Purple Book reference family · 351(a) biologic
menotropins (Humegon)
menotropins is an FDA-licensed reference biologic from Organon USA Inc., a subsidiary of Merck & Co., Inc..
351(a) biologicBLA 020328 Organon USA Inc., a subsidiary of Merck & Co., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1994
Reference product
Originator biologic
351(a)BLA 020328
Humegon menotropins
Organon USA Inc., a subsidiary of Merck & Co., 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 menotropins product.
32 yr 4 mo ago
menotropins: 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 menotropins.
Related FDA reference tools
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- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.

