Purple Book reference family · 351(a) biologic
belatacept (Nulojix)
belatacept is an FDA-licensed reference biologic from Bristol-Myers Squibb Company.
351(a) biologicBLA 125288 Bristol-Myers Squibb Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2011
Reference product
Originator biologic
351(a)BLA 125288
Nulojix belatacept
Bristol-Myers Squibb Company
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference belatacept product.
15 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
8 yr 5 mo ago
belatacept: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for belatacept.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
