FDA Purple Book · Reference family
chymopapain (Chymodiactin)
chymopapain is an FDA-licensed reference biologic from DisCure Medical, LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1982
Reference approved
Reference product
351(a)BLA 018663
Chymodiactin chymopapain
DisCure Medical, LLC
- Approved
- Nov 10, 1982
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for chymopapain, in chronological order.
Reference approval
Approval date of the reference chymopapain product.
44 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for chymopapain (Chymodiactin)?
No 351(k) biosimilars or interchangeable biosimilars referencing chymopapain are listed in the FDA Purple Book yet.
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