Viewing data from:

PLEGRIDY

BLA

PEGINTERFERON BETA-1A | B125499 | BIOGEN IDEC INC

1 product0 Purple Book patents

Biologic LOELOE within 1 year

Estimated date when biosimilar competition may begin

August 15, 2026(43 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 15, 2026	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 9, 20457038 days remaining

Based on latest discovered patent 12441980(manufacturing) · relevance 55/100

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

Discovered Patents

View all 13 patents →

13 AI-discovered patents, sorted by relevance.

Composition

(2)

72/1007803777Grant: 2010-09-28 | Exp: 2030-09-23

50/1009409950Grant: 2016-08-09 | Exp: 2036-08-04

Formulation

(6)

92/1009522174Grant: 2016-12-20 | Exp: 2036-12-15

92/1008932574Grant: 2015-01-13 | Exp: 2035-01-08

85/1008512691Grant: 2013-08-20 | Exp: 2033-08-15

85/1009452106Grant: 2016-09-27 | Exp: 2036-09-22

75/1008784399Grant: 2014-07-22 | Exp: 2034-07-17

55/1008562967Grant: 2013-10-22 | Exp: 2033-10-17

Manufacturing

(4)

65/1009644015Grant: 2017-05-09 | Exp: 2037-05-04

55/10012441980Grant: 2025-10-14 | Exp: 2045-10-09

50/10010563163Grant: 2020-02-18 | Exp: 2040-02-13

50/1007157276Grant: 2007-01-02 | Exp: 2026-12-28

Diagnostic

(1)

75/10010961585Grant: 2021-03-30 | Exp: 2041-03-25

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 125499 | 6 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

peginterferon beta-1a

Applicant

Biogen Inc.

Approval Date

15-Aug-14

Presentations

125MCG/0.5ML — Autoinjector (Subcutaneous)

63MCG/0.5ML — Autoinjector (Subcutaneous)

94MCG/0.5ML — Autoinjector (Subcutaneous)

125MCG/0.5ML — Pre-Filled Syringe (Subcutaneous, Intramuscular)

63MCG/0.5ML — Pre-Filled Syringe (Subcutaneous)

94MCG/0.5ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jul 31, 2023	SUPPL -28	View Letter (PDF)
Mar 30, 2022	SUPPL -25	View Letter (PDF)
Nov 5, 2021	SUPPL -23	View Letter (PDF)
Feb 2, 2021	SUPPL -21	View Letter (PDF)
Mar 30, 2020	SUPPL -18	View Letter (PDF)
Jul 11, 2019	SUPPL -19	View Letter (PDF)
Jul 15, 2016	SUPPL -11	View Letter (PDF)
Dec 23, 2015	SUPPL -9	View Letter (PDF)
Aug 18, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 125MICROGRAMS/0.5ML

▴

INJECTABLE;INJECTION | Approved: 2014-08-15 00:00:00

No patent or exclusivity listings for this strength.