Purple Book product · Reference 351(a)

Lenmeldy

atidarsagene autotemcel

351(a)BLA 125758RxLicensed Orchard Therapeutics (Europe) Ltd.

View atidarsagene autotemcel family Label PDF Open on FDA Purple Book

Mar 18, 2024

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Lenmeldy (atidarsagene autotemcel) is Orchard Therapeutics (Europe) Ltd.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2024. No biosimilars referencing Lenmeldy are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Mar 18, 1936.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Mar 18, 1931
96 yr 9 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Mar 18, 1936
91 yr 8 mo ago
First licensure
Date the BLA was first licensed.
Mar 18, 2024
2 yr 4 mo ago
Approval
Approval date of this BLA submission.
Mar 18, 2024
2 yr 4 mo ago
Today

Pharmaceutical detail

Strength

2 x 10^6 to 11.8 x 10^6CELL/ML

Dosage form

Suspension

Route

Intravenous

Presentation

Bag

Center

CBER

License number

2263

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
monthly-downloadMonthly download · Jul 02, 2026

Change history

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

Frequently asked questions

Does Lenmeldy have approved biosimilars?

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

When does Lenmeldy lose reference-product exclusivity?

Lenmeldy's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Mar 18, 1936.

What is Lenmeldy's BLA number?

Lenmeldy is licensed under BLA 125758, held by Orchard Therapeutics (Europe) Ltd..

When was Lenmeldy approved by the FDA?

Lenmeldy was first licensed by the FDA on Mar 18, 2024.

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