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BLA

DENILEUKIN DIFTITOX-CXDL | B761312 | CITIUS PHARMS

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 7, 2036(3688 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 7, 2036	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 27, 20405169 days remaining

Based on latest discovered patent 10758526(method of use) · relevance 75/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 1 patents →

1 AI-discovered patents, sorted by relevance.

Method of Use

(1)

75/10010758526Grant: 2020-09-01 | Exp: 2040-08-27

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 761312

351(a) ReferenceLicensedCDERFor Injection

Proper Name

denileukin diftitox-cxdl

Applicant

Citius Pharmaceuticals, Inc.

Approval Date

7-Aug-24

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 9, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MCG

▴

INJECTABLE;INJECTION | Approved: 2024-08-07 00:00:00

No patent or exclusivity listings for this strength.