Assyro AI

Purple Book product · Reference 351(a)

Actemra

tocilizumab

351(a)BLA 125472RxLicensed Genentech, Inc.
View tocilizumab familyOpen on FDA Purple Book

At a glance

Nov 19, 2018

Approved

Reference 351(a)

License type

Rx

Marketing

No

Patents listed

Key dates

  1. Approval

    Approval date of this BLA submission.

    Nov 19, 2018

    7 yr 8 mo ago

  2. Today

  3. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    Sep 04, 2028

    in 2 yr 3 mo

Pharmaceutical detail

Strength

162MG/0.9ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

1048

Product number

002

Submission type

Supplement

Supplement number

29

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.

Patent list (35)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
PatentExpiresInSource
7,332,289Aug 04, 20232 yr 11 mo agoFDA
10,744,201Apr 28, 20242 yr 2 mo agoFDA
7,521,052Apr 28, 20242 yr 2 mo agoFDA
8,709,409Jun 22, 20242 yr agoFDA
8,734,800Mar 24, 20251 yr 3 mo agoFDA
9,902,777May 28, 20251 yr agoFDA
8,617,550Mar 03, 20263 mo agoFDA
8,398,980Feb 25, 2028in 1 yr 9 moFDA
11,078,294Jul 08, 2028in 2 yr 2 moFDA
8,574,869Jul 08, 2028in 2 yr 2 moFDA
11,008,394Dec 26, 2028in 2 yr 7 moFDA
11,359,026Dec 26, 2028in 2 yr 7 moFDA
11,584,798Dec 26, 2028in 2 yr 7 moFDA
11,136,375Jul 19, 2029in 3 yr 2 moFDA
8,568,720Nov 05, 2029in 3 yr 6 moFDA
10,982,003Aug 06, 2030in 4 yr 3 moFDA
9,714,293Aug 06, 2030in 4 yr 3 moFDA
10,501,769Oct 25, 2030in 4 yr 5 moFDA
11,021,728Oct 25, 2030in 4 yr 5 moFDA
11,136,610Oct 25, 2030in 4 yr 5 moFDA
11,377,678Oct 25, 2030in 4 yr 5 moFDA
8,512,983Jan 04, 2031in 4 yr 8 moFDA
10,662,237Aug 07, 2031in 5 yr 3 moFDA
11,667,720Nov 07, 2031in 5 yr 6 moFDA
8,580,264Nov 07, 2031in 5 yr 6 moFDA
10,231,981Dec 03, 2031in 5 yr 7 moFDA
10,874,677Mar 02, 2032in 5 yr 10 moFDA
9,539,263May 23, 2032in 6 yr 1 moFDA
9,750,752Aug 30, 2032in 6 yr 4 moFDA
10,590,164Mar 19, 2033in 6 yr 11 moFDA
9,630,988Jun 13, 2033in 7 yr 2 moFDA
10,676,710Mar 14, 2034in 7 yr 11 moFDA
10,829,732Mar 14, 2034in 7 yr 11 moFDA
10,017,732Dec 25, 2034in 8 yr 8 moFDA
10,336,983Jul 31, 2035in 9 yr 3 moFDA

Taxonomy and ontology

12 terms

center

Center for Drug Evaluation and Research

center · CDER

application pathway

Biologics License Application

blaNumber · BLA

license type

351(a)

blaType · 351(a)

application pathway

Section 351(a) Biologic

blaType · 351(a)

product role

Reference or Standalone Biologic

blaType · Reference product

marketing status

Prescription

marketingStatus · Rx

licensure status

Licensed

licensure · Licensed

route

Subcutaneous

routeOfAdministration · Subcutaneous

dosage form

Injection

dosageForm · Injection

source kind

Monthly Download

sourceKind · monthly_download

  • Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
  • Food and Drug Administrationsource forMonthly Download
  • Biologics License Applicationparent ofSection 351(a) Biologic
  • Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
  • Section 351(a) Biologicmaps to351(a)
  • 351(a)classifiesReference or Standalone Biologic

Source provenance

Source kind · Monthly download
Checked May 28, 2026
FDA release · April 2026
FDA source FDA source
Agent CTA Background

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