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ZENPEP

BLA

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | B022210 | EURAND PHARMA LTD

8 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

June 15, 2023(1114 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 15, 2023	Expired	Computed

Purple Book Patents

No listed patents in Purple Book.

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 22210 | 8 presentations

351(a) ReferenceLicensedCDERCapsule, Delayed Release

Proper Name

pancrelipase

Applicant

Zenpep, LLC

Approval Date

27-Aug-09

5,000USP UNITS; 17,000USP UNITS; 24,000USP UNITS (Oral)

10,000USP UNITS; 32,000USP UNITS; 42,000USP UNITS (Oral)

15,000USP UNITS; 47,000USP UNITS; 63,000USP UNITS (Oral)

20,000USP UNITS; 63,000USP UNITS; 84,000USP UNITS (Oral)

3,000USP UNITS; 10,000USP UNITS; 14,000USP UNITS (Oral)

25,000USP UNITS; 79,000USP UNITS; 105,000USP UNITS (Oral)

40,000USP UNITS; 126,000USP UNITS; 168,000USP UNITS (Oral)

60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS (Oral)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.