomiphene Citrate Patent Field and Generic Timeline

Is There a Generic Enclomiphene Citrate?

No. FDA's June 8, 2022 advisory-committee presentation states that no FDA-approved drugs contain enclomiphene as an active ingredient [1]. A generic is an approved copy of an approved reference product, so with no approved enclomiphene product there is no reference product, no generic, and no patent-based approval date.

A patent expiry would not set a generic date by itself; an approved reference product would have to come first. Clomiphene citrate, the related mixture, is FDA-approved only for ovulatory dysfunction in women [5], and that approval creates no enclomiphene pathway. Clomiphene is a mixture of enclomiphene and zuclomiphene, and enclomiphene is not simply clomiphene [1].

The Regulatory Record

Repros Therapeutics submitted a new drug application for enclomiphene (Androxal) for secondary hypogonadism in fertile men [1]. In 2015, Repros announced that FDA had issued a complete response letter; as summarized by FDA, the letter said the design of the phase 3 studies was not adequate to demonstrate clinical benefit and raised concerns about study entry criteria, titration and bioanalytical method validation [1]. No FDA approval has followed [1].

In Europe, EMA's committee adopted a negative opinion on 25 January 2018 recommending refusal of marketing authorisation for EnCyzix (enclomifene) for hypogonadotropic hypogonadism in overweight men with BMI at least 25 [3]. The stated reasons were that the studies showed higher testosterone but did not look at whether symptoms improved, and that there was a risk of venous thromboembolism; the review was based on 4 main studies in 588 patients [3].

A 2026 British Society of Sexual Medicine position statement says enclomiphene is not currently approved by the FDA or EMA and that its manufacturer discontinued development in 2021 [2].

Compounding Is Not a Generic Approval

FDA lists enclomiphene citrate in Category 1, 'Bulk Drug Substances Under Evaluation', in a list updated May 14, 2026 [4]. FDA says it does not intend to take action against a compounder using a Category 1 substance if the conditions in its guidance are met; that is an enforcement-discretion policy, not an approval and not a finding that the product is safe or effective [4]. Compounded drugs, including compounded enclomiphene, are not FDA-approved; FDA does not verify their safety, effectiveness or quality before they are marketed [6].

At the FDA Pharmacy Compounding Advisory Committee meeting on June 8, 2022, FDA proposed that enclomiphene citrate not be added to the list of allowed bulk substances, and the committee voted 4 yes, 8 no, 0 abstain [7].