Purple Book product · Reference 351(a)

Orencia

abatacept

351(a)BLA 125118RxLicensed Bristol-Myers Squibb Company

View abatacept family Label PDF Open on FDA Purple Book

Dec 23, 2005

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Orencia (abatacept) is Bristol-Myers Squibb Company's FDA-licensed reference biologic, approved under a 351(a) BLA in 2005. No biosimilars referencing Orencia 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.
Dec 23, 2005
20 yr 10 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 15, 2028
in 2 yr 5 mo

Pharmaceutical detail

Strength

250MG

Dosage form

For Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1713

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. No biosimilars or interchangeables reference it in the Purple Book yet.

4 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

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 Orencia have approved biosimilars?

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

What is Orencia's BLA number?

Orencia is licensed under BLA 125118, held by Bristol-Myers Squibb Company.

When was Orencia approved by the FDA?

Orencia was approved by the FDA on Dec 23, 2005.

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