Viewing data from:

ELZONRIS

BLA

TAGRAXOFUSP-ERZS | B761116 | STEMLINE THERAPEUTICS INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

December 21, 2030(1632 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 21, 2030	Active	Computed
7-Year Orphan	Dec. 21, 2025	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jun. 8, 20436184 days remaining

Based on latest discovered patent 11674950(method of use) · relevance 90/100

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)

90/10011674950Grant: 2023-06-13 | Exp: 2043-06-08

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 761116

351(a) ReferenceLicensedCDERInjection

Proper Name

tagraxofusp-erzs

Applicant

Stemline Therapeutics, Inc.

Approval Date

21-Dec-18

Orphan Exclusivity

21-Dec-25

Expired

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 27, 2023	SUPPL -9	View Letter (PDF)
Nov 4, 2022	SUPPL -7	View Letter (PDF)
Oct 28, 2022	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1000MCG

▴

SOLUTION;INJECTION | Approved: 2018-12-21 00:00:00

No patent or exclusivity listings for this strength.