pegvisomant (Somavert)
pegvisomant is an FDA-licensed reference biologic from Pharmacia & Upjohn Company LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2003
Reference approved
Reference product
Somavert pegvisomant
Pharmacia & Upjohn Company LLC
- Approved
- Mar 25, 2003
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pegvisomant, in chronological order.
Reference approval
Approval date of the reference pegvisomant product.
23 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
16 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for pegvisomant (Somavert)?
No 351(k) biosimilars or interchangeable biosimilars referencing pegvisomant are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.