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BLA

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM | B125338 | AUXILIUM PHARMS

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

December 6, 2020(2035 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Dec. 6, 2020	Expired	Purple Book

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 125338

351(a) ReferenceLicensedCDERFor Injection

Proper Name

collagenase clostridium histolyticum

Applicant

Auxilium Pharmaceuticals, Inc.

Approval Date

2-Feb-10

Orphan Exclusivity

6-Dec-20

Expired

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

Approval Letters

20 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.9MG

▴

SOLUTION; INJECTION | Approved: 2010-02-02 00:00:00

No patent or exclusivity listings for this strength.