Viewing data from:

BETASERON

BLA

INTERFERON BETA-1B | B103471 | BAYER HEALTHCARE PHARMS

1 product0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 21, 20436380 days remaining

Based on latest discovered patent 11851666(manufacturing) · relevance 50/100

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

Discovered Patents

View all 12 patents →

12 AI-discovered patents, sorted by relevance.

Formulation

(5)

85/1006887462Grant: 2005-05-03 | Exp: 2025-04-28

85/1007371373Grant: 2008-05-13 | Exp: 2028-05-08

85/1007399463Grant: 2008-07-15 | Exp: 2028-07-10

85/1007662369Grant: 2010-02-16 | Exp: 2030-02-11

58/10010689451Grant: 2020-06-23 | Exp: 2040-06-18

Manufacturing

(5)

55/1009243224Grant: 2016-01-26 | Exp: 2036-01-21

55/10011230718Grant: 2022-01-25 | Exp: 2042-01-20

50/1009994866Grant: 2018-06-12 | Exp: 2038-06-07

50/1007836606Grant: 2010-11-23 | Exp: 2030-11-18

50/10011851666Grant: 2023-12-26 | Exp: 2043-12-21

Diagnostic

(2)

75/1006284473Grant: 2001-09-04 | Exp: 2021-08-30

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
BIOGEN IDEC MA INC. v. EMD SERONO, INC. et al 2:2010cv02760 1 patentinterferon-beta	D.N.J.	2010-05-28	Terminated 2010-10-06	—
BAYER HEALTHCARE PHARMACEUTICALS INC. v. BIOGEN IDEC MA INC. 2:2010cv02734 1 patentInterferon beta-1a	D.N.J.	2010-05-27	Terminated 2021-03-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 103471

351(a) ReferenceLicensedCDERFor Injection

Proper Name

interferon beta-1b

Applicant

Bayer HealthCare Pharmaceuticals Inc.

Approval Date

23-Jul-93

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

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
May 10, 2024	SUPPL -5203	View Letter (PDF)
Jul 31, 2023	SUPPL -5202	View Letter (PDF)
Sep 6, 2022	SUPPL -5201	View Letter (PDF)
Nov 5, 2021	SUPPL -5200	View Letter (PDF)
Mar 17, 2021	SUPPL -5199	View Letter (PDF)
Oct 2, 2020	SUPPL -5197	View Letter (PDF)
Aug 20, 2019	SUPPL -5195	View Letter (PDF)
Sep 13, 2018	SUPPL -5193	View Letter (PDF)
Jun 14, 2018	SUPPL -5191	View Letter (PDF)
May 31, 2017	SUPPL -5189	View Letter (PDF)
Apr 22, 2016	SUPPL -5187	View Letter (PDF)
Dec 23, 2015	SUPPL -5188	View Letter (PDF)
Sep 28, 2015	SUPPL -5186	View Letter (PDF)
Jan 29, 2014	SUPPL -5185	View Letter (PDF)
Jul 2, 2013	SUPPL -5125	View Letter (PDF)
Dec 13, 2012	SUPPL -5138	View Letter (PDF)
Dec 13, 2012	SUPPL -5067	View Letter (PDF)
Dec 13, 2012	SUPPL -5120	View Letter (PDF)
Dec 13, 2012	SUPPL -5136	View Letter (PDF)
Dec 13, 2012	SUPPL -5063	View Letter (PDF)
Dec 13, 2012	SUPPL -5079	View Letter (PDF)
Dec 13, 2012	SUPPL -5088	View Letter (PDF)
Dec 13, 2012	SUPPL -5124	View Letter (PDF)
Mar 11, 2004	SUPPL -1039	View Letter (PDF)
Oct 31, 2003	SUPPL -5032	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.3 MG

▴

VIAL; SUBCUTANEOUS | Approved: 1993-07-23 00:00:00

No patent or exclusivity listings for this strength.