Purple Book product · Reference 351(a)

ELEVIDYS

delandistrogene moxeparvovec-rokl

351(a)BLA 125781RxLicensed Sarepta Therapeutics, Inc.

View delandistrogene moxeparvovec-rokl family Label PDF Open on FDA Purple Book

Jun 22, 2023

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

ELEVIDYS (delandistrogene moxeparvovec-rokl) is Sarepta Therapeutics, Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2023. No biosimilars referencing ELEVIDYS are listed in the Purple Book yet. Its 12-year reference-product exclusivity under the BPCIA is listed as ending Jun 22, 1935.

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

Key dates

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Jun 20, 1931
96 yr 6 mo ago
Reference product exclusivity ends
12-year reference-product exclusivity window per BPCIA §351(k)(7).
Jun 22, 1935
92 yr 5 mo ago
First licensure
Date the BLA was first licensed.
Jun 22, 2023
3 yr 1 mo ago
Approval
Approval date of this BLA submission.
Jun 22, 2023
3 yr 1 mo ago
Today

Pharmaceutical detail

Strength

1.33 Ã—10E14 vector genomes (vg)/kg/bodyweight(bw)

Dosage form

Suspension

Route

Intravenous

Presentation

Single-Dose Vial

Center

CBER

License number

2308

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 ELEVIDYS have approved biosimilars?

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

When does ELEVIDYS lose reference-product exclusivity?

ELEVIDYS's 12-year reference-product exclusivity under the BPCIA is listed in the Purple Book as ending Jun 22, 1935.

What is ELEVIDYS's BLA number?

ELEVIDYS is licensed under BLA 125781, held by Sarepta Therapeutics, Inc..

When was ELEVIDYS approved by the FDA?

ELEVIDYS was first licensed by the FDA on Jun 22, 2023.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo