pancrelipase (Cotazym)
pancrelipase is an FDA-licensed reference biologic from Organon USA Inc., a subsidiary of Merck & Co., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1996
Reference approved
Reference product
Cotazym pancrelipase
Organon USA Inc., a subsidiary of Merck & Co., Inc.
- Approved
- Dec 09, 1996
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pancrelipase, in chronological order.
Reference approval
Approval date of the reference pancrelipase product.
29 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for pancrelipase (Cotazym)?
No 351(k) biosimilars or interchangeable biosimilars referencing pancrelipase are listed in the FDA Purple Book yet.
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