Viewing data from:

AMJEVITA

Interchangeable Biosimilar

ADALIMUMAB-ATTO | B761024 | AMGEN INC

2 products0 Purple Book patents9 biosimilars

Biologic LOEBiosimilar competition

9 approved biosimilars

September 23, 2028(813 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 23, 2028	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

AmjevitaBLA 761024ICAmjevitaBLA 761024ICAmjevitaBLA 761024ICAmjevitaBLA 761024ICAmjevitaBLA 761024ICAmjevitaBLA 761024ICAmjevitaBLA 761024ICAmjevitaBLA 761024ICAmjevitaBLA 761024IC

Discovered Patents

View all 109 patents →

Top 50 of 109 AI-discovered patents by relevance.

Composition

(21)

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

95/1007282483Grant: 2007-10-16 | Exp: 2027-10-11

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

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

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

85/1006417158Grant: 2002-07-09 | Exp: 2022-07-04

80/1006838550Grant: 2005-01-04 | Exp: 2024-12-30

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

75/1006552170Grant: 2003-04-22 | Exp: 2023-04-17

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

72/1008198410Grant: 2012-06-12 | Exp: 2032-06-07

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

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

70/1009200060Grant: 2015-12-01 | Exp: 2035-11-26

70/1009855343Grant: 2018-01-02 | Exp: 2037-12-28

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

68/10010829551Grant: 2020-11-10 | Exp: 2040-11-05

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

65/10011198732Grant: 2021-12-14 | Exp: 2041-12-09

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

65/10010208122Grant: 2019-02-19 | Exp: 2039-02-14

Formulation

(6)

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

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

70/1009352043Grant: 2016-05-31 | Exp: 2036-05-26

70/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

68/10012178873Grant: 2024-12-31 | Exp: 2044-12-26

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

Manufacturing

(18)

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

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

75/10011312745Grant: 2022-04-26 | Exp: 2042-04-21

72/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

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

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

70/1007795494Grant: 2010-09-14 | Exp: 2030-09-09

70/10010167492Grant: 2019-01-01 | Exp: 2038-12-27

70/1007781395Grant: 2010-08-24 | Exp: 2030-08-19

68/1008491904Grant: 2013-07-23 | Exp: 2033-07-18

68/1009598667Grant: 2017-03-21 | Exp: 2037-03-16

65/1008895709Grant: 2014-11-25 | Exp: 2034-11-20

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

65/1006657103Grant: 2003-12-02 | Exp: 2023-11-27

65/1009359435Grant: 2016-06-07 | Exp: 2036-06-02

65/10010513723Grant: 2019-12-24 | Exp: 2039-12-19

65/1008217153Grant: 2012-07-10 | Exp: 2032-07-05

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

Device

(5)

70/10010183117Grant: 2019-01-22 | Exp: 2039-01-17

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

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

65/1009821117Grant: 2017-11-21 | Exp: 2037-11-16

60/10012290666Grant: 2025-05-06 | Exp: 2045-05-01

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 761024 | 9 presentations

InterchangeableLicensedCDERInjection

Proper Name

adalimumab-atto

Applicant

Amgen Inc.

Approval Date

23-Sep-16

Reference Product: Humira — adalimumab

Presentations

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

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

40MG/0.8ML — Autoinjector (Subcutaneous)

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

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

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

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

40MG/0.4ML — Autoinjector (Subcutaneous)

80MG/0.8ML — Autoinjector (Subcutaneous)

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Oct 20, 2025	SUPPL -26	View Letter (PDF)
Sep 18, 2025	SUPPL -22	View Letter (PDF)
May 21, 2025	SUPPL -21	View Letter (PDF)
Apr 9, 2025	SUPPL -23	View Letter (PDF)
Aug 21, 2024	SUPPL -19	View Letter (PDF)
Aug 15, 2023	SUPPL -15	View Letter (PDF)
Jul 13, 2023	SUPPL -17	View Letter (PDF)
Apr 7, 2023	SUPPL -11	View Letter (PDF)
Mar 23, 2023	SUPPL -12	View Letter (PDF)
Jul 29, 2022	SUPPL -10	View Letter (PDF)
Jun 17, 2019	SUPPL -4	View Letter (PDF)
Mar 20, 2018	SUPPL -3	View Letter (PDF)
Sep 26, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG/0.4ML

▴

INJECTABLE;INJECTION | Approved: 2016-09-23 00:00:00

No patent or exclusivity listings for this strength.

#002 — 40MG/0.8ML

▾

INJECTABLE;INJECTION | Approved: 2016-09-23 00:00:00