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BLA

OBILTOXAXIMAB | B125509 | ELUSYS THERAPEUTICS INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

March 18, 2028(624 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 18, 2028	Active	Computed
7-Year Orphan	Mar. 18, 2023	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 13, 20374028 days remaining

Based on latest discovered patent 9708374(composition) · relevance 82/100

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.

Composition

(1)

82/1009708374Grant: 2017-07-18 | Exp: 2037-07-13

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 125509

351(a) ReferenceLicensedCDERInjection

Proper Name

obiltoxaximab

Applicant

Elusys Therapeutics, Inc.

Approval Date

18-Mar-16

Orphan Exclusivity

18-Mar-23

Expired

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 2, 2019	SUPPL -15	View Letter (PDF)
Mar 28, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG/6ML

▴

INJECTABLE;INJECTION | Approved: 2016-03-18 00:00:00

No patent or exclusivity listings for this strength.