Purple Book product · Reference 351(a)

Lantus

insulin glargine

351(a)BLA 021081RxLicensed Sanofi-Aventis U.S. LLC

View insulin glargine family Label PDF Open on FDA Purple Book

Apr 25, 2007

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Lantus (insulin glargine) is Sanofi-Aventis U.S. LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2007. 3 approved follow-on biologics reference Lantus (Semglee, Rezvoglar, and Langlara).

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

Key dates

Approval
Approval date of this BLA submission.
Apr 25, 2007
19 yr 6 mo ago
Today

Pharmaceutical detail

Strength

300UNITS/3ML (100UNITS/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

1752

Product number

002

Submission type

Supplement

Supplement number

Change type

Not listed

Reference product family

View full family

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

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

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

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Change history

v2Jul 02, 2026

Frequently asked questions

Does Lantus have approved biosimilars?

Yes. 3 approved follow-on biologics reference Lantus in the Purple Book: Semglee, Rezvoglar, and Langlara.

What is Lantus's BLA number?

Lantus is licensed under BLA 021081, held by Sanofi-Aventis U.S. LLC.

When was Lantus approved by the FDA?

Lantus was approved by the FDA on Apr 25, 2007.

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