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BLA

CONCIZUMAB-MTCI | B761315 | NOVO NORDISK INC

3 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

December 20, 2036(3823 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 20, 2036	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Mar. 6, 20456821 days remaining

Based on latest discovered patent 12249425(device) · relevance 75/100

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

Discovered Patents

View all 238 patents →

Top 50 of 238 AI-discovered patents by relevance.

Composition

(21)

95/1006903069Grant: 2005-06-07 | Exp: 2025-06-02

92/1009187546Grant: 2015-11-17 | Exp: 2035-11-12

92/1007432352Grant: 2008-10-07 | Exp: 2028-10-02

92/1008674074Grant: 2014-03-18 | Exp: 2034-03-13

90/10010919949Grant: 2021-02-16 | Exp: 2041-02-11

88/1006228620Grant: 2001-05-08 | Exp: 2021-05-03

88/1009474790Grant: 2016-10-25 | Exp: 2036-10-20

88/1009018166Grant: 2015-04-28 | Exp: 2035-04-23

85/1007087408Grant: 2006-08-08 | Exp: 2026-08-03

85/1007235638Grant: 2007-06-26 | Exp: 2027-06-21

85/1008987197Grant: 2015-03-24 | Exp: 2035-03-19

85/10011208452Grant: 2021-12-28 | Exp: 2041-12-23

85/1008883449Grant: 2014-11-11 | Exp: 2034-11-06

85/1006521738Grant: 2003-02-18 | Exp: 2023-02-13

85/100OB11318191Grant: 2022-05-03 | Exp: 2042-04-28

85/10011274280Grant: 2022-03-15 | Exp: 2042-03-10

85/1008710001Grant: 2014-04-29 | Exp: 2034-04-24

85/1009062115Grant: 2015-06-23 | Exp: 2035-06-18

82/1008853161Grant: 2014-10-07 | Exp: 2034-10-02

78/1008916360Grant: 2014-12-23 | Exp: 2034-12-18

75/1009963496Grant: 2018-05-08 | Exp: 2038-05-03

Formulation

(3)

95/10010835602Grant: 2020-11-17 | Exp: 2040-11-12

85/1009034818Grant: 2015-05-19 | Exp: 2035-05-14

85/1009795674Grant: 2017-10-24 | Exp: 2037-10-19

Method of Use

(6)

92/1009029324Grant: 2015-05-12 | Exp: 2035-05-07

85/1006268163Grant: 2001-07-31 | Exp: 2021-07-26

85/1007419949Grant: 2008-09-02 | Exp: 2028-08-28

85/1006461610Grant: 2002-10-08 | Exp: 2022-10-03

82/10011203636Grant: 2021-12-21 | Exp: 2041-12-16

75/10011373746Grant: 2022-06-28 | Exp: 2042-06-23

Manufacturing

(17)

85/1009056921Grant: 2015-06-16 | Exp: 2035-06-11

85/1008129146Grant: 2012-03-06 | Exp: 2032-03-01

85/1008940504Grant: 2015-01-27 | Exp: 2035-01-22

85/1008202973Grant: 2012-06-19 | Exp: 2032-06-14

85/1006777207Grant: 2004-08-17 | Exp: 2024-08-12

85/1007947471Grant: 2011-05-24 | Exp: 2031-05-19

85/1006566490Grant: 2003-05-20 | Exp: 2023-05-15

85/1006933136Grant: 2005-08-23 | Exp: 2025-08-18

85/1007105314Grant: 2006-09-12 | Exp: 2026-09-07

85/1007521210Grant: 2009-04-21 | Exp: 2029-04-16

85/10011787837Grant: 2023-10-17 | Exp: 2043-10-12

85/1007402565Grant: 2008-07-22 | Exp: 2028-07-17

85/1008008252Grant: 2011-08-30 | Exp: 2031-08-25

82/1007378390Grant: 2008-05-27 | Exp: 2028-05-22

82/1008158771Grant: 2012-04-17 | Exp: 2032-04-12

75/10012024542Grant: 2024-07-02 | Exp: 2044-06-27

75/1006451987Grant: 2002-09-17 | Exp: 2022-09-12

Device

(2)

75/10012249425Grant: 2025-03-11 | Exp: 2045-03-06

75/10011373759Grant: 2022-06-28 | Exp: 2042-06-23

Diagnostic

(1)

90/1009080200Grant: 2015-07-14 | Exp: 2035-07-09

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 761315 | 3 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

concizumab-mtci

Applicant

Novo Nordisk Inc.

Approval Date

20-Dec-24

Presentations

60MG/1.5ML (40MG/ML) — Autoinjector (Subcutaneous)

150MG/1.5ML (100MG/ML) — Autoinjector (Subcutaneous)

300MG/3ML (100MG/ML) — Autoinjector (Subcutaneous)

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 1, 2025	SUPPL -3	View Letter (PDF)
Dec 27, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 60MG/1.5ML(40MG/ML)

▴

Injectable; Subcutaneous | Approved: 2024-12-20 00:00:00

No patent or exclusivity listings for this strength.

#002 — 150MG/1.5ML(100MG/ML)

▾

Injectable; Subcutaneous | Approved: 2024-12-20 00:00:00

#003 — 300MG/3ML(100MG/ML)

▾

Injectable; Subcutaneous | Approved: 2024-12-20 00:00:00