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FDA Purple Book · Reference family

choriogonadotropin alfa (Ovidrel)

choriogonadotropin 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

2000

Reference approved

Reference product

351(a)BLA 021149

Ovidrel choriogonadotropin alfa

EMD Serono, Inc.

Approved
Sep 20, 2000
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference choriogonadotropin alfa product.

    26 yr 1 mo ago

Frequently asked questions

Are there biosimilars approved for choriogonadotropin alfa (Ovidrel)?

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

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