Purple Book product · Reference 351(a)

Lantus

insulin glargine

351(a)BLA 21081DiscLicensed Sanofi-Aventis U.S. LLC

View insulin glargine family Open on FDA Purple Book

Apr 20, 2000

Approved

Reference 351(a)

License type

Disc

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 2000. 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 20, 2000
26 yr 7 mo ago
Today

Pharmaceutical detail

Strength

500UNITS/5ML (100UNITS/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Multi-Dose Vial

Center

CDER

License number

1752

Product number

003

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.

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 · Monthly download

Checked Jul 02, 2026

FDA release · June 2026

FDA source FDA source

monthly-downloadMonthly download · Jul 02, 2026

Change history

v2Jul 02, 2026
v1Jul 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 21081, held by Sanofi-Aventis U.S. LLC.

When was Lantus approved by the FDA?

Lantus was approved by the FDA on Apr 20, 2000.

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