cipaglucosidase alfa-atga (Pombiliti)
cipaglucosidase alfa-atga is an FDA-licensed reference biologic from Amicus Therapeutics US, LLC. 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
Pombiliti cipaglucosidase alfa-atga
Amicus Therapeutics US, LLC
- Approved
- Sep 28, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for cipaglucosidase alfa-atga, in chronological order.
Reference approval
Approval date of the reference cipaglucosidase alfa-atga product.
2 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for cipaglucosidase alfa-atga (Pombiliti)?
No 351(k) biosimilars or interchangeable biosimilars referencing cipaglucosidase alfa-atga are listed in the FDA Purple Book yet.
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