follitropin beta (Follistim)
follitropin beta 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.
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Biosimilars
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Interchangeables
0
Listed patents
1997
Reference approved
Reference product
Follistim follitropin beta
Organon USA Inc., a subsidiary of Merck & Co., Inc.
- Approved
- Sep 29, 1997
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for follitropin beta, in chronological order.
Reference approval
Approval date of the reference follitropin beta product.
29 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for follitropin beta (Follistim)?
No 351(k) biosimilars or interchangeable biosimilars referencing follitropin beta are listed in the FDA Purple Book yet.
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