luspatercept-aamt (Reblozyl)
luspatercept-aamt is an FDA-licensed reference biologic from Celgene Corporation, a Bristol-Myers Squibb Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2019
Reference approved
Reference product
Reblozyl luspatercept-aamt
Celgene Corporation, a Bristol-Myers Squibb Company
- Approved
- Nov 08, 2019
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for luspatercept-aamt, in chronological order.
Reference approval
Approval date of the reference luspatercept-aamt product.
6 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 4 mo
Frequently asked questions
Are there biosimilars approved for luspatercept-aamt (Reblozyl)?
No 351(k) biosimilars or interchangeable biosimilars referencing luspatercept-aamt are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.