LEUPROLIDE ACETATE | N205054 | INVAGEN PHARMACEUTICALS INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Active | M.D. Anderson Cancer Center | 310 | 2013-02-05 → 2027-02-01 | |
| Phase 3 | Active | Pfizer | 1,068 | 2014-12-17 → 2026-09-19 | |
| Phase 2 | Active | Rana McKay, MD | 32 | 2023-02-01 → 2026-12 | |
| Phase 2/3 | Active | NRG Oncology | 612 | 2017-04-05 → 2030-10-31 | |
| Phase 2 | Active | Jonsson Comprehensive Cancer Center | 28 | 2021-03-17 → 2028-01-01 | |
| Phase 2 | Active | Mark Stein | 26 | 2019-05-16 → 2028-04 | |
| Phase 3 | Active | NRG Oncology | 2,753 | 2021-01-21 → 2038-12-31 | |
| Phase 2/3 | Active | VA Office of Research and Development | 378 | 2021-07-01 → 2029-03-30 | |
| Phase 3 | Active | UNICANCER | 490 | 2020-01-09 → 2033-12-28 | |
| Phase 2 | Active | City of Hope Medical Center | 25 | 2018-08-29 → 2027-01-06 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$231.63
Highest Price
$238.60
FSS NDCs
2
Big4 NDCs
0
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 69097-0909-50LEUPROLIDE ACETATE 22.5MG (3 MONTH) INJ,SUSP, | $231.63 | FSS | Cipla USA, Inc. | 08/14/2026 |
| 83831-0134-01LUTRATE DEPOT 22.5MG | $238.60 | FSS | Avyxa Pharma, LLC | 05/14/2030 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
15 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Nov 15, 2024 | SUPPL -7 | View Letter (PDF) |
| Aug 9, 2024 | SUPPL -6 | View Letter (PDF) |
| Dec 1, 2023 | SUPPL -5 | View Letter (PDF) |
| Mar 1, 2023 | SUPPL -4 | View Letter (PDF) |
| Sep 18, 2018 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.