Purple Book reference family · 351(a) biologic
urofollitropin (Bravelle)
urofollitropin is an FDA-licensed reference biologic from Ferring Pharmaceuticals Inc..
351(a) biologicBLA 021289 Ferring Pharmaceuticals Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2002
Reference product
Originator biologic
351(a)BLA 021289
Bravelle urofollitropin
Ferring Pharmaceuticals Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference urofollitropin product.
24 yr 7 mo ago
urofollitropin: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for urofollitropin.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

