Viewing data from:

HUMIRA

BLA

ADALIMUMAB | B125057 | ABBVIE INC

2 products66 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 14, 2034(3056 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Apr. 28, 2029	Active	Computed
7-Year Orphan	Feb. 24, 2028	Active	Purple Book

Purple Book Patents (66)

Patent	Expiration	Status
11083792	Apr. 4, 2027	Active
11191834	Nov. 28, 2028	Active
11167030	Nov. 28, 2028	Active
8916153	Apr. 4, 2027	Active
9090689	Jul. 18, 2023	Expired
9090688	Apr. 26, 2032	Active
9085620	Jul. 18, 2023	Expired
9085619	Nov. 28, 2028	Active
9085618	Mar. 14, 2033	Active
9067992	Jul. 18, 2023	Expired
9062106	Apr. 26, 2032	Active
9061005	Apr. 11, 2025	Expired
8999337	Feb. 6, 2031	Active
8992926	Jun. 5, 2022	Expired
8986693	Apr. 11, 2025	Expired
8974790	Jun. 5, 2022	Expired
8961974	Apr. 11, 2025	Expired
8961973	Apr. 11, 2025	Expired
8926975	Jun. 8, 2027	Active
9957318	Apr. 26, 2032	Active
8911964	Sep. 13, 2027	Active
8911737	Jun. 5, 2022	Expired
8906646	Sep. 13, 2027	Active
8906373	Jul. 18, 2023	Expired
8906372	Apr. 4, 2027	Active
8895009	Apr. 4, 2027	Active
8889136	Oct. 9, 2027	Active
8883156	Apr. 4, 2027	Active
8808700	May. 16, 2026	Expired
8715664	Jul. 24, 2027	Active
8708968	Jan. 24, 2032	Active
8663945	Sep. 13, 2027	Active
8420081	Jan. 13, 2030	Active
8231876	Apr. 4, 2027	Active
6805686	May. 6, 2023	Expired
9096666	Apr. 4, 2027	Active
9090867	Sep. 13, 2027	Active
9913902	Apr. 4, 2027	Active
9708400	Mar. 14, 2033	Active
9683033	Apr. 26, 2032	Active
9669093	Jun. 10, 2028	Active
9624295	Mar. 31, 2031	Active
9550826	Nov. 14, 2034	Active
9546212	Jun. 5, 2022	Expired
9522953	Apr. 26, 2032	Active
9512216	Apr. 11, 2025	Expired
9505834	Apr. 26, 2032	Active
9499616	Mar. 14, 2033	Active
9499614	Mar. 14, 2034	Active
9359434	Mar. 14, 2033	Active
9346879	Mar. 14, 2033	Active
9334319	Mar. 14, 2033	Active
9339610	Jan. 24, 2032	Active
9102723	Apr. 4, 2027	Active
9150645	May. 13, 2033	Active
9181337	Mar. 14, 2033	Active
9181572	Mar. 14, 2033	Active
9187559	Apr. 11, 2025	Expired
9234032	Sep. 13, 2027	Active
9273132	Apr. 4, 2027	Active
9284370	Jun. 10, 2028	Active
9284371	Sep. 13, 2027	Active
9290568	Mar. 14, 2033	Active
9315574	Apr. 21, 2033	Active
9328165	Apr. 4, 2027	Active
9266949	May. 13, 2033	Active

Discovered Patents

View all 192 patents →

Top 50 of 192 AI-discovered patents by relevance.

Composition

(3)

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

92/1009315573Grant: 2016-04-19 | Exp: 2036-04-14

92/1009181337Grant: 2015-11-10 | Exp: 2035-11-05

Formulation

(22)

98/1008802101Grant: 2014-08-12 | Exp: 2034-08-07

95/1008802102Grant: 2014-08-12 | Exp: 2034-08-07

95/1008916153Grant: 2014-12-23 | Exp: 2034-12-18

95/1008916158Grant: 2014-12-23 | Exp: 2034-12-18

95/1009950066Grant: 2018-04-24 | Exp: 2038-04-19

95/1009085619Grant: 2015-07-21 | Exp: 2035-07-16

95/1009289497Grant: 2016-03-22 | Exp: 2036-03-17

95/1009220781Grant: 2015-12-29 | Exp: 2035-12-24

95/1009738714Grant: 2017-08-22 | Exp: 2037-08-17

95/1008932591Grant: 2015-01-13 | Exp: 2035-01-08

95/1008916157Grant: 2014-12-23 | Exp: 2034-12-18

95/1008821865Grant: 2014-09-02 | Exp: 2034-08-28

95/1009295725Grant: 2016-03-29 | Exp: 2036-03-24

94/1009522953Grant: 2016-12-20 | Exp: 2036-12-15

94/1009114166Grant: 2015-08-25 | Exp: 2035-08-20

92/1009334319Grant: 2016-05-10 | Exp: 2036-05-05

92/1009610301Grant: 2017-04-04 | Exp: 2037-03-30

92/1008802100Grant: 2014-08-12 | Exp: 2034-08-07

92/1009096666Grant: 2015-08-04 | Exp: 2035-07-30

92/1009272042Grant: 2016-03-01 | Exp: 2036-02-25

92/10011167030Grant: 2021-11-09 | Exp: 2041-11-04

92/1008216583Grant: 2012-07-10 | Exp: 2032-07-05

Method of Use

(14)

95/1009067992Grant: 2015-06-30 | Exp: 2035-06-25

95/1009399061Grant: 2016-07-26 | Exp: 2036-07-21

95/1009085620Grant: 2015-07-21 | Exp: 2035-07-16

95/1008986693Grant: 2015-03-24 | Exp: 2035-03-19

95/1009187559Grant: 2015-11-17 | Exp: 2035-11-12

95/1008889136Grant: 2014-11-18 | Exp: 2034-11-13

95/1009605064Grant: 2017-03-28 | Exp: 2037-03-23

94/1008715664Grant: 2014-05-06 | Exp: 2034-05-01

93/1009669093Grant: 2017-06-06 | Exp: 2037-06-01

92/1009334320Grant: 2016-05-10 | Exp: 2036-05-05

92/1009090689Grant: 2015-07-28 | Exp: 2035-07-23

92/1009061005Grant: 2015-06-23 | Exp: 2035-06-18

92/1009284370Grant: 2016-03-15 | Exp: 2036-03-10

92/1009512216Grant: 2016-12-06 | Exp: 2036-12-01

Manufacturing

(11)

96/1009365645Grant: 2016-06-14 | Exp: 2036-06-09

95/1008911964Grant: 2014-12-16 | Exp: 2034-12-11

95/1009284371Grant: 2016-03-15 | Exp: 2036-03-10

95/1008906646Grant: 2014-12-09 | Exp: 2034-12-04

92/1009193787Grant: 2015-11-24 | Exp: 2035-11-19

92/1009708400Grant: 2017-07-18 | Exp: 2037-07-13

92/1009181572Grant: 2015-11-10 | Exp: 2035-11-05

92/1009073988Grant: 2015-07-07 | Exp: 2035-07-02

92/1009683033Grant: 2017-06-20 | Exp: 2037-06-15

92/1009255143Grant: 2016-02-09 | Exp: 2036-02-04

92/1009234032Grant: 2016-01-12 | Exp: 2036-01-07

PTAB Proceedings

13 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2017-02106	9067992	IPR	Sandoz Inc.	Terminated-Settled	2017-09-14	—
IPR2017-00827	9085619	IPR	Coherus BioSciences Inc.	Terminated	2017-01-31	—
IPR2017-00823	9085619	IPR	Coherus BioSciences, Inc.	Institution Denied	2017-01-31	—
IPR2017-00822	9085619	IPR	Coherus BioSciences, Inc.	Institution Denied	2017-01-31	—
IPR2017-00826	9085619	IPR	Coherus BioSciences, Inc.	Terminated	2017-01-31	—
IPR2017-02105	9090689	IPR	Sandoz Inc.	Terminated-Settled	2017-09-14	—
IPR2018-00002	9512216	IPR	Sandoz Inc.	Institution Denied	2017-10-02	—
IPR2017-01008	9085619	IPR	Coherus BioSciences, Inc.	Institution Denied	2017-03-02	—
IPR2017-01009	9085619	IPR	Coherus BioSciences, Inc.	Institution Denied	2017-03-02	—
IPR2017-01824	9512216	IPR	Sandoz Inc.	Institution Denied	2017-07-20	—
IPR2017-01987	8911737	IPR	Sandoz Inc.	Institution Denied	2017-08-21	—
IPR2017-01988	8974790	IPR	Sandoz Inc.	Institution Denied	2017-08-21	—
IPR2018-00156	9187559	IPR	Sandoz Inc.	Institution Denied	2017-11-06	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

5 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. et al v. Alvotech hf. 1:2021cv02899 66 patentsadalimumab	N.D. Ill.	2021-05-28	Terminated 2022-03-09	—
Alvotech USA Inc. et al v. Abbvie Inc et al 2:2021cv00265 4 patentsadalimumab	VAED	2021-05-11	Terminated 2021-10-22	—
AbbVie Inc. et al v. Alvotech hf. 1:2021cv02258 62 patentsadalimumab	N.D. Ill.	2021-04-27	Terminated 2022-03-09	—
ABBVIE INC. et al v. SANDOZ INC. et al 3:2018cv12668 2 patentsadalimumab	D.N.J.	2018-08-10	Terminated 2018-10-16	—
AbbVie Inc. et al v. Amgen Inc. et al 1:2016cv00666 61 patentsadalimumab	D. Del.	2016-08-04	Terminated 2017-09-28	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 125057 | 11 presentations | 66 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

adalimumab

Applicant

AbbVie Inc.

Approval Date

31-Dec-02

Orphan Exclusivity

24-Feb-28

1y 7mo remaining

Listed Patents

Patent Number	Expiration
11083792	April 4, 2027
11191834	November 28, 2028
11167030	November 28, 2028
8916153	April 4, 2027
9090689	July 18, 2023
9090688	April 26, 2032
9085620	July 18, 2023
9085619	November 28, 2028
9085618	March 14, 2033
9067992	July 18, 2023
9062106	April 26, 2032
9061005	April 11, 2025
8999337	February 6, 2031
8992926	June 5, 2022
8986693	April 11, 2025
8974790	June 5, 2022
8961974	April 11, 2025
8961973	April 11, 2025
8926975	June 8, 2027
9957318	April 26, 2032
8911964	September 13, 2027
8911737	June 5, 2022
8906646	September 13, 2027
8906373	July 18, 2023
8906372	April 4, 2027
8895009	April 4, 2027
8889136	October 9, 2027
8883156	April 4, 2027
8808700	May 16, 2026
8715664	July 24, 2027
8708968	January 24, 2032
8663945	September 13, 2027
8420081	January 13, 2030
8231876	April 4, 2027
6805686	May 6, 2023
9096666	April 4, 2027
9090867	September 13, 2027
9913902	April 4, 2027
9708400	March 14, 2033
9683033	April 26, 2032
9669093	June 10, 2028
9624295	March 31, 2031
9550826	November 14, 2034
9546212	June 5, 2022
9522953	April 26, 2032
9512216	April 11, 2025
9505834	April 26, 2032
9499616	March 14, 2033
9499614	March 14, 2034
9359434	March 14, 2033
9346879	March 14, 2033
9334319	March 14, 2033
9339610	January 24, 2032
9102723	April 4, 2027
9150645	May 13, 2033
9181337	March 14, 2033
9181572	March 14, 2033
9187559	April 11, 2025
9234032	September 13, 2027
9273132	April 4, 2027
9284370	June 10, 2028
9284371	September 13, 2027
9290568	March 14, 2033
9315574	April 21, 2033
9328165	April 4, 2027
9266949	May 13, 2033

Presentations

40MG/0.8ML — Autoinjector (Subcutaneous)

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

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

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

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

40MG/0.8ML — Single-Dose Vial (Subcutaneous)

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

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

40MG/0.4ML — Autoinjector (Subcutaneous)

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

80MG/0.8ML — Autoinjector (Subcutaneous)

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

Approval Letters

50 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2025	SUPPL -425	View Letter (PDF)
Jul 17, 2025	SUPPL -424	View Letter (PDF)
Nov 6, 2023	SUPPL -423	View Letter (PDF)
Feb 25, 2021	SUPPL -417	View Letter (PDF)
Dec 21, 2020	SUPPL -419	View Letter (PDF)
Dec 21, 2020	SUPPL -418	View Letter (PDF)
Mar 12, 2020	SUPPL -415	View Letter (PDF)
Jan 18, 2019	SUPPL -411	View Letter (PDF)
Dec 7, 2018	SUPPL -410	View Letter (PDF)
Oct 17, 2018	SUPPL -409	View Letter (PDF)
Oct 1, 2018	SUPPL -408	View Letter (PDF)
Aug 3, 2018	SUPPL -406	View Letter (PDF)
Dec 15, 2017	SUPPL -403	View Letter (PDF)
May 2, 2017	SUPPL -402	View Letter (PDF)
Mar 29, 2017	SUPPL -399	View Letter (PDF)
Jul 1, 2016	SUPPL -397	View Letter (PDF)
Nov 24, 2015	SUPPL -394	View Letter (PDF)
Sep 14, 2015	SUPPL -393	View Letter (PDF)
Jan 8, 2015	SUPPL -280	View Letter (PDF)
Oct 2, 2014	SUPPL -367	View Letter (PDF)
Sep 25, 2014	SUPPL -356	View Letter (PDF)
Jun 3, 2014	SUPPL -366	View Letter (PDF)
May 20, 2014	SUPPL -368	View Letter (PDF)
Feb 27, 2014	SUPPL -355	View Letter (PDF)
Sep 20, 2013	SUPPL -327	View Letter (PDF)
May 15, 2013	SUPPL -310	View Letter (PDF)
Oct 3, 2012	SUPPL -232	View Letter (PDF)
May 30, 2012	SUPPL -278	View Letter (PDF)
Jan 5, 2012	SUPPL -271	View Letter (PDF)
Jan 5, 2012	SUPPL -254	View Letter (PDF)
Jan 5, 2012	SUPPL -276	View Letter (PDF)
Sep 13, 2011	SUPPL -255	View Letter (PDF)
Mar 25, 2011	SUPPL -128	View Letter (PDF)
Oct 19, 2010	SUPPL -224	View Letter (PDF)
Aug 3, 2010	SUPPL -213	View Letter (PDF)
Jun 17, 2010	SUPPL -161	View Letter (PDF)
Dec 3, 2009	SUPPL -196	View Letter (PDF)
Feb 26, 2008	SUPPL -114	View Letter (PDF)
Jan 25, 2008	SUPPL -110	View Letter (PDF)
Sep 7, 2007	SUPPL -108	View Letter (PDF)
Aug 1, 2007	SUPPL -94	View Letter (PDF)
Mar 6, 2007	SUPPL -89	View Letter (PDF)
Feb 23, 2007	SUPPL -60	View Letter (PDF)
Nov 14, 2006	SUPPL -71	View Letter (PDF)
Nov 14, 2006	SUPPL -95	View Letter (PDF)
Oct 20, 2005	SUPPL -46	View Letter (PDF)
Oct 20, 2005	SUPPL -45	View Letter (PDF)
Aug 6, 2004	SUPPL -16	View Letter (PDF)
Jul 7, 2004	SUPPL -23	View Letter (PDF)
Mar 16, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG/0.8ML

▴

SYRINGE | Approved: 2002-12-31 00:00:00

No patent or exclusivity listings for this strength.

#002 — 40MG/0.8ML

▾

VIAL | Approved: 2002-12-31 00:00:00