Viewing data from:

HYRIMOZ

Interchangeable Biosimilar

ADALIMUMAB-ADAZ | B761071 | SANDOZ INC

1 product0 Purple Book patents10 biosimilars

Biologic LOEBiosimilar competition

10 approved biosimilars

October 30, 2030(1580 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Oct. 30, 2030	Active	Computed
1-Year Interchangeable	Apr. 5, 2025	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Nov. 28, 20446723 days remaining

Based on latest discovered patent 12157767(manufacturing) · relevance 55/100

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

Approved Biosimilars

HyrimozBLA 761071ICHyrimozBLA 761071ICHyrimozBLA 761071ICHyrimozBLA 761071ICHyrimozBLA 761071ICHyrimozBLA 761071ICHyrimozBLA 761071ICHyrimozBLA 761071ICHyrimozBLA 761071ICHyrimozBLA 761071IC

Discovered Patents

View all 76 patents →

Top 50 of 76 AI-discovered patents by relevance.

Composition

(13)

95/1008877194Grant: 2014-11-04 | Exp: 2034-10-30

92/1009803009Grant: 2017-10-31 | Exp: 2037-10-26

75/10010647756Grant: 2020-05-12 | Exp: 2040-05-07

72/1009434748Grant: 2016-09-06 | Exp: 2036-09-01

60/10010793635Grant: 2020-10-06 | Exp: 2040-10-01

55/10011578428Grant: 2023-02-14 | Exp: 2043-02-09

55/1008303955Grant: 2012-11-06 | Exp: 2032-11-01

55/1009701752Grant: 2017-07-11 | Exp: 2037-07-06

52/10010933112Grant: 2021-03-02 | Exp: 2041-02-25

52/10010792372Grant: 2020-10-06 | Exp: 2040-10-01

50/10011510959Grant: 2022-11-29 | Exp: 2042-11-24

50/10010941216Grant: 2021-03-09 | Exp: 2041-03-04

50/1008609105Grant: 2013-12-17 | Exp: 2033-12-12

Formulation

(7)

70/1007758860Grant: 2010-07-20 | Exp: 2030-07-15

65/1007608278Grant: 2009-10-27 | Exp: 2029-10-22

65/1008318164Grant: 2012-11-27 | Exp: 2032-11-22

65/1007744890Grant: 2010-06-29 | Exp: 2030-06-24

55/10010188600Grant: 2019-01-29 | Exp: 2039-01-24

55/1008871201Grant: 2014-10-28 | Exp: 2034-10-23

52/1007906109Grant: 2011-03-15 | Exp: 2031-03-10

Method of Use

(3)

85/1007379820Grant: 2008-05-27 | Exp: 2028-05-22

72/1009618507Grant: 2017-04-11 | Exp: 2037-04-06

65/1009550986Grant: 2017-01-24 | Exp: 2037-01-19

Manufacturing

(24)

75/1009469672Grant: 2016-10-18 | Exp: 2036-10-13

72/1008993326Grant: 2015-03-31 | Exp: 2035-03-26

70/10010443035Grant: 2019-10-15 | Exp: 2039-10-10

70/1008895709Grant: 2014-11-25 | Exp: 2034-11-20

68/1008350013Grant: 2013-01-08 | Exp: 2033-01-03

65/1009975948Grant: 2018-05-22 | Exp: 2038-05-17

65/1008163551Grant: 2012-04-24 | Exp: 2032-04-19

65/1007247475Grant: 2007-07-24 | Exp: 2027-07-19

65/1008574907Grant: 2013-11-05 | Exp: 2033-10-31

58/1009598667Grant: 2017-03-21 | Exp: 2037-03-16

55/1008058407Grant: 2011-11-15 | Exp: 2031-11-10

55/1009816069Grant: 2017-11-14 | Exp: 2037-11-09

55/1009895497Grant: 2018-02-20 | Exp: 2038-02-15

55/1009359617Grant: 2016-06-07 | Exp: 2036-06-02

55/10012157767Grant: 2024-12-03 | Exp: 2044-11-28

55/1008633139Grant: 2014-01-21 | Exp: 2034-01-16

55/1007514237Grant: 2009-04-07 | Exp: 2029-04-02

55/10010913984Grant: 2021-02-09 | Exp: 2041-02-04

55/10011612666Grant: 2023-03-28 | Exp: 2043-03-23

52/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

52/10011667696Grant: 2023-06-06 | Exp: 2043-06-01

50/1008491904Grant: 2013-07-23 | Exp: 2033-07-18

50/1007714111Grant: 2010-05-11 | Exp: 2030-05-06

50/10010494348Grant: 2019-12-03 | Exp: 2039-11-28

Device

(2)

75/10010183117Grant: 2019-01-22 | Exp: 2039-01-17

70/1009821117Grant: 2017-11-21 | Exp: 2037-11-16

Diagnostic

(1)

75/10011779643Grant: 2023-10-10 | Exp: 2043-10-05

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 761071 | 10 presentations

InterchangeableLicensedCDERInjection

Proper Name

adalimumab-adaz

Applicant

Sandoz Inc.

Approval Date

30-Oct-18

Reference Product: Humira — adalimumab

Presentations

40MG/0.8ML — Pre-Filled Syringe (Subcutaneous)

20MG/0.2ML — Pre-Filled Syringe (Subcutaneous)

40MG/0.8ML — Autoinjector (Subcutaneous)

10MG/0.2ML — Pre-Filled Syringe (Subcutaneous)

40MG/0.4ML — Autoinjector (Subcutaneous)

80MG/0.8ML — Autoinjector (Subcutaneous)

20MG/0.4ML — Pre-Filled Syringe (Subcutaneous)

40MG/0.4ML — Pre-Filled Syringe (Subcutaneous)

80MG/0.8ML — Pre-Filled Syringe (Subcutaneous)

10MG/0.1ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Oct 20, 2025	SUPPL -31	View Letter (PDF)
Jul 31, 2025	SUPPL -24	View Letter (PDF)
May 21, 2025	SUPPL -22	View Letter (PDF)
Jun 13, 2024	SUPPL -21	View Letter (PDF)
Apr 8, 2024	SUPPL -19	View Letter (PDF)
Sep 11, 2023	SUPPL -16	View Letter (PDF)
Apr 17, 2023	SUPPL -15	View Letter (PDF)
Mar 23, 2023	SUPPL -14	View Letter (PDF)
Jul 19, 2022	SUPPL -12	View Letter (PDF)
Jul 19, 2022	SUPPL -10	View Letter (PDF)
Mar 29, 2022	SUPPL -11	View Letter (PDF)
Feb 25, 2021	SUPPL -1	View Letter (PDF)
Feb 28, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/0.8ML

▴

INJECTABLE;INJECTION | Approved: 2018-10-30 00:00:00

No patent or exclusivity listings for this strength.