follitropin alfa (Gonal-f)
follitropin alfa is an FDA-licensed reference biologic from EMD Serono, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2001
Reference approved
Reference product
Gonal-f follitropin alfa
EMD Serono, Inc.
- Approved
- Feb 28, 2001
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for follitropin alfa, in chronological order.
Reference approval
Approval date of the reference follitropin alfa product.
25 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
19 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for follitropin alfa (Gonal-f)?
No 351(k) biosimilars or interchangeable biosimilars referencing follitropin alfa are listed in the FDA Purple Book yet.
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