Purple Book product · Reference 351(a)

Dysport

abobotulinumtoxinA

351(a)BLA 125274RxLicensed Ipsen Biopharm Limited

View abobotulinumtoxinA family Label PDF Open on FDA Purple Book

Apr 29, 2009

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Dysport (abobotulinumtoxinA) is Ipsen Biopharm Limited's FDA-licensed reference biologic, approved under a 351(a) BLA in 2009. No biosimilars referencing Dysport 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.
Apr 29, 2009
17 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jul 29, 2023
3 yr ago
Today

Pharmaceutical detail

Strength

500UNITS

Dosage form

For Injection

Route

Intramuscular

Presentation

Single-Dose Vial

Center

CDER

License number

1787

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 Dysport have approved biosimilars?

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

What is Dysport's BLA number?

Dysport is licensed under BLA 125274, held by Ipsen Biopharm Limited.

When was Dysport approved by the FDA?

Dysport was approved by the FDA on Apr 29, 2009.

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