Purple Book product · Reference 351(a)

Reblozyl

luspatercept-aamt

351(a)BLA 761136RxLicensed Celgene Corporation, a Bristol-Myers Squibb Company

View luspatercept-aamt family Label PDF Open on FDA Purple Book

Nov 08, 2019

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Reblozyl (luspatercept-aamt) is Celgene Corporation, a Bristol-Myers Squibb Company's FDA-licensed reference biologic, approved under a 351(a) BLA in 2019. No biosimilars referencing Reblozyl 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.
Nov 08, 2019
6 yr 9 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Aug 28, 2030
in 4 yr 2 mo

Pharmaceutical detail

Strength

75MG/VIAL

Dosage form

For Injection

Route

Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

2252

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 Reblozyl have approved biosimilars?

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

What is Reblozyl's BLA number?

Reblozyl is licensed under BLA 761136, held by Celgene Corporation, a Bristol-Myers Squibb Company.

When was Reblozyl approved by the FDA?

Reblozyl was approved by the FDA on Nov 08, 2019.

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