muromonab-CD3 (Orthoclone OKT3)
muromonab-CD3 is an FDA-licensed reference biologic from Centocor Ortho Biotech Products, L.P.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1992
Reference approved
Reference product
Orthoclone OKT3 muromonab-CD3
Centocor Ortho Biotech Products, L.P.
- Approved
- Sep 14, 1992
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for muromonab-CD3, in chronological order.
Reference approval
Approval date of the reference muromonab-CD3 product.
34 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for muromonab-CD3 (Orthoclone OKT3)?
No 351(k) biosimilars or interchangeable biosimilars referencing muromonab-CD3 are listed in the FDA Purple Book yet.
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