alglucosidase alfa (Lumizyme)
alglucosidase alfa 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
2010
Reference approved
Reference product
Lumizyme alglucosidase alfa
Genzyme Corporation
- Approved
- May 24, 2010
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for alglucosidase alfa from the RCSB Protein Data Bank (PDB 5NN6).
Interactive biological assembly from PDB entry 5NN6. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for alglucosidase alfa, in chronological order.
Reference approval
Approval date of the reference alglucosidase alfa product.
16 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for alglucosidase alfa (Lumizyme)?
No 351(k) biosimilars or interchangeable biosimilars referencing alglucosidase alfa are listed in the FDA Purple Book yet.
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.