Prescription medicine
Leuprolide Brand names: Lupron, Eligard, Camcevi, Fensolvi, Lutrate
Leuprolide (Lupron) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $197.61 per unit (Leuprolide 2wk 14 mg/2.8 mL kt) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $2,174.17 per unit (Lupron depot 7.5 mg 1 month kt).
- Generic listed
Check it at the source: the leuprolide FDA label on DailyMed (effective May 28, 2026, Amneal Pharmaceuticals LLC); the NDA 19010 record on Drugs@FDA; every leuprolide label on DailyMed.
Highlights of the record
FDA label of May 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLeuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
Forms and strengths
- 1 mg/.2ml
- 7.5 mg/.25ml
- 22.5 mg/.375ml
- 30 mg/.5ml
- 42 mg/.37g
- 45 mg/.375ml
Kit; extended-release injection (suspension); injection (emulsion); injection.
On the market
- Earliest approval on file
- April 9, 1985 Lupron, Abbvie Endocrine Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first August 4, 1998; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 12 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- February 5, 2031 Lupron Depot-Ped Kit injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $197.61 per unit Leuprolide 2wk 14 mg/2.8 mL kt
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2014 0 Class I among all firms' recalls; latest September 12, 2023; 1 more by firms not listed as its makers
- FAERS reports
- 78,546 through July 30, 2026
What is leuprolide used for?
From the label: indications and usageLeuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
Conditions named in the indications of leuprolide's FDA labels, with every medicine labeled for each:
From other leuprolide labelsProstate cancer: LUTRATE DEPOT 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced prostate cancer.
Anemia: Leiomyomata (Fibroids) LUPRON DEPOT 3.75 mg, used concomitantly with iron therapy, is indicated for the preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed …
FDA pharmacologic class: Gonadotropin Releasing Hormone Receptor Agonist.
Source: FDA drug label (leuprolide acetate), Amneal Pharmaceuticals LLC, effective May 28, 2026 (SPL set 4838c674-044e-46b2-81e7-c691b99d8fa5), via openFDA; the full label on DailyMed
What does the patient leaflet for leuprolide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LUPRON DEPOT-PED?During the first 2 to 4 weeks of treatment, LUPRON DEPOT-PED can cause an increase in some hormones. During this time you may notice more signs of puberty in your child, including vaginal bleeding. Call your doctor if these signs continue after the second month of treatment with LUPRON DEPOT-PED. Some people taking gonadotropin releasing hormone (GnRH) agonists like LUPRON DEPOT-PED have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: ◦ crying ◦ irritability ◦ restlessness (impatience) ◦ anger ◦ acting aggressive Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems while taking LUPRON DEPOT-PED. Some people taking GnRH agonists like LUPRON DEPOT-PED have had seizures. The risk of seizures may be higher in people who: ◦ have a history of seizures ◦ have a history of epilepsy ◦ have a history of brain or brain vessel (cerebrovascular) problems or tumors ◦ are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs) Seizures have also happened in people who have not had any of these problems. Call your child’s doctor right away if your child has a seizure while taking LUPRON DEPOT-PED . Severe cutaneous (skin) adverse reactions may happen during treatment with GnRH agonists like LUPRON DEPOT-PED . […]
From the patient leaflet: How should I store LUPRON DEPOT-PED INJECTION?Store LUPRON DEPOT-PED INJECTION at room temperature between 68 ○ F to 77 ○ F (20 ○ C to 25 ○ C). Keep LUPRON DEPOT-PED INJECTION and all medicines out of the reach of children.
Source: FDA drug label (Lupron Depot-PED), AbbVie Inc., effective November 14, 2025 (SPL set e99f47d2-da10-3127-ecb3-e5d942ae6e81), via openFDA; the full label on DailyMed
Is there a generic for leuprolide (Lupron)?
The FDA approved the first generic leuprolide on August 4, 1998. 10 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists leuprolide from 12 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Lupron Depot-Ped Kit injection, the last expiring on February 5, 2031; a patent listed only for Fensolvi Kit injection runs to December 22, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1985 earliest approval on file
- 1998 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for leuprolide (Lupron)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $197.61 per unit (Leuprolide 2wk 14 mg/2.8 mL kt), down 18% from $241.44 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Leuprolide 2wk 14 mg/2.8 mL kt (generic)
- Lupron depot 7.5 mg 1 month kt (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Leuprolide 2wk 14 mg/2.8 mL kt | Generic | $197.61 per unit | n/a | -18% |
| Lupron depot 11.25 mg 3mo kit | Brand | $5,437.40 per kit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +4% |
| Lupron depot 3.75 mg kit | Brand | $1,822.08 per kit | n/a | +5% |
| Lupron depot 7.5 mg 1 month kt | Brand | $2,174.17 per unit | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has leuprolide been recalled?
The FDA's Enforcement Report lists 7 recalls naming leuprolide since 2014: 0 Class I (the most serious), 6 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of leuprolide and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 12, 2023 | Class III | Tolmar, Inc. | Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. |
| November 7, 2014 | Class II | Perry Drug Inc. not a listed maker | Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with … |
| March 10, 2014 | Class II | AbbVie Inc | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. |
| March 10, 2014 | Class II | AbbVie Inc | Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the leuprolide label say about other medicines?
The leuprolide label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name leuprolide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bupropion | warnings and precautions | These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. |
| Testosterone | warnings | WARNINGS Initially, leuprolide acetate injection, like other LH-RH agonists, causes increases in serum levels of testosterone. |
Source: FDA drug label (leuprolide acetate), Amneal Pharmaceuticals LLC, effective May 28, 2026 (SPL set 4838c674-044e-46b2-81e7-c691b99d8fa5), via openFDA; the full label on DailyMed
What do FAERS reports show for leuprolide?
The FDA Adverse Event Reporting System holds 78,546 reports that list leuprolide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12,172 are coded as a death and 12,255 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other gonadotropin releasing hormone receptor agonists
- the pharmacologic class, with prices and generics
- Leuprolide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other