delandistrogene moxeparvovec-rokl (ELEVIDYS)
delandistrogene moxeparvovec-rokl is an FDA-licensed reference biologic from Sarepta Therapeutics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
ELEVIDYS delandistrogene moxeparvovec-rokl
Sarepta Therapeutics, Inc.
- Approved
- Jun 22, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for delandistrogene moxeparvovec-rokl, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
96 yr 6 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
92 yr 5 mo ago
First licensure
Date delandistrogene moxeparvovec-rokl was first licensed by the FDA.
3 yr 1 mo ago
Reference approval
Approval date of the reference delandistrogene moxeparvovec-rokl product.
3 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for delandistrogene moxeparvovec-rokl (ELEVIDYS)?
No 351(k) biosimilars or interchangeable biosimilars referencing delandistrogene moxeparvovec-rokl are listed in the FDA Purple Book yet.
When does delandistrogene moxeparvovec-rokl (ELEVIDYS) lose reference-product exclusivity?
delandistrogene moxeparvovec-rokl's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending June 22, 1935.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.