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BLA

CORTICORELIN OVINE TRIFLUTATE | B020162 | FERRING

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

May 23, 2003(8442 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	May. 23, 2003	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 20162

351(a) ReferenceLicensedCDERFor Injection

Proper Name

corticorelin ovine triflutate

Applicant

Ferring Pharmaceuticals Inc.

Approval Date

23-May-96

Orphan Exclusivity

23-May-03

Expired

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 23, 2020	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.1MG BASE/VIAL

▴

INJECTABLE;INJECTION | Approved: 1996-05-23 00:00:00

No patent or exclusivity listings for this strength.