Viewing data from:

VECTIBIX

BLA

PANITUMUMAB | B125147 | AMGEN

3 products0 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

Mar. 20, 20456835 days remaining

Based on latest discovered patent 12257343(formulation) · relevance 78/100

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

Discovered Patents

View all 96 patents →

Top 50 of 96 AI-discovered patents by relevance.

Composition

(10)

88/1008628773Grant: 2014-01-14 | Exp: 2034-01-09

85/10011629193Grant: 2023-04-18 | Exp: 2043-04-13

80/1009605074Grant: 2017-03-28 | Exp: 2037-03-23

75/1007820877Grant: 2010-10-26 | Exp: 2030-10-21

75/1007064244Grant: 2006-06-20 | Exp: 2026-06-15

75/10010130680Grant: 2018-11-20 | Exp: 2038-11-15

70/1007435871Grant: 2008-10-14 | Exp: 2028-10-09

68/1007498029Grant: 2009-03-03 | Exp: 2029-02-26

65/1008444990Grant: 2013-05-21 | Exp: 2033-05-16

65/1009073999Grant: 2015-07-07 | Exp: 2035-07-02

Formulation

(8)

92/1008241632Grant: 2012-08-14 | Exp: 2032-08-09

78/10012257343Grant: 2025-03-25 | Exp: 2045-03-20

75/1009352043Grant: 2016-05-31 | Exp: 2036-05-26

75/1008858935Grant: 2014-10-14 | Exp: 2034-10-09

72/1007705132Grant: 2010-04-27 | Exp: 2030-04-22

72/10010653781Grant: 2020-05-19 | Exp: 2040-05-14

65/1007956160Grant: 2011-06-07 | Exp: 2031-06-02

65/10012103979Grant: 2024-10-01 | Exp: 2044-09-26

Method of Use

(9)

96/1009097729Grant: 2015-08-04 | Exp: 2035-07-30

92/1007985559Grant: 2011-07-26 | Exp: 2031-07-21

88/1009522956Grant: 2016-12-20 | Exp: 2036-12-15

80/10010030270Grant: 2018-07-24 | Exp: 2038-07-19

78/1009566334Grant: 2017-02-14 | Exp: 2037-02-09

75/10010758526Grant: 2020-09-01 | Exp: 2040-08-27

72/10010024844Grant: 2018-07-17 | Exp: 2038-07-12

65/1009803025Grant: 2017-10-31 | Exp: 2037-10-26

65/1007449442Grant: 2008-11-11 | Exp: 2028-11-06

Manufacturing

(15)

82/10011447547Grant: 2022-09-20 | Exp: 2042-09-15

75/1006673986Grant: 2004-01-06 | Exp: 2024-01-01

75/1008809051Grant: 2014-08-19 | Exp: 2034-08-14

75/1006833268Grant: 2004-12-21 | Exp: 2024-12-16

75/10011685772Grant: 2023-06-27 | Exp: 2043-06-22

72/10011459595Grant: 2022-10-04 | Exp: 2042-09-29

72/10011952605Grant: 2024-04-09 | Exp: 2044-04-04

70/1007049426Grant: 2006-05-23 | Exp: 2026-05-18

70/1008263750Grant: 2012-09-11 | Exp: 2032-09-06

65/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

65/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

65/1008354105Grant: 2013-01-15 | Exp: 2033-01-10

65/1007547817Grant: 2009-06-16 | Exp: 2029-06-11

65/1006657103Grant: 2003-12-02 | Exp: 2023-11-27

65/10010167492Grant: 2019-01-01 | Exp: 2038-12-27

Device

(4)

72/10010492990Grant: 2019-12-03 | Exp: 2039-11-28

68/10010092706Grant: 2018-10-09 | Exp: 2038-10-04

65/10011944798Grant: 2024-04-02 | Exp: 2044-03-28

65/10011419990Grant: 2022-08-23 | Exp: 2042-08-18

Diagnostic

(4)

85/10011155876Grant: 2021-10-26 | Exp: 2041-10-21

82/1007981605Grant: 2011-07-19 | Exp: 2031-07-14

75/10010697022Grant: 2020-06-30 | Exp: 2040-06-25

72/10012098428Grant: 2024-09-24 | Exp: 2044-09-19

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 125147 | 3 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

panitumumab

Applicant

Amgen Inc.

Approval Date

27-Sep-06

Presentations

100MG/5ML (20MG/ML) — Single-Dose Vial (Intravenous)

400MG/20ML (20MG/ML) — Single-Dose Vial (Intravenous)

200MG/10ML (20MG/ML) — Single-Dose Vial (Intravenous)

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2025	SUPPL -213	View Letter (PDF)
Aug 27, 2021	SUPPL -210	View Letter (PDF)
Jul 5, 2017	SUPPL -207	View Letter (PDF)
Mar 12, 2015	SUPPL -200	View Letter (PDF)
Sep 3, 2014	SUPPL -194	View Letter (PDF)
May 27, 2014	SUPPL -186	View Letter (PDF)
May 27, 2014	SUPPL -108	View Letter (PDF)
Apr 1, 2013	SUPPL -169	View Letter (PDF)
Aug 27, 2012	SUPPL -152	View Letter (PDF)
Aug 21, 2012	SUPPL -148	View Letter (PDF)
May 8, 2009	SUPPL -67	View Letter (PDF)
Jul 8, 2008	SUPPL -26	View Letter (PDF)
Nov 19, 2007	SUPPL -18	View Letter (PDF)
Oct 2, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5ML/100MG

▴

INJECTABLE; IV (INFUSION) | Approved: 2006-09-27 00:00:00

No patent or exclusivity listings for this strength.

#002 — 10ML/200MG

▾

INJECTABLE; IV (INFUSION) | Approved: 2006-09-27 00:00:00

#003 — 20ML/400MG

▾

INJECTABLE; IV (INFUSION) | Approved: 2006-09-27 00:00:00