Purple Book product · Reference 351(a)

Simponi

golimumab

351(a)BLA 125289RxLicensed Janssen Biotech, Inc.

View golimumab family Label PDF Open on FDA Purple Book

May 15, 2013

Approved

Reference 351(a)

License type

Marketing

Listed patents

Simponi (golimumab) is Janssen Biotech, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2013. The FDA Purple Book lists 26 published patents for it, the last expiring 2039. No biosimilars referencing Simponi are listed in the Purple Book yet.

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

Key dates

Approval
Approval date of this BLA submission.
May 15, 2013
13 yr 4 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Oct 07, 2032
in 6 yr 4 mo

Pharmaceutical detail

Strength

100MG/ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

1864

Product number

003

Submission type

Supplement

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

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

Patent list (26)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
8,017,325	Jan 13, 2029	in 2 yr 6 mo	FDA
8,017,325	Jan 13, 2029	in 2 yr 6 mo	FDA
10,500,348	Nov 20, 2031	in 5 yr 5 mo	FDA
9,170,249	Mar 12, 2032	in 5 yr 9 mo	FDA
9,170,249	Mar 12, 2032	in 5 yr 9 mo	FDA
9,890,410	Mar 12, 2032	in 5 yr 9 mo	FDA
9,890,410	Mar 12, 2032	in 5 yr 9 mo	FDA
12,139,735	Jul 06, 2032	in 6 yr 1 mo	FDA
12,139,735	Jul 06, 2032	in 6 yr 1 mo	FDA
8,852,889	Jul 06, 2032	in 6 yr 1 mo	FDA
8,852,889	Jul 06, 2032	in 6 yr 1 mo	FDA
9,475,858	Jul 06, 2032	in 6 yr 1 mo	FDA
9,475,858	Jul 06, 2032	in 6 yr 1 mo	FDA
11,633,546	Nov 08, 2032	in 6 yr 5 mo	FDA
8,956,830	Mar 14, 2033	in 6 yr 9 mo	FDA
8,956,830	Mar 14, 2033	in 6 yr 9 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 9 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 9 mo	FDA
9,487,810	Mar 14, 2033	in 6 yr 9 mo	FDA
9,487,810	Mar 14, 2033	in 6 yr 9 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 9 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 9 mo	FDA
10,421,986	Aug 08, 2035	in 9 yr 2 mo	FDA
10,421,986	Aug 08, 2035	in 9 yr 2 mo	FDA
11,225,516	May 03, 2039	in 13 yr	FDA
11,225,516	May 03, 2039	in 13 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 Simponi's patents expire?

The FDA Purple Book lists 26 published patents for Simponi, with the last listed patent expiring May 03, 2039. Every patent below links to its FDA source record so you can verify the expiration date.

Does Simponi have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Simponi are listed in the FDA Purple Book yet.

What is Simponi's BLA number?

Simponi is licensed under BLA 125289, held by Janssen Biotech, Inc..

When was Simponi approved by the FDA?

Simponi was approved by the FDA on May 15, 2013.

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