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SIMPONI

BLA

GOLIMUMAB | B125289 | CENTOCOR ORTHO BIOTECH INC

1 product14 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

May 3, 2039(4687 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 15, 2025	Expired	Computed

Purple Book Patents (14)

Patent	Expiration	Status
9487810	Mar. 14, 2033	Active
8017325	Jan. 13, 2029	Active
8852889	Jul. 6, 2032	Active
8956830	Mar. 14, 2033	Active
9170249	Mar. 12, 2032	Active
9217168	Mar. 14, 2033	Active
9663810	Mar. 14, 2033	Active
9890410	Mar. 12, 2032	Active
10421986	Aug. 8, 2035	Active
10500348	Nov. 20, 2031	Active
11225516	May. 3, 2039	Active
11633546	Nov. 8, 2032	Active
12139735	Jul. 6, 2032	Active
9475858	Jul. 6, 2032	Active

Discovered Patents

View all 45 patents →

45 AI-discovered patents, sorted by relevance.

Composition

(20)

95/1007160543Grant: 2007-01-09 | Exp: 2027-01-04

90/1006835823Grant: 2004-12-28 | Exp: 2024-12-23

88/1007070775Grant: 2006-07-04 | Exp: 2026-06-29

85/1007179893Grant: 2007-02-20 | Exp: 2027-02-15

85/1007744885Grant: 2010-06-29 | Exp: 2030-06-24

85/1007160995Grant: 2007-01-09 | Exp: 2027-01-04

85/1008617894Grant: 2013-12-31 | Exp: 2033-12-26

85/1006790444Grant: 2004-09-14 | Exp: 2024-09-09

72/1008415291Grant: 2013-04-09 | Exp: 2033-04-04

72/1007101674Grant: 2006-09-05 | Exp: 2026-08-31

70/1008975040Grant: 2015-03-10 | Exp: 2035-03-05

70/10011359029Grant: 2022-06-14 | Exp: 2042-06-09

65/10011192951Grant: 2021-12-07 | Exp: 2041-12-02

50/10011078263Grant: 2021-08-03 | Exp: 2041-07-29

50/10010053513Grant: 2018-08-21 | Exp: 2038-08-16

50/10011220531Grant: 2022-01-11 | Exp: 2042-01-06

50/10011124573Grant: 2021-09-21 | Exp: 2041-09-16

50/10012227593Grant: 2025-02-18 | Exp: 2045-02-13

50/10011149094Grant: 2021-10-19 | Exp: 2041-10-14

50/1008921524Grant: 2014-12-30 | Exp: 2034-12-25

Formulation

(3)

87/10011998643Grant: 2024-06-04 | Exp: 2044-05-30

75/1009072668Grant: 2015-07-07 | Exp: 2035-07-02

65/10012303483Grant: 2025-05-20 | Exp: 2045-05-15

Method of Use

(9)

95/1007179466Grant: 2007-02-20 | Exp: 2027-02-15

95/1007416729Grant: 2008-08-26 | Exp: 2028-08-21

92/1007214376Grant: 2007-05-08 | Exp: 2027-05-03

90/10010918737Grant: 2021-02-16 | Exp: 2041-02-11

90/1007160542Grant: 2007-01-09 | Exp: 2027-01-04

88/10012258393Grant: 2025-03-25 | Exp: 2045-03-20

85/1007166284Grant: 2007-01-23 | Exp: 2027-01-18

85/10011780911Grant: 2023-10-10 | Exp: 2043-10-05

50/1008580714Grant: 2013-11-12 | Exp: 2033-11-07

Manufacturing

(5)

88/10012018075Grant: 2024-06-25 | Exp: 2044-06-20

65/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

55/1008361474Grant: 2013-01-29 | Exp: 2033-01-24

55/10012084475Grant: 2024-09-10 | Exp: 2044-09-05

55/1008980626Grant: 2015-03-17 | Exp: 2035-03-12

Device

(4)

60/10011724035Grant: 2023-08-15 | Exp: 2043-08-10

55/10010603428Grant: 2020-03-31 | Exp: 2040-03-26

55/10011123492Grant: 2021-09-21 | Exp: 2041-09-16

50/1009757520Grant: 2017-09-12 | Exp: 2037-09-07

Diagnostic

(4)

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

68/10011674951Grant: 2023-06-13 | Exp: 2043-06-08

65/10010429379Grant: 2019-10-01 | Exp: 2039-09-26

60/10011946939Grant: 2024-04-02 | Exp: 2044-03-28

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 125289 | 4 presentations | 14 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

golimumab

Applicant

Janssen Biotech, Inc.

Approval Date

24-Apr-09

Listed Patents

Patent Number	Expiration
9487810	March 14, 2033
8017325	January 13, 2029
8852889	July 6, 2032
8956830	March 14, 2033
9170249	March 12, 2032
9217168	March 14, 2033
9663810	March 14, 2033
9890410	March 12, 2032
10421986	August 8, 2035
10500348	November 20, 2031
11225516	May 3, 2039
11633546	November 8, 2032
12139735	July 6, 2032
9475858	July 6, 2032

Presentations

50MG/0.5ML — Autoinjector (Subcutaneous)

50MG/0.5ML — Pre-Filled Syringe (Subcutaneous)

100MG/ML — Autoinjector (Subcutaneous)

100MG/ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

32 letters from Drugs@FDA

Date	Submission	Document
Oct 23, 2025	SUPPL -158	View Letter (PDF)
Oct 7, 2025	SUPPL -157	View Letter (PDF)
Oct 3, 2025	SUPPL -156	View Letter (PDF)
Jul 11, 2025	SUPPL -155	View Letter (PDF)
Nov 17, 2023	SUPPL -153	View Letter (PDF)
Mar 31, 2023	SUPPL -150	View Letter (PDF)
Sep 25, 2019	SUPPL -146	View Letter (PDF)
Mar 12, 2018	SUPPL -139	View Letter (PDF)
Feb 9, 2018	SUPPL -141	View Letter (PDF)
Nov 15, 2017	SUPPL -137	View Letter (PDF)
Jun 22, 2017	SUPPL -133	View Letter (PDF)
Jan 31, 2017	SUPPL -135	View Letter (PDF)
Jan 11, 2016	SUPPL -127	View Letter (PDF)
Jun 18, 2015	SUPPL -124	View Letter (PDF)
Dec 23, 2014	SUPPL -121	View Letter (PDF)
Dec 31, 2013	SUPPL -103	View Letter (PDF)
Nov 14, 2013	SUPPL -94	View Letter (PDF)
May 16, 2013	SUPPL -78	View Letter (PDF)
May 16, 2013	SUPPL -79	View Letter (PDF)
May 16, 2013	SUPPL -77	View Letter (PDF)
May 8, 2013	SUPPL -86	View Letter (PDF)
Apr 30, 2013	SUPPL -84	View Letter (PDF)
Nov 26, 2012	SUPPL -70	View Letter (PDF)
Jan 24, 2012	SUPPL -38	View Letter (PDF)
Jan 3, 2012	SUPPL -64	View Letter (PDF)
Sep 13, 2011	SUPPL -53	View Letter (PDF)
Mar 25, 2011	SUPPL -20	View Letter (PDF)
Jan 6, 2011	SUPPL -29	View Letter (PDF)
Oct 19, 2010	SUPPL -33	View Letter (PDF)
Aug 3, 2010	SUPPL -25	View Letter (PDF)
Nov 25, 2009	SUPPL -6	View Letter (PDF)
May 6, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

▴

INJECTABLE; INJECTION | Approved: 2009-04-24 00:00:00

No patent or exclusivity listings for this strength.