FDA Purple Book · Reference family
urofollitropin (Bravelle)
urofollitropin is an FDA-licensed reference biologic from Ferring Pharmaceuticals Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2002
Reference approved
Reference product
351(a)BLA 021289
Bravelle urofollitropin
Ferring Pharmaceuticals Inc.
- Approved
- May 06, 2002
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for urofollitropin, in chronological order.
Reference approval
Approval date of the reference urofollitropin product.
24 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for urofollitropin (Bravelle)?
No 351(k) biosimilars or interchangeable biosimilars referencing urofollitropin are listed in the FDA Purple Book yet.
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