Viewing data from:

MARGENZA

BLA

MARGETUXIMAB-CMKB | B761150 | TERSERA THERAPEUTICS LLC

1 product0 Purple Book patents

Biologic LOELicensure floor passed

No 12-year reference-product exclusivity floor found in the Purple Book

No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 16, 2020 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.

Marketing-entry ceiling (litigation risk)

Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.

Apr. 3, 20456725 days remaining

Latest formulation/compound patent 12269876(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.

38 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 11 device/diagnostic/manufacturing

Patent	Class	Expiration	Source
12421299	Other	Sep. 18, 2045Active	Discovered
12269876	Formulation/compound	Apr. 3, 2045Active	Discovered
12269867	Other	Apr. 3, 2045Active	Discovered
12173080	Other	Dec. 19, 2044Active	Discovered
11802165	Other	Oct. 26, 2043Active	Discovered
11795226	Formulation/compound	Oct. 19, 2043Active	Discovered
11787871	Formulation/compound	Oct. 12, 2043Active	Discovered
11718678	Formulation/compound	Aug. 3, 2043Active	Discovered
11680110	Other	Jun. 15, 2043Active	Discovered
11596620	Formulation/compound	Mar. 2, 2043Active	Discovered
11530275	Formulation/compound	Dec. 15, 2042Active	Discovered
11459399	Formulation/compound	Sep. 29, 2042Active	Discovered
11440971	Formulation/compound	Sep. 8, 2042Active	Discovered
11078279	Formulation/compound	Jul. 29, 2041Active	Discovered
10975168	Other	Apr. 8, 2041Active	Discovered

Showing 15 of 50 patents (latest expirations).

Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.

Discovered Patents

View all 201 patents →

Top 50 of 201 AI-discovered patents by relevance.

Composition

(35)

92/1008445645Grant: 2013-05-21 | Exp: 2033-05-16

90/10011078279Grant: 2021-08-03 | Exp: 2041-07-29

85/1009096877Grant: 2015-08-04 | Exp: 2035-07-30

85/1009708408Grant: 2017-07-18 | Exp: 2037-07-13

85/1007741072Grant: 2010-06-22 | Exp: 2030-06-17

85/1008951517Grant: 2015-02-10 | Exp: 2035-02-05

85/10010711069Grant: 2020-07-14 | Exp: 2040-07-09

85/1006800738Grant: 2004-10-05 | Exp: 2024-09-30

85/1007355008Grant: 2008-04-08 | Exp: 2028-04-03

85/10011787871Grant: 2023-10-17 | Exp: 2043-10-12

85/1008652466Grant: 2014-02-18 | Exp: 2034-02-13

82/10011795226Grant: 2023-10-24 | Exp: 2043-10-19

82/1008192737Grant: 2012-06-05 | Exp: 2032-05-31

80/1008216574Grant: 2012-07-10 | Exp: 2032-07-05

78/1007960512Grant: 2011-06-14 | Exp: 2031-06-09

78/10010618965Grant: 2020-04-14 | Exp: 2040-04-09

75/10012269876Grant: 2025-04-08 | Exp: 2045-04-03

75/1006528624Grant: 2003-03-04 | Exp: 2023-02-27

75/10011440971Grant: 2022-09-13 | Exp: 2042-09-08

75/10011718678Grant: 2023-08-08 | Exp: 2043-08-03

75/10010766960Grant: 2020-09-08 | Exp: 2040-09-03

75/1007364731Grant: 2008-04-29 | Exp: 2028-04-24

75/1008187593Grant: 2012-05-29 | Exp: 2032-05-24

75/1007297775Grant: 2007-11-20 | Exp: 2027-11-15

75/1006242195Grant: 2001-06-05 | Exp: 2021-05-31

75/10011530275Grant: 2022-12-20 | Exp: 2042-12-15

75/1006194551Grant: 2001-02-27 | Exp: 2021-02-22

75/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

72/10010919953Grant: 2021-02-16 | Exp: 2041-02-11

72/1008957187Grant: 2015-02-17 | Exp: 2035-02-12

72/10010844113Grant: 2020-11-24 | Exp: 2040-11-19

72/1007521542Grant: 2009-04-21 | Exp: 2029-04-16

72/1008216579Grant: 2012-07-10 | Exp: 2032-07-05

70/1008530627Grant: 2013-09-10 | Exp: 2033-09-05

70/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

Formulation

(3)

95/10011459399Grant: 2022-10-04 | Exp: 2042-09-29

72/10011596620Grant: 2023-03-07 | Exp: 2043-03-02

71/1009254321Grant: 2016-02-09 | Exp: 2036-02-04

Method of Use

(1)

80/1008828666Grant: 2014-09-09 | Exp: 2034-09-04

Manufacturing

(11)

85/10012173080Grant: 2024-12-24 | Exp: 2044-12-19

75/10012269867Grant: 2025-04-08 | Exp: 2045-04-03

75/10011802165Grant: 2023-10-31 | Exp: 2043-10-26

75/10011680110Grant: 2023-06-20 | Exp: 2043-06-15

75/1007038017Grant: 2006-05-02 | Exp: 2026-04-27

75/1008574869Grant: 2013-11-05 | Exp: 2033-10-31

75/1007575893Grant: 2009-08-18 | Exp: 2029-08-13

70/10010975168Grant: 2021-04-13 | Exp: 2041-04-08

70/1009994610Grant: 2018-06-12 | Exp: 2038-06-07

70/10012421299Grant: 2025-09-23 | Exp: 2045-09-18

70/10010377793Grant: 2019-08-13 | Exp: 2039-08-08

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

Medicare Part B Spending

CMS physician-administered drug spending for Margenza (2024)

Total Spending

$5.3M

Total Claims

520

Beneficiaries

110

ASP Price

$47.61

Spending Trend

$2.3M(2021)→$5.9M(2022)→$5.4M(2023)→$5.3M(2024)

YoY Change:+4.6%

5yr CAGR:+2.7%

HCPCS: J9353 — Injection, margetuximab-cmkb, 5 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

Purple Book (Biologics)

BLA 761150

351(a) ReferenceLicensedCDERInjection

Proper Name

margetuximab-cmkb

Applicant

MacroGenics Inc.

Approval Date

December 16, 2020

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 21, 2025	SUPPL -11	View Letter (PDF)
May 26, 2023	SUPPL -5	View Letter (PDF)
Dec 21, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/10ML(25MG/ML)

▴

INJECTABLE;INJECTION | Approved: Dec. 16, 2020

No patent or exclusivity listings for this strength.