drug · protein
LEUPROLIDE ACETATE
Marketedupdated 3mo agoby $AMRX Amneal Pharmaceuticals, Inc.🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 7- tagApproval408 co-mentions · 123 sources
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- drugleuprolide acetate SR204 co-mentions · 123 sources
- tagEndocrinology & Metabolism150 co-mentions · 75 sources
Protein drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 20 investigational indications.
indications
investigational
Prostate Cancer
targets
Gonadotropin-releasing hormone receptor
all catalysts(37)
approval · 37
Aug 4, 1998
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Nov 18, 1998
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Oct 25, 2000
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Apr 3, 2001
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Sep 20, 2001
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Sep 13, 2006
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Jul 6, 2008
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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May 27, 2009
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Mar 28, 2011
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Mar 28, 2011
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Sep 27, 2011
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Aug 9, 2012
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Jan 31, 2013
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Nov 17, 2015
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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May 19, 2017
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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May 19, 2017
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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May 19, 2017
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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May 19, 2017
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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May 19, 2017
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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May 1, 2020
approval
FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approval
LEUPROLIDE ACETATE
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Feb 1, 2021
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Feb 1, 2021
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Aug 13, 2021
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
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Apr 22, 2022
approval
FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approval
LEUPROLIDE ACETATE
→
Oct 28, 2022
approval
$AMRX18.15+5.10%
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Nov 25, 2022
approval
FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approval
LEUPROLIDE ACETATE
→
Oct 17, 2024
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Oct 17, 2024
approval
FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approval
LEUPROLIDE ACETATE
→
May 5, 2025
approval
FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approval
LEUPROLIDE ACETATE
→
Sep 19, 2025
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Sep 19, 2025
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Sep 23, 2025
approval
FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approval
LEUPROLIDE ACETATE
→
Sep 23, 2025
approval
$AMRX18.15+5.10%
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Sep 23, 2025
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Sep 23, 2025
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Sep 23, 2025
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Sep 23, 2025
approval
LEUPROLIDE ACETATE — FDA approval
LEUPROLIDE ACETATE
→
Trials studying LEUPROLIDE ACETATE
- phase2A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
- phase1Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer
- phase2Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer
- phase2Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT
- phase1Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer
- phase2Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
- phase3Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
- phase2Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 22, 2028
~1.6 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (19)
- Dec 22, 2041compositionUS 11771841
- Dec 22, 2041compositionUS 11771841
- Dec 22, 2041compositionUS 11771841
- Dec 22, 2041compositionUS 11771841
- Dec 22, 2041compositionUS 11771841
- Dec 22, 2041compositionUS 11931559
- Dec 22, 2041compositionUS 11931559
- Dec 22, 2041compositionUS 11931559
- Dec 22, 2041compositionUS 11931559
- Dec 22, 2041compositionUS 11931559
- Dec 22, 2041method-of-use (U-3611)US 12397120
- Dec 22, 2041method-of-use (U-4001)US 12397120
- Dec 22, 2041method-of-use (U-4001)US 12397120
- Dec 22, 2041method-of-use (U-4001)US 12397120
- Dec 22, 2041method-of-use (U-4001)US 12397120
- Feb 5, 2031formulationUS 89213264.5y
- Feb 5, 2031formulationUS 89213264.5y
- Mar 22, 2028method-of-use (U-4001)US 96173031.6y
- Mar 22, 2028method-of-use (U-3611)US 96173031.6y
FDA exclusivities (1)
- Apr 14, 2026NSNS
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