Purple Book product · Reference 351(a)

Leukine

sargramostim

351(a)BLA 103362DiscLicensed Partner Therapeutics, Inc.

View sargramostim family Label PDF Open on FDA Purple Book

Mar 05, 1991

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Leukine (sargramostim) is Partner Therapeutics, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 1991. No biosimilars referencing Leukine 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.
Mar 05, 1991
35 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 29, 2025
1 yr 4 mo ago
Today

Pharmaceutical detail

Strength

500MCG/ML

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Multi-Dose Vial

Center

CDER

License number

2087

Product number

002

Submission type

Original

Supplement number

Not listed

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.

1 additional BLA record 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

advanced-searchAdvanced Search · Jul 02, 2026
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Change history

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

Frequently asked questions

Does Leukine have approved biosimilars?

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

What is Leukine's BLA number?

Leukine is licensed under BLA 103362, held by Partner Therapeutics, Inc..

When was Leukine approved by the FDA?

Leukine was approved by the FDA on Mar 05, 1991.

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