olipudase alfa-rpcp (Xenpozyme)
olipudase alfa-rpcp 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
2023
Reference approved
Reference product
Xenpozyme olipudase alfa-rpcp
Genzyme Corporation
- Approved
- Mar 31, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for olipudase alfa-rpcp, in chronological order.
Reference approval
Approval date of the reference olipudase alfa-rpcp product.
3 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 4 mo
Frequently asked questions
Are there biosimilars approved for olipudase alfa-rpcp (Xenpozyme)?
No 351(k) biosimilars or interchangeable biosimilars referencing olipudase alfa-rpcp 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.