Viewing data from:

BESREMI

BLA

ROPEGINTERFERON ALFA-2B-NJFT | B761166 | PHARMAESSENTIA CORP

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 12, 2033(2689 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 12, 2033	Active	Computed
7-Year Orphan	Nov. 12, 2028	Active	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 26, 20332733 days remaining

Based on latest discovered patent 8617532(composition) · relevance 85/100

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

Discovered Patents

View all 3 patents →

3 AI-discovered patents, sorted by relevance.

Composition

(3)

85/1008106160Grant: 2012-01-31 | Exp: 2032-01-26

85/1008617532Grant: 2013-12-31 | Exp: 2033-12-26

55/1008143214Grant: 2012-03-27 | Exp: 2032-03-22

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 761166

351(a) ReferenceLicensedCDERInjection

Proper Name

ropeginterferon alfa-2b-njft

Applicant

PharmaEssentia Corporation

Approval Date

12-Nov-21

Orphan Exclusivity

12-Nov-28

2y 4mo remaining

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 29, 2026	SUPPL -10	View Letter (PDF)
Apr 30, 2024	SUPPL -7	View Letter (PDF)
Nov 16, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500 MCG/ML

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2021-11-12 00:00:00

No patent or exclusivity listings for this strength.