FDA Purple Book · Reference family
becaplermin (Regranex)
becaplermin is an FDA-licensed reference biologic from Lynch Regenerative Medicine, LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1997
Reference approved
Reference product
351(a)BLA 103691
Regranex becaplermin
Lynch Regenerative Medicine, LLC
- Approved
- Dec 16, 1997
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for becaplermin, in chronological order.
Reference approval
Approval date of the reference becaplermin product.
28 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for becaplermin (Regranex)?
No 351(k) biosimilars or interchangeable biosimilars referencing becaplermin are listed in the FDA Purple Book yet.
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