Purple Book reference family · 351(a) biologic
pancrelipase (Cotazym)
pancrelipase is an FDA-licensed reference biologic from Organon USA Inc., a subsidiary of Merck & Co., Inc..
351(a) biologicBLA 020580 Organon USA Inc., a subsidiary of Merck & Co., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1996
Reference product
Originator biologic
351(a)BLA 020580
Cotazym pancrelipase
Organon USA Inc., a subsidiary of Merck & Co., Inc.
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference pancrelipase product.
30 yr 1 mo ago
pancrelipase: 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 pancrelipase.
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