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PEGINTRON

BLA

PEGINTERFERON ALFA-2B | B103949 | SCHERING

11 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

March 29, 2023(1192 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 29, 2023	Expired	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 26, 20394924 days remaining

Based on latest discovered patent 10519194 · 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 11 patents →

11 AI-discovered patents, sorted by relevance.

Composition

(4)

90/1007456257Grant: 2008-11-25 | Exp: 2028-11-20

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

65/1007670595Grant: 2010-03-02 | Exp: 2030-02-25

65/1007579440Grant: 2009-08-25 | Exp: 2029-08-20

Formulation

(1)

95/1007632491Grant: 2009-12-15 | Exp: 2029-12-10

Method of Use

(4)

92/1006362162Grant: 2002-03-26 | Exp: 2022-03-21

89/1006605273Grant: 2003-08-12 | Exp: 2023-08-07

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

65/1006685931Grant: 2004-02-03 | Exp: 2024-01-29

Diagnostic

(1)

92/1008535887Grant: 2013-09-17 | Exp: 2033-09-12

other

(1)

50/10010519194Grant: 2019-12-31 | Exp: 2039-12-26

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 103949 | 11 presentations

351(a) ReferenceVoluntarily RevokedCDERInjection

Proper Name

peginterferon alfa-2b

Applicant

Merck Sharp & Dohme LLC

Approval Date

19-Jan-01

Presentations

50MCG/0.5ML — Single-Dose Vial (Subcutaneous)

150MCG/0.5ML — Autoinjector (Subcutaneous)

150MCG/0.5ML — Single-Dose Vial (Subcutaneous)

200MCG — Single-Dose Vial (Subcutaneous)

300MCG — Single-Dose Vial (Subcutaneous)

600MCG — Single-Dose Vial (Subcutaneous)

50MCG/0.5ML — Autoinjector (Subcutaneous)

80MCG/0.5ML — Autoinjector (Subcutaneous)

80MCG/0.5ML — Single-Dose Vial (Subcutaneous)

120MCG/0.5ML — Autoinjector (Subcutaneous)

120MCG/0.5ML — Single-Dose Vial (Subcutaneous)

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

Approval Letters

39 letters from Drugs@FDA

Date	Submission	Document
Jan 23, 2019	SUPPL -5313	View Letter (PDF)
Dec 31, 2018	SUPPL -5312	View Letter (PDF)
May 29, 2018	SUPPL -5311	View Letter (PDF)
May 3, 2018	SUPPL -5310	View Letter (PDF)
Oct 5, 2017	SUPPL -5306	View Letter (PDF)
Oct 4, 2017	SUPPL -5305	View Letter (PDF)
Oct 4, 2017	SUPPL -5307	View Letter (PDF)
May 26, 2017	SUPPL -5304	View Letter (PDF)
Sep 17, 2015	SUPPL -5299	View Letter (PDF)
May 22, 2015	SUPPL -5297	View Letter (PDF)
May 19, 2015	SUPPL -5298	View Letter (PDF)
Nov 19, 2014	SUPPL -5293	View Letter (PDF)
Oct 10, 2014	SUPPL -5296	View Letter (PDF)
Sep 8, 2014	SUPPL -5287	View Letter (PDF)
Aug 15, 2014	SUPPL -5285	View Letter (PDF)
Aug 12, 2014	SUPPL -5288	View Letter (PDF)
Aug 1, 2014	SUPPL -5295	View Letter (PDF)
Dec 20, 2013	SUPPL -5259	View Letter (PDF)
Nov 25, 2013	SUPPL -5273	View Letter (PDF)
May 16, 2013	SUPPL -5263	View Letter (PDF)
Dec 28, 2012	SUPPL -5252	View Letter (PDF)
Jul 9, 2012	SUPPL -5232	View Letter (PDF)
Jun 7, 2012	SUPPL -5231	View Letter (PDF)
Dec 28, 2011	SUPPL -5217	View Letter (PDF)
Dec 28, 2011	SUPPL -5222	View Letter (PDF)
Dec 13, 2011	SUPPL -5204	View Letter (PDF)
Mar 31, 2011	SUPPL -5153	View Letter (PDF)
Feb 15, 2011	SUPPL -5201	View Letter (PDF)
Jun 10, 2009	SUPPL -5175	View Letter (PDF)
Jun 8, 2009	SUPPL -5172	View Letter (PDF)
Mar 23, 2009	SUPPL -5125	View Letter (PDF)
Dec 24, 2008	SUPPL -5171	View Letter (PDF)
Dec 24, 2008	SUPPL -5174	View Letter (PDF)
Jan 16, 2007	SUPPL -5124	View Letter (PDF)
Nov 3, 2005	SUPPL -5077	View Letter (PDF)
Aug 8, 2005	SUPPL -5105	View Letter (PDF)
Jan 26, 2005	SUPPL -5088	View Letter (PDF)
Mar 25, 2004	SUPPL -5002	View Letter (PDF)
Mar 25, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (11)

Sort:

#001 — 50UG/0.5ML

▴

VIAL | Approved: 2001-01-19 00:00:00

No patent or exclusivity listings for this strength.

#002 — 80UG/0.5ML

▾

VIAL | Approved: 2001-01-19 00:00:00

#003 — 120UG/0.5ML

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VIAL | Approved: 2001-01-19 00:00:00

#004 — 150UG/0.5ML

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VIAL | Approved: 2001-01-19 00:00:00

#005 — 50UG/0.5ML

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SYRINGE | Approved: 2001-01-19 00:00:00

#006 — 80UG/0.5ML

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SYRINGE | Approved: 2001-01-19 00:00:00

#007 — 150UG/0.5ML

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SYRINGE | Approved: 2001-01-19 00:00:00

#008 — 120UG/0.5ML

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SYRINGE | Approved: 2001-01-19 00:00:00

#009 — 296 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL

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VIAL | Approved: 2001-01-19 00:00:00

#010 — 444 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL

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VIAL | Approved: 2001-01-19 00:00:00

#011 — 888 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL

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VIAL | Approved: 2001-01-19 00:00:00