Viewing data from:

PEGASYS

BLA

PEGINTERFERON ALFA-2A | B103964 | Pharmaand GmbH

2 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

September 29, 2023(1008 days ago)

Regulatory Exclusivities

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

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jan. 23, 20456779 days remaining

Based on latest discovered patent 12208142(manufacturing) · 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 34 patents →

34 AI-discovered patents, sorted by relevance.

Composition

(14)

95/1007201897Grant: 2007-04-10 | Exp: 2027-04-05

92/1007318918Grant: 2008-01-15 | Exp: 2028-01-10

75/1007128913Grant: 2006-10-31 | Exp: 2026-10-26

72/1006870033Grant: 2005-03-22 | Exp: 2025-03-17

70/1007479544Grant: 2009-01-20 | Exp: 2029-01-15

70/1008476232Grant: 2013-07-02 | Exp: 2033-06-27

70/1006936695Grant: 2005-08-30 | Exp: 2025-08-25

65/1006583272Grant: 2003-06-24 | Exp: 2023-06-19

65/1007193031Grant: 2007-03-20 | Exp: 2027-03-15

65/1007005504Grant: 2006-02-28 | Exp: 2026-02-23

60/1009587006Grant: 2017-03-07 | Exp: 2037-03-02

55/10012090211Grant: 2024-09-17 | Exp: 2044-09-12

55/1007608681Grant: 2009-10-27 | Exp: 2029-10-22

55/1009724425Grant: 2017-08-08 | Exp: 2037-08-03

Formulation

(7)

70/1007202208Grant: 2007-04-10 | Exp: 2027-04-05

70/1007504477Grant: 2009-03-17 | Exp: 2029-03-12

65/10011865177Grant: 2024-01-09 | Exp: 2044-01-04

55/1007169754Grant: 2007-01-30 | Exp: 2027-01-25

50/10010933141Grant: 2021-03-02 | Exp: 2041-02-25

50/10010525137Grant: 2020-01-07 | Exp: 2040-01-02

50/1009662395Grant: 2017-05-30 | Exp: 2037-05-25

Method of Use

(1)

62/1009295669Grant: 2016-03-29 | Exp: 2036-03-24

Manufacturing

(10)

85/10011518781Grant: 2022-12-06 | Exp: 2042-12-01

85/10012208142Grant: 2025-01-28 | Exp: 2045-01-23

65/1007897404Grant: 2011-03-01 | Exp: 2031-02-24

55/1009884904Grant: 2018-02-06 | Exp: 2038-02-01

55/10010590164Grant: 2020-03-17 | Exp: 2040-03-12

50/10011905325Grant: 2024-02-20 | Exp: 2044-02-15

50/1006395484Grant: 2002-05-28 | Exp: 2022-05-23

50/1009657054Grant: 2017-05-23 | Exp: 2037-05-18

50/10010112994Grant: 2018-10-30 | Exp: 2038-10-25

50/10011028149Grant: 2021-06-08 | Exp: 2041-06-03

Device

(1)

50/1009522227Grant: 2016-12-20 | Exp: 2036-12-15

Diagnostic

(1)

70/1007504217Grant: 2009-03-17 | Exp: 2029-03-12

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 103964 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

peginterferon alfa-2a

Applicant

pharmaand GmbH

Approval Date

16-Oct-02

Presentations

180MCG/ML — Single-Dose Vial (Subcutaneous)

180MCG/0.5ML — Pre-Filled Syringe (Subcutaneous)

180MCG/0.5ML — Autoinjector (Subcutaneous)

135MCG/0.5ML — Autoinjector (Subcutaneous)

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

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Dec 12, 2023	SUPPL -5276	View Letter (PDF)
Mar 25, 2021	SUPPL -5275	View Letter (PDF)
Oct 16, 2020	SUPPL -5273	View Letter (PDF)
Oct 18, 2017	SUPPL -5270	View Letter (PDF)
Mar 19, 2015	SUPPL -5264	View Letter (PDF)
Sep 8, 2014	SUPPL -5261	View Letter (PDF)
Jul 3, 2013	SUPPL -5245	View Letter (PDF)
May 21, 2013	SUPPL -5241	View Letter (PDF)
Oct 5, 2011	SUPPL -5204	View Letter (PDF)
Aug 26, 2011	SUPPL -5213	View Letter (PDF)
Aug 11, 2011	SUPPL -5186	View Letter (PDF)
Mar 2, 2011	SUPPL -5183	View Letter (PDF)
Jun 29, 2010	SUPPL -5176	View Letter (PDF)
Mar 31, 2010	SUPPL -5177	View Letter (PDF)
May 8, 2009	SUPPL -5147	View Letter (PDF)
May 8, 2009	SUPPL -5163	View Letter (PDF)
Nov 7, 2008	SUPPL -5133	View Letter (PDF)
Oct 2, 2008	SUPPL -5154	View Letter (PDF)
Jul 5, 2007	SUPPL -5120	View Letter (PDF)
May 20, 2005	SUPPL -5057	View Letter (PDF)
May 20, 2005	SUPPL -5065	View Letter (PDF)
May 20, 2005	SUPPL -5037	View Letter (PDF)
Mar 3, 2005	SUPPL -5039	View Letter (PDF)
Jan 26, 2005	SUPPL -5036	View Letter (PDF)
Mar 25, 2004	SUPPL -5000	View Letter (PDF)
Mar 25, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 180UG/VIAL

▴

VIAL; SUBCUTANEOUS | Approved: 2002-10-16 00:00:00

No patent or exclusivity listings for this strength.

#002 — 180U/5ML

▾

SYRINGE | Approved: 2002-10-16 00:00:00