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INTRON A

BLA

INTERFERON ALFA-2B | B103132 | SCHERING

3 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

November 21, 1995(11182 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Nov. 21, 1995	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 12, 20446737 days remaining

Based on latest discovered patent 12168683(composition) · relevance 68/100

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

Discovered Patents

View all 33 patents →

33 AI-discovered patents, sorted by relevance.

Composition

(11)

75/10012042524Grant: 2024-07-23 | Exp: 2044-07-18

72/1007579440Grant: 2009-08-25 | Exp: 2029-08-20

72/1007615615Grant: 2009-11-10 | Exp: 2029-11-05

70/1006673775Grant: 2004-01-06 | Exp: 2024-01-01

68/10012168683Grant: 2024-12-17 | Exp: 2044-12-12

65/1007780965Grant: 2010-08-24 | Exp: 2030-08-19

65/1007071308Grant: 2006-07-04 | Exp: 2026-06-29

60/1007803777Grant: 2010-09-28 | Exp: 2030-09-23

55/1007731963Grant: 2010-06-08 | Exp: 2030-06-03

55/1007700317Grant: 2010-04-20 | Exp: 2030-04-15

55/1006307025Grant: 2001-10-23 | Exp: 2021-10-18

Formulation

(6)

75/1009522174Grant: 2016-12-20 | Exp: 2036-12-15

72/1008784399Grant: 2014-07-22 | Exp: 2034-07-17

70/1008512691Grant: 2013-08-20 | Exp: 2033-08-15

70/1008932574Grant: 2015-01-13 | Exp: 2035-01-08

65/1009452106Grant: 2016-09-27 | Exp: 2036-09-22

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

Method of Use

(6)

95/1006849254Grant: 2005-02-01 | Exp: 2025-01-27

85/1006824768Grant: 2004-11-30 | Exp: 2024-11-25

78/1006403564Grant: 2002-06-11 | Exp: 2022-06-06

75/1007816339Grant: 2010-10-19 | Exp: 2030-10-14

72/1006172046Grant: 2001-01-09 | Exp: 2021-01-04

60/1007524831Grant: 2009-04-28 | Exp: 2029-04-23

Manufacturing

(7)

60/1007531351Grant: 2009-05-12 | Exp: 2029-05-07

60/1009096879Grant: 2015-08-04 | Exp: 2035-07-30

60/1009399757Grant: 2016-07-26 | Exp: 2036-07-21

55/10011590434Grant: 2023-02-28 | Exp: 2043-02-23

55/1006660523Grant: 2003-12-09 | Exp: 2023-12-04

55/1009644015Grant: 2017-05-09 | Exp: 2037-05-04

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

Device

(1)

65/10011116911Grant: 2021-09-14 | Exp: 2041-09-09

other

(2)

50/10011104721Grant: 2021-08-31 | Exp: 2041-08-26

50/10010429129Grant: 2019-10-01 | Exp: 2039-09-26

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 103132 | 14 presentations

351(a) ReferenceVoluntarily RevokedCDERFor Injection

Proper Name

interferon alfa-2b

Applicant

Merck Sharp & Dohme LLC

Approval Date

4-Jun-86

Orphan Exclusivity

21-Nov-95

Expired

Presentations

3MIU — Single-Dose Vial (Intramuscular, Intravenous, Subcutaneous)

18MIU — Multi-Dose Vial (Subcutaneous, Intramuscular)

25MIU — Multi-Dose Vial (Intralesional, Intramuscular, Subcutaneous)

3MIU — Pre-Filled Syringe (Subcutaneous)

5MIU — Pre-Filled Syringe (Subcutaneous)

10MIU — Pre-Filled Syringe (Subcutaneous)

5MIU — Single-Dose Vial (Intramuscular, Intravenous, Subcutaneous)

10MIU — Single-Dose Vial (Subcutaneous, Intravenous, Intralesional, Intramuscular)

25MIU — Multi-Dose Vial (Intramuscular, Intravenous, Subcutaneous)

18MIU — Multi-Dose Vial (Intramuscular, Intravenous, Subcutaneous)

50MIU — Single-Dose Vial (Intramuscular, Intravenous, Subcutaneous)

3MIU — Single-Dose Vial (Subcutaneous, Intramuscular)

5MIU — Single-Dose Vial (Intralesional, Intramuscular, Subcutaneous)

10MIU — Single-Dose Vial (Intralesional, Intramuscular, Subcutaneous)

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Nov 29, 2021	SUPPL -5202	View Letter (PDF)
May 3, 2018	SUPPL -5199	View Letter (PDF)
Oct 4, 2017	SUPPL -5196	View Letter (PDF)
Jun 13, 2017	SUPPL -5195	View Letter (PDF)
May 26, 2015	SUPPL -5191	View Letter (PDF)
Aug 12, 2014	SUPPL -5190	View Letter (PDF)
Nov 18, 2013	SUPPL -5178	View Letter (PDF)
Jun 7, 2012	SUPPL -5163	View Letter (PDF)
Dec 28, 2011	SUPPL -5161	View Letter (PDF)
Feb 15, 2011	SUPPL -5143	View Letter (PDF)
May 30, 2008	SUPPL -5108	View Letter (PDF)
Jul 24, 2007	SUPPL -5096	View Letter (PDF)
May 29, 2007	SUPPL -5095	View Letter (PDF)
May 29, 2007	SUPPL -5059	View Letter (PDF)
Oct 13, 2006	SUPPL -5086	View Letter (PDF)
Jan 26, 2005	SUPPL -5064	View Letter (PDF)
Mar 17, 2004	SUPPL -1116	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MIU/VIAL

▴

VIAL | Approved: 1986-06-04 00:00:00

No patent or exclusivity listings for this strength.

#002 — 18MIU/VIAL

▾

VIAL | Approved: 1986-06-04 00:00:00

#003 — 25MIU/VIAL

▾

VIAL | Approved: 1986-06-04 00:00:00