Purple Book product · Reference 351(a)

Adstiladrin

nadofaragene firadenovec-vncg

351(a)BLA 125700RxLicensed Ferring Pharmaceuticals A/S

View nadofaragene firadenovec-vncg family Label PDF Open on FDA Purple Book

Dec 16, 2022

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Adstiladrin (nadofaragene firadenovec-vncg) is Ferring Pharmaceuticals A/S's FDA-licensed reference biologic, approved under a 351(a) BLA in 2022. No biosimilars referencing Adstiladrin are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Dec 16, 1934.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Dec 16, 1934
92 yr 11 mo ago
First licensure
Date the BLA was first licensed.
Dec 16, 2022
3 yr 8 mo ago
Approval
Approval date of this BLA submission.
Dec 16, 2022
3 yr 8 mo ago
Today

Pharmaceutical detail

Strength

3x10^11 viral particles (vp)/mL

Dosage form

For Suspension

Route

Intravesical

Presentation

Single-Dose Vial

Center

CBER

License number

2222

Product number

001

Submission type

Original

Supplement number

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.

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 Adstiladrin have approved biosimilars?

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

When does Adstiladrin lose reference-product exclusivity?

Adstiladrin's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Dec 16, 1934.

What is Adstiladrin's BLA number?

Adstiladrin is licensed under BLA 125700, held by Ferring Pharmaceuticals A/S.

When was Adstiladrin approved by the FDA?

Adstiladrin was first licensed by the FDA on Dec 16, 2022.

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