alemtuzumab (Campath)
alemtuzumab is an FDA-licensed reference biologic from Genzyme Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2004
Reference approved
Reference product
Campath alemtuzumab
Genzyme Corporation
- Approved
- Oct 12, 2004
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for alemtuzumab, in chronological order.
Reference approval
Approval date of the reference alemtuzumab product.
21 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
18 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for alemtuzumab (Campath)?
No 351(k) biosimilars or interchangeable biosimilars referencing alemtuzumab are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.