atidarsagene autotemcel (Lenmeldy)
atidarsagene autotemcel is an FDA-licensed reference biologic from Orchard Therapeutics (Europe) Ltd.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
Lenmeldy atidarsagene autotemcel
Orchard Therapeutics (Europe) Ltd.
- Approved
- Mar 18, 2024
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for atidarsagene autotemcel, in chronological order.
First licensure
Date atidarsagene autotemcel was first licensed by the FDA.
2 yr 3 mo ago
Reference approval
Approval date of the reference atidarsagene autotemcel product.
2 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 10 mo
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 9 yr 11 mo
Frequently asked questions
Are there biosimilars approved for atidarsagene autotemcel (Lenmeldy)?
No 351(k) biosimilars or interchangeable biosimilars referencing atidarsagene autotemcel are listed in the FDA Purple Book yet.
When does atidarsagene autotemcel (Lenmeldy) lose reference-product exclusivity?
atidarsagene autotemcel's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending March 18, 2036.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.