afamitresgene autoleucel (tecelra)
afamitresgene autoleucel is an FDA-licensed reference biologic from USWM CT, LLC. 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
tecelra afamitresgene autoleucel
USWM CT, LLC
- Approved
- Aug 01, 2024
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for afamitresgene autoleucel, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
96 yr 4 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
91 yr 3 mo ago
First licensure
Date afamitresgene autoleucel was first licensed by the FDA.
2 yr ago
Reference approval
Approval date of the reference afamitresgene autoleucel product.
2 yr ago
Frequently asked questions
Are there biosimilars approved for afamitresgene autoleucel (tecelra)?
No 351(k) biosimilars or interchangeable biosimilars referencing afamitresgene autoleucel are listed in the FDA Purple Book yet.
When does afamitresgene autoleucel (tecelra) lose reference-product exclusivity?
afamitresgene autoleucel's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending August 1, 1936.
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.