Wednesday, July 8, 2026

Drug profile · INN

hyaluronidase

hyaluronidase (VITRAGAN) is a hyaluronic acid hydrolytic enzyme. Associated with Amphastar France Pharmaceuticals. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: application withdrawn
US status approved
Patents linked 20
Pipeline programs 13
News articles 0
Drug details — hyaluronidase
US status
approved
Class
Route
INJECTION
Patents
20
Programs
13
Data quality
0.89

Quick answer

hyaluronidase (VITRAGAN) is a hyaluronic acid hydrolytic enzyme. Associated with Amphastar France Pharmaceuticals. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN hyaluronidase
Brand VITRAGAN
Mechanism Hyaluronic acid hydrolytic enzyme
Target Hyaluronic acid
Route INJECTION
Formulation INJECTABLE

Mechanism of action

Hyaluronic acid hydrolytic enzyme

Primary target: Hyaluronic acid

Approval history

Authority Status Date
FDA approved
EMA application withdrawn

Pipeline programs

  1. Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV) Phase 3 · Takeda · Primary Immunodeficiency Diseases (PID)
  2. Hyaluronidase Phase 2 · Amphastar France Pharmaceuticals · Allergic Skin Reaction
  3. Pegvorhyaluronidase alfa Phase 2 · HALOZYME THERAPEUTICS · Pancreatic Ductal Adenocarcinoma
  4. Pembrolizumab (+) Berahyaluronidase alfa Phase 2 · Merck KGaA, Darmstadt · Squamous Cell Carcinoma
  5. Recombinant human hyaluronidase + immune globulin intravenous Phase 2 · Takeda · Primary Immunodeficiency Diseases (PID)
  6. PEGylated recombinant human hyaluronidase PH20 Phase 1 · HALOZYME THERAPEUTICS · Non-small Cell Lung Cancer
  7. Recombinant human hyaluronidase PH20 (rHuPH20) Phase 1 · HALOZYME THERAPEUTICS · Healthy
  8. 1838-009 Approved · HALOZYME THERAPEUTICS · Dehydration

Related & competitor drugs

  1. hyaluronidase recombinant human Hyaluronic acid hydrolytic enzyme
  1. US 12178860

    Hyaluronidase enzyme formulations for high volume administration

    Expires Mon Dec 26 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11723959

    Preparation of mammalian oocyte for fertilization via a soluble human PH20 hyaluronidase polypeptide

    Expires Mon Aug 10 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10898551

    Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof

    Expires Mon Jan 21 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10328130

    Modified hyaluronidases and uses in treating hyaluronan-associated diseases and conditions

    Expires Mon Jun 20 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10286044

    Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof

    Expires Mon May 09 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 9677061

    Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof

    Expires Mon Jun 08 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 9677062

    Hyaluronidase and factor VIII compositions

    Expires Mon Jun 08 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 9562223

    Methods for reducing intraocular pressure by administering a soluble hyaluronidase glycoprotein (sHASEGP)

    Expires Mon Feb 02 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 8772246

    Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof

    Expires Mon Jul 03 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 8765685

    Methods for treating edema by administering a Soluble Hyaluronidase Glycoprotein (sHASEGP)

    Expires Mon Jun 26 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 8450470

    Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof

    Expires Mon May 23 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 8431380

    Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof

    Expires Mon Apr 25 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 8431124

    Methods for treating a disease characterized by an excess of hyaluronan by administering a soluble hyaluronidase glycoprotein (sHASEGP)

    Expires Mon Apr 25 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. CA 2851057

    UTILISATION COMBINEE D'UN GLYCOSAMINOGLYCANE SULFATE ET D'UNE HYALURONIDASE POUR AMELIORER LA BIODISPONIBILITE DU FACTEUR VIII

    Expires Wed Apr 20 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 8202517

    Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof

    Expires Mon Jun 14 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 7781397

    Human plasma hyaluronidase

    Expires Mon Aug 19 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 7767429

    Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof

    Expires Mon Jul 29 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 7148201

    Use of human plasma hyaluronidase in cancer treatment

    Expires Mon Dec 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 7105330

    Human plasma hyaluronidase

    Expires Mon Sep 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 6193963

    Method of treating tumor-bearing patients with human plasma hyaluronidase

    Expires Mon Feb 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is hyaluronidase?

hyaluronidase (VITRAGAN) is a hyaluronic acid hydrolytic enzyme. Associated with Amphastar France Pharmaceuticals. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for hyaluronidase?

VITRAGAN is a marketed brand name for hyaluronidase. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of hyaluronidase?

hyaluronidase 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.