FDA Approves Generic Enzalutamide Tablets, Including Higher-Strength Options

Lupin Limited has received tentative approval from the FDA for its abbreviated new drug application (ANDA) for enzalutamide (Xtandi) tablets in 4 strengths: 40 mg, 80 mg, 120 mg, and 160 mg.¹

The 40 mg and 80 mg formulations were approved as bioequivalent to the reference listed drug. The 120 mg and 160 mg strengths are not currently available in the branded tablet formulation and would offer alternative dosing configurations for prescribers and patients if final approval is granted.

Tentative approval indicates that the ANDA meets all required quality, safety, and efficacy standards but that final approval is deferred pending the expiration of applicable patents or exclusivity periods protecting the reference listed drug.

Clinical Context

Enzalutamide is an androgen receptor pathway inhibitor (ARPI) indicated for 3 prostate cancer settings: castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC), and nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis.² The recommended dosage per the current prescribing information is 160 mg administered orally once daily. For CRPC and mCSPC, concurrent gonadotropin-releasing hormone (GnRH) analog therapy as androgen deprivation therapy (ADT) or prior bilateral orchiectomy is required; in nmCSPC with high-risk biochemical recurrence, enzalutamide may be used with or without a GnRH analog, with a treatment suspension option for patients who achieve undetectable prostate-specific antigen (PSA) after 36 weeks.

The 160 mg daily dose can currently be achieved using four 40 mg tablets or two 80 mg tablets of the branded formulation. Lupin's tentatively approved 120 mg and 160 mg strengths would allow the full daily dose to be delivered in fewer tablets, a potential convenience advantage for patients, although the clinical significance of reduced pill burden in this population has not been independently evaluated in the prescribing information.

Enzalutamide's efficacy across its approved indications was demonstrated in 6 randomized, multicenter clinical trials: AFFIRM (NCT00974311) in postchemotherapy metastatic CRPC, PREVAIL (NCT01212991) and TERRAIN (NCT01288911) in chemotherapy-naive metastatic CRPC, PROSPER (NCT02003924) in nonmetastatic CRPC, ARCHES (NCT02677896) in mCSPC, and EMBARK (NCT02319837) in nmCSPC with high-risk biochemical recurrence. Across these trials, enzalutamide demonstrated statistically significant improvements in overall survival, radiographic progression-free survival, or metastasis-free survival vs comparator.

End of Exclusivity

The FDA’s exclusivity period for nmCSPC with biochemical recurrence expires on November 17, 2026, whereas key patents for enzalutamide in nmCSPC, CSPC, and CRPC held by the Regents of the University of California and licensed by Astellas expire on May 15, 2026; August 24, 2026; and August 13, 2027, respectively.³

Several other tentative approvals have been granted for enzalutamide tablets or capsules including for Sandoz and Actavis.^4,5

REFERENCES

1. Lupin Receives Tentative Approval from U.S. FDA for Enzalutamide Tablets. News release. Lupin Limited. June 26, 2026. Accessed June 26, 2026. https://tinyurl.com/yt4bnv6x

2. Xtandi. Prescribing information. Astellas, 2023. Accessed June 26, 2026. https://tinyurl.com/4khk2cab

3.Generic Xtandi Availability. Drugs.com. Updated June 11, 2026. Accessed June 26, 2026. https://tinyurl.com/4ccbs3nr

4. ANDA tentative approval. FDA. August 2, 2022. Accessed June 26, 2026. https://tinyurl.com/48d3sj77

5. ANDA approval. FDA. May 14, 2026. Accessed June 26, 2026. https://tinyurl.com/mpnvrdac