Purple Book product · Reference 351(a)

Tysabri

natalizumab

351(a)BLA 125104RxLicensed Biogen Inc.

View natalizumab family Label PDF Open on FDA Purple Book

Nov 23, 2004

Approved

Reference 351(a)

License type

Marketing

Listed patents

Tysabri (natalizumab) is Biogen Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2004. The FDA Purple Book lists 32 published patents for it, the last expiring 2036. 1 approved follow-on biologic reference Tysabri (Tyruko).

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

Key dates

Approval
Approval date of this BLA submission.
Nov 23, 2004
22 yr ago
Today

Pharmaceutical detail

Strength

300MG/15ML (20MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1697

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

TyrukoBiosimilar 351(k)
natalizumab-sztn · Sandoz Inc.
2023

Patent list (32)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
7,157,276	Jun 21, 2024	2 yr 1 mo ago	FDA
7,759,117	Jun 21, 2024	2 yr 1 mo ago	FDA
10,705,095	Apr 04, 2026	4 mo ago	FDA
9,709,575	Apr 04, 2026	4 mo ago	FDA
8,871,449	Apr 12, 2026	3 mo ago	FDA
10,233,245	Feb 28, 2027	in 8 mo	FDA
11,292,845	Feb 28, 2027	in 8 mo	FDA
9,493,567	Mar 05, 2027	in 8 mo	FDA
8,124,350	Aug 02, 2027	in 1 yr 1 mo	FDA
9,696,307	Feb 05, 2030	in 3 yr 7 mo	FDA
9,005,926	Oct 01, 2030	in 4 yr 3 mo	FDA
9,212,379	Nov 28, 2030	in 4 yr 5 mo	FDA
9,096,879	Jan 07, 2031	in 4 yr 6 mo	FDA
10,444,234	Jan 11, 2031	in 4 yr 7 mo	FDA
11,287,423	Jan 11, 2031	in 4 yr 7 mo	FDA
8,318,416	Jan 20, 2031	in 4 yr 7 mo	FDA
10,308,706	Feb 05, 2031	in 4 yr 7 mo	FDA
8,809,049	May 22, 2031	in 4 yr 11 mo	FDA
9,109,015	Aug 13, 2031	in 5 yr 2 mo	FDA
9,316,641	Jan 09, 2032	in 5 yr 7 mo	FDA
10,590,454	May 11, 2032	in 5 yr 11 mo	FDA
9,790,533	May 11, 2032	in 5 yr 11 mo	FDA
9,562,252	May 11, 2033	in 6 yr 11 mo	FDA
10,119,976	May 27, 2034	in 8 yr	FDA
10,677,803	May 27, 2034	in 8 yr	FDA
11,280,794	May 27, 2034	in 8 yr	FDA
10,676,772	Aug 19, 2034	in 8 yr 2 mo	FDA
9,994,968	Aug 19, 2034	in 8 yr 2 mo	FDA
10,023,831	Mar 17, 2035	in 8 yr 9 mo	FDA
11,124,760	Aug 27, 2035	in 9 yr 3 mo	FDA
11,268,119	Feb 21, 2036	in 9 yr 9 mo	FDA
10,844,416	Jun 01, 2036	in 10 yr	FDA

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 Tysabri's patents expire?

The FDA Purple Book lists 32 published patents for Tysabri, with the last listed patent expiring Jun 01, 2036. Every patent below links to its FDA source record so you can verify the expiration date.

Does Tysabri have approved biosimilars?

Yes. 1 approved follow-on biologic reference Tysabri in the Purple Book: Tyruko.

What is Tysabri's BLA number?

Tysabri is licensed under BLA 125104, held by Biogen Inc..

When was Tysabri approved by the FDA?

Tysabri was approved by the FDA on Nov 23, 2004.

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