Wednesday, July 8, 2026

Drug profile · INN

leuprolide acetate

leuprolide acetate (LUPANETA PACK) is a gonadotropin-releasing hormone receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: implantation. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 20
Pipeline programs 4
News articles 0
Drug details — leuprolide acetate
US status
approved
Class
Route
IMPLANTATION
Patents
20
Programs
4
Data quality
0.89

Quick answer

leuprolide acetate (LUPANETA PACK) is a gonadotropin-releasing hormone receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: implantation. Current US regulatory status: approved.

Key facts

INN leuprolide acetate
Brand LUPANETA PACK
Mechanism Gonadotropin-releasing hormone receptor agonist
Target Gonadotropin-releasing hormone receptor
Route IMPLANTATION
Formulation POWDER

Mechanism of action

Gonadotropin-releasing hormone receptor agonist

Primary target: Gonadotropin-releasing hormone receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Leuprolide acetate Phase 2 · Voyager Therapeutics · Alzheimer Disease
  2. leuprolide Phase 2 · Ultragenyx UK · Hyperandrogenism
  3. leuprolide Phase 2 · Ultragenyx UK · Spinal Muscular Atrophy
  4. leuprolide acetate Phase 2 · Ultragenyx UK · Acanthosis Nigricans

Related & competitor drugs

  1. cetrorelix acetate Gonadotropin-releasing hormone receptor antagonist
  2. elagolix Gonadotropin-releasing hormone receptor antagonist
  3. ganirelix acetate Gonadotropin-releasing hormone receptor antagonist
  4. abarelix Gonadotropin-releasing hormone receptor antagonist
  5. degarelix acetate Gonadotropin-releasing hormone receptor antagonist
  6. elagolix sodium Gonadotropin-releasing hormone receptor antagonist
  1. US 12419969

    AAV capsid variants and uses thereof

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    granted
  2. US 12305189

    Compositions and methods for delivery of AAV

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    granted
  3. US 12296025

    AAV capsid variants and uses thereof

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    granted
  4. US 12291565

    Tau binding compounds

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    granted
  5. US 12281321

    Frataxin expression constructs having engineered promoters and methods of use thereof

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    granted
  6. US 12252703

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    granted
  7. US 12123002

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    granted
  8. US 12084659

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    granted
  9. US 11951121

    Compositions and methods for treating Huntington's disease

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    granted
  10. US 11859200

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    granted
  11. US 11752181

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    granted
  12. US 11603542

    Compositions and methods of treating amyotrophic lateral sclerosis (ALS)

    Expires Mon Mar 09 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 11542506

    Compositions and methods of treating amyotrophic lateral sclerosis (ALS)

    Expires Mon Dec 29 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 11512327

    Compositions and methods for delivery of AAV

    Expires Mon Nov 24 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 11193129

    Modulatory polynucleotides

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    granted
  16. US 11066679

    Closed-ended linear duplex DNA for non-viral gene transfer

    Expires Mon Jul 15 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 10920227

    Compositions and methods of treating amyotrophic lateral sclerosis (ALS)

    Expires Mon Feb 11 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 10597660

    Compositions and methods of treating amyotrophic lateral sclerosis (ALS)

    Expires Mon Mar 19 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 10584337

    Modulatory polynucleotides

    Expires Mon Mar 05 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 9617303

    Sustained-release composition and method for producing the same

    Expires Mon Apr 06 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is leuprolide acetate?

leuprolide acetate (LUPANETA PACK) is a gonadotropin-releasing hormone receptor agonist. Associated with Amneal Pharma Europe Ltd. Route of administration: implantation. Current US regulatory status: approved.

What is the brand name for leuprolide acetate?

LUPANETA PACK is a marketed brand name for leuprolide acetate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of leuprolide acetate?

leuprolide acetate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.