Purple Book reference family · 351(a) biologic
luspatercept-aamt (Reblozyl)
luspatercept-aamt is an FDA-licensed reference biologic from Celgene Corporation, a Bristol-Myers Squibb Company.
351(a) biologicBLA 761136 Celgene Corporation, a Bristol-Myers Squibb Company
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2019
Reference product
Originator biologic
351(a)BLA 761136
Reblozyl luspatercept-aamt
Celgene Corporation, a 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 luspatercept-aamt product.
7 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr
luspatercept-aamt: 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 luspatercept-aamt.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
