Viewing data from:

Lantidra

BLA

donislecel-jujn | B125734 | CellTrans Inc.

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 28, 2035(3282 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 28, 2035	Active	Computed

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 125734

351(a) ReferenceLicensedCBERSuspension

Proper Name

donislecel-jujn

Applicant

CellTrans Inc.

Approval Date

28-Jun-23

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

Products (1)

#1 — 1X10E6EQUIVALENT ISLET NUMBER (EIN)

0 patents0 exclusivities▴

Suspension; Intravenous | Approved: 28-Jun-23

No patent or exclusivity listings for this strength.