Tools / Drug approvals and letters / Drugs Leuprolide Acetate Treats advanced prostate cancer. Sold as Lupron, Lupron Depot, Lupron Depot-Ped, Viadur, Eligard and 3 more. Every FDA application for this active ingredient: 15 branded and 10 generic.
As of Nov 15, 2026, FDA lists 25 applications for Leuprolide Acetate (sold as Lupron, Lupron Depot, Lupron Depot-Ped and others), first approved Apr 9, 1985, with 21 new uses approved and 1 published complete response letter.
First approved : Apr 9, 1985 Applications : 25 New uses approved : 21 Complete response letters : 1 Medicare spending, 2025 : $503M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Lupron Depot Part D $276M +68% 17,362 Eligard Part B $193M -10% 134,521 Eligard Part D $18.7M +53% 5,901 Lupron Depot Part B $13.9M +24% 1,241 Lupron Depot-Ped Part D $485K -7% 18 Leuprolide Depot Part B $337K -84% 193 Leuprolide Depot Part D $43K -79% 26 Leuprolide Acetate Part D $41K +189% 15
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change LEUPROLIDE 2WK 14 MG/2.8 ML KT: $197.61 per unit Generic · -18% in a year LUPRON DEPOT 11.25 MG 3MO KIT: $5441.50 per unit Brand · +5% in a year LUPRON DEPOT 3.75 MG KIT: $1820.80 per unit Brand · +5% in a year LUPRON DEPOT 7.5 MG 1 MONTH KT: $2174.20 per unit Brand · new this year Clinical Trials 120 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Intra-ovarian CAPA-IVM vs Standard IVM Infertility (IVF Patients), Infertility · New Hope Fertility Center Not applicable Not yet recruiting Oct 5, 2026 Autonomic and Renal Contributions to Hypertension With ADT Androgen Deprivation Therapy, Prostate Cancer · Virginia Commonwealth University Phase 4 Recruiting Sep 30, 2026 Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer Invasive Breast Cancer (Stage I-III) · The Second Hospital of Anhui Medical University Phase 2 Not yet recruiting Sep 3, 2026 Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer Prostate Cancer · NYU Langone Health Phase 2 Recruiting Sep 3, 2026 QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy Breast Cancer · Hebei Medical University Fourth Hospital Phase 2 Not yet recruiting Aug 24, 2026 Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis Endometriosis · Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. Phase 1 Recruiting Aug 10, 2026 Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer Prostate Cancer, mHSPC · University College, London Phase 3 Recruiting Aug 7, 2026 Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer. Prostate Cancer, Prostate · RenJi Hospital Phase 2 Not yet recruiting Jul 28, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Apr 9, 1985 Lupron NDA 19010 · New molecular entity 34 Discontinued Jan 26, 1989 Lupron Depot NDA 19732 · New dosage form 38 Marketed Oct 22, 1990 Lupron Depot NDA 20011 · New dosage form 36 Marketed Apr 16, 1993 Lupron Depot-Ped NDA 20263 · New formulation or manufacturer 40 Marketed Mar 30, 1995 Lupron Depot NDA 19943 · New formulation or manufacturer 31 Marketed Dec 22, 1995 Lupron Depot NDA 20517 · New dosage form 35 Marketed Mar 7, 1997 Lupron Depot NDA 20708 · New dosage form 30 Marketed Aug 4, 1998 Leuprolide Acetate ANDA 74728 14 Marketed Mar 3, 2000 Viadur NDA 21088 · New dosage form 17 Discontinued Oct 25, 2000 Leuprolide Acetate ANDA 75471 12 Marketed Nov 29, 2001 Leuprolide Acetate ANDA 75721 0 Discontinued Jan 23, 2002 Eligard NDA 21343 · New dosage form 24 Marketed Jul 24, 2002 Eligard NDA 21379 · New dosage form 21 Marketed Feb 13, 2003 Eligard NDA 21488 · New dosage form 16 Marketed Dec 14, 2004 Eligard NDA 21731 · New dosage form 19 Marketed Mar 9, 2009 Leuprolide Acetate ANDA 78885 10 Marketed Aug 28, 2018 Leuprolide Acetate For Depot Suspension NDA 205054 · New formulation or manufacturer 4 Marketed May 1, 2020 Fensolvi NDA 213150 · New indication 5 Marketed Aug 13, 2021 Leuprolide Acetate ANDA 213829 3 Marketed Jun 6, 2022 Leuprolide Acetate ANDA 212963 3 Marketed Oct 28, 2022 Leuprolide Acetate ANDA 215336 3 Marketed Oct 17, 2024 Leuprolide Acetate ANDA 217957 3 Marketed Jun 9, 2025 Leuprolide Acetate ANDA 217437 1 Discontinued Nov 13, 2025 Leuprolide Acetate ANDA 215826 1 Marketed Aug 26, 2026 Vobrig NDA 213225 · New formulation or manufacturer 0 Discontinued
Complete Response Letters FDA's published letters for these applications Letter Product Now May 29, 2015 NDA 205054 Clinical/Statistical, Product Quality, Facility Inspections Approved
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sandoz
Eugia Pharma
Zydus Pharms