abatacept (Orencia)
abatacept is an FDA-licensed reference biologic from Bristol-Myers Squibb Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2005
Reference approved
Reference product
Orencia abatacept
Bristol-Myers Squibb Company
- Approved
- Dec 23, 2005
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for abatacept, in chronological order.
Reference approval
Approval date of the reference abatacept product.
20 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 7 mo
Frequently asked questions
Are there biosimilars approved for abatacept (Orencia)?
No 351(k) biosimilars or interchangeable biosimilars referencing abatacept are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.