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menotropins (Humegon)

menotropins is an FDA-licensed reference biologic from Organon USA Inc., a subsidiary of Merck & Co., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

1994

Reference approved

Reference product

351(a)BLA 020328

Humegon menotropins

Organon USA Inc., a subsidiary of Merck & Co., Inc.

Approved
Sep 01, 1994
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for menotropins, in chronological order.

  1. Reference approval

    Approval date of the reference menotropins product.

    32 yr 3 mo ago

Frequently asked questions

Are there biosimilars approved for menotropins (Humegon)?

No 351(k) biosimilars or interchangeable biosimilars referencing menotropins are listed in the FDA Purple Book yet.

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