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PORTRAZZA

BLA

NECITUMUMAB | B125547 | ELI LILLY CO

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 24, 2027(509 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 24, 2027	Active	Computed
7-Year Orphan	Nov. 24, 2022	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 18, 20457017 days remaining

Based on latest discovered patent 12421294(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

(16)

88/1009815788Grant: 2017-11-14 | Exp: 2037-11-09

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

85/10010391180Grant: 2019-08-27 | Exp: 2039-08-22

85/1009840561Grant: 2017-12-12 | Exp: 2037-12-07

82/10012053491Grant: 2024-08-06 | Exp: 2044-08-01

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

78/10010100281Grant: 2018-10-16 | Exp: 2038-10-11

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

72/1008461114Grant: 2013-06-11 | Exp: 2033-06-06

72/1009328173Grant: 2016-05-03 | Exp: 2036-04-28

70/10011155783Grant: 2021-10-26 | Exp: 2041-10-21

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

68/10012421294Grant: 2025-09-23 | Exp: 2045-09-18

62/10010188728Grant: 2019-01-29 | Exp: 2039-01-24

55/10011976136Grant: 2024-05-07 | Exp: 2044-05-02

50/10010774156Grant: 2020-09-15 | Exp: 2040-09-10

Formulation

(2)

72/1008871201Grant: 2014-10-28 | Exp: 2034-10-23

55/1006440930Grant: 2002-08-27 | Exp: 2022-08-22

Method of Use

(10)

92/10011879012Grant: 2024-01-23 | Exp: 2044-01-18

85/10012201719Grant: 2025-01-21 | Exp: 2045-01-16

78/1008715665Grant: 2014-05-06 | Exp: 2034-05-01

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

75/1009580685Grant: 2017-02-28 | Exp: 2037-02-23

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

70/10011008620Grant: 2021-05-18 | Exp: 2041-05-13

70/10011471457Grant: 2022-10-18 | Exp: 2042-10-13

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

50/1009789201Grant: 2017-10-17 | Exp: 2037-10-12

Manufacturing

(2)

50/10010294307Grant: 2019-05-21 | Exp: 2039-05-16

50/10010047167Grant: 2018-08-14 | Exp: 2038-08-09

Diagnostic

(3)

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

70/1008389227Grant: 2013-03-05 | Exp: 2033-02-28

50/10012098428Grant: 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 125547

351(a) ReferenceLicensedCDERInjection

Proper Name

necitumumab

Applicant

Eli Lilly and Company

Approval Date

24-Nov-15

Orphan Exclusivity

24-Nov-22

Expired

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 24, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 800MG/50ML

▴

INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL | Approved: 2015-11-24 00:00:00

No patent or exclusivity listings for this strength.