etranacogene dezaparvovec-drlb (Hemgenix)
etranacogene dezaparvovec-drlb is an FDA-licensed reference biologic from CSL Behring LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2022
Reference approved
Reference product
Hemgenix etranacogene dezaparvovec-drlb
CSL Behring LLC
- Approved
- Nov 22, 2022
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for etranacogene dezaparvovec-drlb, in chronological order.
First licensure
Date etranacogene dezaparvovec-drlb was first licensed by the FDA.
3 yr 7 mo ago
Reference approval
Approval date of the reference etranacogene dezaparvovec-drlb product.
3 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 6 mo
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 8 yr 7 mo
Frequently asked questions
Are there biosimilars approved for etranacogene dezaparvovec-drlb (Hemgenix)?
No 351(k) biosimilars or interchangeable biosimilars referencing etranacogene dezaparvovec-drlb are listed in the FDA Purple Book yet.
When does etranacogene dezaparvovec-drlb (Hemgenix) lose reference-product exclusivity?
etranacogene dezaparvovec-drlb's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending November 22, 2034.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.