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BLA

CENEGERMIN-BKBJ | B761094 | DOMPE FARMACEUTICI

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 22, 2030(1511 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 22, 2030	Active	Computed
7-Year Orphan	Aug. 22, 2025	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 761094

351(a) ReferenceLicensedCDERSolution

Proper Name

cenegermin-bkbj

Applicant

Dompé farmaceutici S.p.A.

Approval Date

22-Aug-18

Orphan Exclusivity

22-Aug-25

Expired

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.002%(20MCG/ML)

▴

SOLUTION;OPHTHALMIC | Approved: 2018-08-22 00:00:00

No patent or exclusivity listings for this strength.