Viewing data from:

YUSIMRY

Biosimilar

ADALIMUMAB-AQVH | B761216 | COHERUS BIOSCIENCES INC

1 product0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

December 17, 2033(2724 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 17, 2033	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 2, 20457031 days remaining

Based on latest discovered patent 12434015(device) · relevance 65/100

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

Approved Biosimilars

YusimryBLA 761216YusimryBLA 761216

Discovered Patents

View all 106 patents →

Top 50 of 106 AI-discovered patents by relevance.

Composition

(21)

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

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

92/1007282483Grant: 2007-10-16 | Exp: 2027-10-11

85/1007264944Grant: 2007-09-04 | Exp: 2027-08-30

85/1007820877Grant: 2010-10-26 | Exp: 2030-10-21

85/1006552170Grant: 2003-04-22 | Exp: 2023-04-17

75/1006417158Grant: 2002-07-09 | Exp: 2022-07-04

75/1006271346Grant: 2001-08-07 | Exp: 2021-08-02

75/10011198732Grant: 2021-12-14 | Exp: 2041-12-09

75/1009562108Grant: 2017-02-07 | Exp: 2037-02-02

72/1007435871Grant: 2008-10-14 | Exp: 2028-10-09

72/10011427627Grant: 2022-08-30 | Exp: 2042-08-25

70/1006221675Grant: 2001-04-24 | Exp: 2021-04-19

70/1008597615Grant: 2013-12-03 | Exp: 2033-11-28

65/10010829551Grant: 2020-11-10 | Exp: 2040-11-05

65/10011466078Grant: 2022-10-11 | Exp: 2042-10-06

65/1009308258Grant: 2016-04-12 | Exp: 2036-04-07

65/1007186810Grant: 2007-03-06 | Exp: 2027-03-01

65/10010640563Grant: 2020-05-05 | Exp: 2040-04-30

65/1008604174Grant: 2013-12-10 | Exp: 2033-12-05

60/1009562107Grant: 2017-02-07 | Exp: 2037-02-02

Formulation

(8)

95/10012247071Grant: 2025-03-11 | Exp: 2045-03-06

75/1008858935Grant: 2014-10-14 | Exp: 2034-10-09

75/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

75/1009352043Grant: 2016-05-31 | Exp: 2036-05-26

70/10012178873Grant: 2024-12-31 | Exp: 2044-12-26

65/10012318447Grant: 2025-06-03 | Exp: 2045-05-29

65/10010653781Grant: 2020-05-19 | Exp: 2040-05-14

65/1007956160Grant: 2011-06-07 | Exp: 2031-06-02

Manufacturing

(19)

85/1008809051Grant: 2014-08-19 | Exp: 2034-08-14

85/1007238776Grant: 2007-07-03 | Exp: 2027-06-28

80/10011312745Grant: 2022-04-26 | Exp: 2042-04-21

75/1006833268Grant: 2004-12-21 | Exp: 2024-12-16

75/1006657103Grant: 2003-12-02 | Exp: 2023-11-27

72/1006673986Grant: 2004-01-06 | Exp: 2024-01-01

70/1007547817Grant: 2009-06-16 | Exp: 2029-06-11

70/1009598667Grant: 2017-03-21 | Exp: 2037-03-16

70/10012344668Grant: 2025-07-01 | Exp: 2045-06-26

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

65/1008263750Grant: 2012-09-11 | Exp: 2032-09-06

65/10010167492Grant: 2019-01-01 | Exp: 2038-12-27

65/1009388447Grant: 2016-07-12 | Exp: 2036-07-07

65/10012325737Grant: 2025-06-10 | Exp: 2045-06-05

65/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

65/1007049426Grant: 2006-05-23 | Exp: 2026-05-18

65/1008491904Grant: 2013-07-23 | Exp: 2033-07-18

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

62/1007781395Grant: 2010-08-24 | Exp: 2030-08-19

Device

(2)

65/10012434015Grant: 2025-10-07 | Exp: 2045-10-02

65/10010646664Grant: 2020-05-12 | Exp: 2040-05-07

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 761216 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

adalimumab-aqvh

Applicant

Hong Kong King-Friend Industrial Company Limited

Approval Date

17-Dec-21

Reference Product: Humira — adalimumab

Presentations

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

40MG/0.8ML — Autoinjector (Subcutaneous)

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 13, 2025	SUPPL -7	View Letter (PDF)
Sep 14, 2023	SUPPL -4	View Letter (PDF)
Apr 3, 2023	SUPPL -3	View Letter (PDF)
Feb 28, 2023	SUPPL -1	View Letter (PDF)
Dec 21, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

▴

INJECTABLE;INJECTION | Approved: 2021-12-17 00:00:00

No patent or exclusivity listings for this strength.