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BLA

CRIZANLIZUMAB-TMCA | B761128 | NOVARTIS PHARMS CORP

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 15, 2031(1961 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 15, 2031	Active	Computed
7-Year Orphan	Nov. 15, 2026	Active	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 24, 20456961 days remaining

Based on latest discovered patent 12371510(manufacturing) · 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 36 patents →

36 AI-discovered patents, sorted by relevance.

Composition

(16)

92/1009068001Grant: 2015-06-30 | Exp: 2035-06-25

70/10010117953Grant: 2018-11-06 | Exp: 2038-11-01

65/1006383487Grant: 2002-05-07 | Exp: 2022-05-02

65/1008551482Grant: 2013-10-08 | Exp: 2033-10-03

65/1009982046Grant: 2018-05-29 | Exp: 2038-05-24

60/1008747848Grant: 2014-06-10 | Exp: 2034-06-05

55/1009676841Grant: 2017-06-13 | Exp: 2037-06-08

55/10011596695Grant: 2023-03-07 | Exp: 2043-03-02

55/1008088383Grant: 2012-01-03 | Exp: 2031-12-29

55/1009409979Grant: 2016-08-09 | Exp: 2036-08-04

50/10011046757Grant: 2021-06-29 | Exp: 2041-06-24

50/10010781268Grant: 2020-09-22 | Exp: 2040-09-17

50/1009629925Grant: 2017-04-25 | Exp: 2037-04-20

50/10011312783Grant: 2022-04-26 | Exp: 2042-04-21

50/10011685776Grant: 2023-06-27 | Exp: 2043-06-22

50/10010787480Grant: 2020-09-29 | Exp: 2040-09-24

Formulation

(5)

68/10010689451Grant: 2020-06-23 | Exp: 2040-06-18

62/1009751951Grant: 2017-09-05 | Exp: 2037-08-31

55/1009216219Grant: 2015-12-22 | Exp: 2035-12-17

50/10010899841Grant: 2021-01-26 | Exp: 2041-01-21

50/10012054555Grant: 2024-08-06 | Exp: 2044-08-01

Method of Use

(1)

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

Manufacturing

(14)

72/10011767370Grant: 2023-09-26 | Exp: 2043-09-21

65/1009994645Grant: 2018-06-12 | Exp: 2038-06-07

55/1009243224Grant: 2016-01-26 | Exp: 2036-01-21

55/10010667935Grant: 2020-06-02 | Exp: 2040-05-28

55/1009758779Grant: 2017-09-12 | Exp: 2037-09-07

55/10010370456Grant: 2019-08-06 | Exp: 2039-08-01

52/1009505803Grant: 2016-11-29 | Exp: 2036-11-24

50/10011512335Grant: 2022-11-29 | Exp: 2042-11-24

50/1009663552Grant: 2017-05-30 | Exp: 2037-05-25

50/10012371510Grant: 2025-07-29 | Exp: 2045-07-24

50/1008986957Grant: 2015-03-24 | Exp: 2035-03-19

50/1009994866Grant: 2018-06-12 | Exp: 2038-06-07

50/10011174494Grant: 2021-11-16 | Exp: 2041-11-11

50/10010406198Grant: 2019-09-10 | Exp: 2039-09-05

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 761128

351(a) ReferenceLicensedCDERInjection

Proper Name

crizanlizumab-tmca

Applicant

Novartis Pharmaceuticals Corporation

Approval Date

15-Nov-19

Orphan Exclusivity

15-Nov-26

4mo 14d remaining

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jun 28, 2024	SUPPL -6	View Letter (PDF)
Sep 9, 2022	SUPPL -5	View Letter (PDF)
Jul 14, 2021	SUPPL -1	View Letter (PDF)
Nov 19, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/10ML

▴

INJECTABLE; INJECTION | Approved: 2019-11-15 00:00:00

No patent or exclusivity listings for this strength.