thyrotropin alfa (Thyrogen)
thyrotropin alfa is an FDA-licensed reference biologic from Genzyme Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1998
Reference approved
Reference product
Thyrogen thyrotropin alfa
Genzyme Corporation
- Approved
- Nov 30, 1998
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for thyrotropin alfa, in chronological order.
Reference approval
Approval date of the reference thyrotropin alfa product.
27 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
11 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for thyrotropin alfa (Thyrogen)?
No 351(k) biosimilars or interchangeable biosimilars referencing thyrotropin alfa are listed in the FDA Purple Book yet.
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