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BLA

PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | B022175 | DIGESTIVE CARE INC

4 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

May 17, 2024(777 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 17, 2024	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 22175 | 4 presentations

351(a) ReferenceLicensedCDERCapsule, Delayed Release

Proper Name

pancrelipase

Applicant

Digestive Care, Inc.

Approval Date

17-May-12

Presentations

8,000USP UNITS; 28,750USP UNITS; 30,250USP UNITS (Oral)

16,000USP UNITS; 57,500USP UNITS; 60,500USP UNITS (Oral)

4,000USP UNITS; 14,375USP UNITS; 15,125USP UNITS (Oral)

24,000USP UNITS; 86,250USP UNITS; 90,750USP UNITS (Oral)

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 29, 2024	SUPPL -10	View Letter (PDF)
Sep 29, 2022	SUPPL -8	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 30,250USP UNITS;8,000USP UNITS;28,750USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2012-05-17 00:00:00

No patent or exclusivity listings for this strength.

#002 — 60,500USP UNITS;16,000USP UNITS;57,500USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2012-05-17 00:00:00

#003 — 15,125USP UNITS;4,000USP UNITS;14,375USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2012-05-17 00:00:00

#004 — 90,750USP UNITS;24,000USP UNITS;86,250USP UNITS

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CAPSULE, DELAYED RELEASE;ORAL | Approved: 2012-05-17 00:00:00