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Purple Book product · Reference 351(a)

Actemra

tocilizumab

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

Nov 19, 2018

Approved

Reference 351(a)

License type

Rx

Marketing

35

Listed patents

Actemra (tocilizumab) is Genentech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2018. The FDA Purple Book lists 35 published patents for it, the last expiring 2035. 3 approved follow-on biologics reference Actemra (Tofidence, Tyenne, and Avtozma).

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

  1. Approval

    Approval date of this BLA submission.

    Nov 19, 2018

    7 yr 9 mo ago

  2. Today

  3. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    Sep 04, 2028

    in 2 yr 2 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. Its approved biosimilars and interchangeables are listed below.

1 additional BLA record for this product (other strengths or presentations) are in the same reference family.

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, 20233 yr agoFDA
10,744,201Apr 28, 20242 yr 3 mo agoFDA
7,521,052Apr 28, 20242 yr 3 mo agoFDA
8,709,409Jun 22, 20242 yr 1 mo agoFDA
8,734,800Mar 24, 20251 yr 4 mo agoFDA
9,902,777May 28, 20251 yr 2 mo agoFDA
8,617,550Mar 03, 20265 mo agoFDA
8,398,980Feb 25, 2028in 1 yr 8 moFDA
11,078,294Jul 08, 2028in 2 yrFDA
8,574,869Jul 08, 2028in 2 yrFDA
11,008,394Dec 26, 2028in 2 yr 6 moFDA
11,359,026Dec 26, 2028in 2 yr 6 moFDA
11,584,798Dec 26, 2028in 2 yr 6 moFDA
11,136,375Jul 19, 2029in 3 yr 1 moFDA
8,568,720Nov 05, 2029in 3 yr 4 moFDA
10,982,003Aug 06, 2030in 4 yr 1 moFDA
9,714,293Aug 06, 2030in 4 yr 1 moFDA
10,501,769Oct 25, 2030in 4 yr 4 moFDA
11,021,728Oct 25, 2030in 4 yr 4 moFDA
11,136,610Oct 25, 2030in 4 yr 4 moFDA
11,377,678Oct 25, 2030in 4 yr 4 moFDA
8,512,983Jan 04, 2031in 4 yr 6 moFDA
10,662,237Aug 07, 2031in 5 yr 2 moFDA
11,667,720Nov 07, 2031in 5 yr 5 moFDA
8,580,264Nov 07, 2031in 5 yr 5 moFDA
10,231,981Dec 03, 2031in 5 yr 5 moFDA
10,874,677Mar 02, 2032in 5 yr 8 moFDA
9,539,263May 23, 2032in 5 yr 11 moFDA
9,750,752Aug 30, 2032in 6 yr 3 moFDA
10,590,164Mar 19, 2033in 6 yr 9 moFDA
9,630,988Jun 13, 2033in 7 yrFDA
10,676,710Mar 14, 2034in 7 yr 9 moFDA
10,829,732Mar 14, 2034in 7 yr 9 moFDA
10,017,732Dec 25, 2034in 8 yr 7 moFDA
10,336,983Jul 31, 2035in 9 yr 2 moFDA

Source provenance

Source kind · Advanced Search
Checked Jul 02, 2026
FDA source FDA source
  • advanced-searchAdvanced Search · Jul 02, 2026
  • monthly-downloadMonthly download · Jul 02, 2026

Change history

  • v4Jul 02, 2026
  • v3Jul 02, 2026
  • v2Jul 02, 2026

Frequently asked questions

When do Actemra's patents expire?

The FDA Purple Book lists 35 published patents for Actemra, with the last listed patent expiring Jul 31, 2035. Every patent below links to its FDA source record so you can verify the expiration date.

Does Actemra have approved biosimilars?

Yes. 3 approved follow-on biologics reference Actemra in the Purple Book: Tofidence, Tyenne, and Avtozma.

What is Actemra's BLA number?

Actemra is licensed under BLA 125472, held by Genentech, Inc..

When was Actemra approved by the FDA?

Actemra was approved by the FDA on Nov 19, 2018.

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