sotatercept-csrk (Winrevair)
sotatercept-csrk is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
Winrevair sotatercept-csrk
Merck Sharp & Dohme LLC
- Approved
- Mar 26, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for sotatercept-csrk, in chronological order.
Reference approval
Approval date of the reference sotatercept-csrk product.
2 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 11 mo
Frequently asked questions
Are there biosimilars approved for sotatercept-csrk (Winrevair)?
No 351(k) biosimilars or interchangeable biosimilars referencing sotatercept-csrk are listed in the FDA Purple Book yet.
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