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INCRELEX

BLA

MECASERMIN RECOMBINANT | B021839 | IPSEN INC

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

August 30, 2012(5055 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Aug. 30, 2012	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 21839

351(a) ReferenceLicensedCDERInjection

Proper Name

mecasermin

Applicant

Eton Pharmaceuticals, Inc.

Approval Date

30-Aug-05

Orphan Exclusivity

30-Aug-12

Expired

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

Approval Letters

11 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/4ML (10MG/ML)

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2005-08-30 00:00:00

No patent or exclusivity listings for this strength.