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BLA

MECASERMIN RINFABATE RECOMBINANT | B021884 | INSMED

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

December 12, 2012(4951 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Dec. 12, 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 21884

351(a) ReferenceVoluntarily RevokedCDERInjection

Proper Name

mecasermin rinfabate

Applicant

Insmed Incorporated

Approval Date

12-Dec-05

Orphan Exclusivity

12-Dec-12

Expired

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 36MG/0.6ML

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2005-12-12 00:00:00

No patent or exclusivity listings for this strength.