FDA Purple Book · Reference family
tesamorelin (Egrifta)
tesamorelin is an FDA-licensed reference biologic from Theratechnologies Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2010
Reference approved
Reference product
351(a)BLA 022505
Egrifta tesamorelin
Theratechnologies Inc.
- Approved
- Nov 10, 2010
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tesamorelin, in chronological order.
Reference approval
Approval date of the reference tesamorelin product.
15 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for tesamorelin (Egrifta)?
No 351(k) biosimilars or interchangeable biosimilars referencing tesamorelin are listed in the FDA Purple Book yet.
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