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ACTEMRA

BLA

TOCILIZUMAB | B125276 | GENENTECH

3 products35 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

July 31, 2035(3191 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Feb. 28, 2025	Expired	Purple Book

Purple Book Patents (35)

Patent	Expiration	Status
10017732	Dec. 25, 2034	Active
10231981	Dec. 3, 2031	Active
10336983	Jul. 31, 2035	Active
10501769	Oct. 25, 2030	Active
10590164	Mar. 19, 2033	Active
10662237	Aug. 7, 2031	Active
10676710	Mar. 14, 2034	Active
10744201	Apr. 28, 2024	Expired
10829732	Mar. 14, 2034	Active
10874677	Mar. 2, 2032	Active
10982003	Aug. 6, 2030	Active
11008394	Dec. 26, 2028	Active
11021728	Oct. 25, 2030	Active
11078294	Jul. 8, 2028	Active
11136375	Jul. 19, 2029	Active
11136610	Oct. 25, 2030	Active
11359026	Dec. 26, 2028	Active
11377678	Oct. 25, 2030	Active
11584798	Dec. 26, 2028	Active
11667720	Nov. 7, 2031	Active
7332289	Aug. 4, 2023	Expired
7521052	Apr. 28, 2024	Expired
8398980	Feb. 25, 2028	Active
8512983	Jan. 4, 2031	Active
8568720	Nov. 5, 2029	Active
8574869	Jul. 8, 2028	Active
8580264	Nov. 7, 2031	Active
8617550	Mar. 3, 2026	Expired
8709409	Jun. 22, 2024	Expired
8734800	Mar. 24, 2025	Expired
9539263	May. 23, 2032	Active
9630988	Jun. 13, 2033	Active
9714293	Aug. 6, 2030	Active
9750752	Aug. 30, 2032	Active
9902777	May. 28, 2025	Expired

PTAB Proceedings

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

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2022-01065	10231981	IPR	Fresenius Kabi USA, LLC	Terminated-Settled	2022-06-07	—
IPR2021-01025	10744201	IPR	Fresenius Kabi USA, LLC	Terminated-Settled	2021-06-28	—
IPR2022-00579	10874677	IPR	Celltrion, Inc. et al.	Final Written Decision	2022-02-21	2024-03-07
IPR2021-01336	10874677	IPR	Fresenius Kabi USA, LLC	Terminated-Settled	2021-08-18	2022-10-17
IPR2017-01357	7332289	IPR	Pfizer, Inc.	Final Written Decision	2017-05-19	—
IPR2021-01024	7521052	IPR	Fresenius Kabi USA, LLC	Terminated-Settled	2021-06-28	—
IPR2022-00578	8580264	IPR	Celltrion, Inc. et al.	Final Written Decision	2022-02-21	2024-03-07
IPR2021-01542	8580264	IPR	Fresenius Kabi USA, LLC	Terminated-Settled	2021-09-24	2022-10-17
IPR2021-01288	8580264	IPR	Fresenius Kabi USA, LLC	Terminated-Settled	2021-08-18	2022-10-17
IPR2022-00201	9750752	IPR	Fresenius Kabi USA, LLC	Terminated-Settled	2021-11-24	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Genentech, Inc. et al v. Biogen MA Inc. et al 1:2023cv11573 20 patentstocilizumab	D. Mass.	2023-07-13	Terminated 2023-10-23	—

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 125276 | 3 presentations | 35 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

tocilizumab

Applicant

Genentech, Inc.

Approval Date

January 8, 2010

Orphan Exclusivity

February 28, 2025

Expired

Listed Patents

Patent Number	Expiration
10017732	December 25, 2034
10231981	December 3, 2031
10336983	July 31, 2035
10501769	October 25, 2030
10590164	March 19, 2033
10662237	August 7, 2031
10676710	March 14, 2034
10744201	April 28, 2024
10829732	March 14, 2034
10874677	March 2, 2032
10982003	August 6, 2030
11008394	December 26, 2028
11021728	October 25, 2030
11078294	July 8, 2028
11136375	July 19, 2029
11136610	October 25, 2030
11359026	December 26, 2028
11377678	October 25, 2030
11584798	December 26, 2028
11667720	November 7, 2031
7332289	August 4, 2023
7521052	April 28, 2024
8398980	February 25, 2028
8512983	January 4, 2031
8568720	November 5, 2029
8574869	July 8, 2028
8580264	November 7, 2031
8617550	March 3, 2026
8709409	June 22, 2024
8734800	March 24, 2025
9539263	May 23, 2032
9630988	June 13, 2033
9714293	August 6, 2030
9750752	August 30, 2032
9902777	May 28, 2025

Presentations

80MG/4ML (20MG/ML) — Single-Dose Vial (Intravenous)

200MG/10ML (20MG/ML) — Single-Dose Vial (Intravenous)

400MG/20ML (20MG/ML) — Single-Dose Vial (Intravenous)

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

Approval Letters

34 letters from Drugs@FDA

Date	Submission	Document
Dec 11, 2025	SUPPL -147	View Letter (PDF)
Aug 12, 2025	SUPPL -149	View Letter (PDF)
Dec 11, 2024	SUPPL -146	View Letter (PDF)
Sep 20, 2024	SUPPL -148	View Letter (PDF)
Dec 22, 2022	SUPPL -138	View Letter (PDF)
Mar 1, 2022	SUPPL -134	View Letter (PDF)
Oct 25, 2021	SUPPL -135	View Letter (PDF)
Mar 8, 2021	SUPPL -131	View Letter (PDF)
Jun 1, 2020	SUPPL -129	View Letter (PDF)
Jun 12, 2019	SUPPL -127	View Letter (PDF)
Apr 15, 2019	SUPPL -121	View Letter (PDF)
Apr 15, 2019	SUPPL -120	View Letter (PDF)
Nov 20, 2018	SUPPL -118	View Letter (PDF)
Sep 14, 2018	SUPPL -122	View Letter (PDF)
May 21, 2018	SUPPL -117	View Letter (PDF)
May 16, 2018	SUPPL -115	View Letter (PDF)
Mar 28, 2018	SUPPL -116	View Letter (PDF)
Aug 31, 2017	SUPPL -114	View Letter (PDF)
May 24, 2017	SUPPL -112	View Letter (PDF)
Apr 3, 2017	SUPPL -111	View Letter (PDF)
Sep 26, 2016	SUPPL -107	View Letter (PDF)
Aug 21, 2015	SUPPL -106	View Letter (PDF)
Nov 14, 2014	SUPPL -105	View Letter (PDF)
Oct 22, 2013	SUPPL -92	View Letter (PDF)
Jul 5, 2013	SUPPL -75	View Letter (PDF)
May 1, 2013	SUPPL -64	View Letter (PDF)
Oct 15, 2012	SUPPL -49	View Letter (PDF)
Aug 15, 2012	SUPPL -46	View Letter (PDF)
Jun 22, 2012	SUPPL -48	View Letter (PDF)
May 26, 2011	SUPPL -22	View Letter (PDF)
May 26, 2011	SUPPL -23	View Letter (PDF)
Jan 7, 2011	SUPPL -11	View Letter (PDF)
Jan 7, 2011	SUPPL -10	View Letter (PDF)
Jan 26, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 80MG/4ML

▴

INJECTABLE; INJECTION | Approved: 2010-01-08 00:00:00

No patent or exclusivity listings for this strength.

#002 — 200MG/10ML

▾

INJECTABLE; INJECTION | Approved: 2010-01-08 00:00:00

#003 — 400MG/20ML

▾

INJECTABLE; INJECTION | Approved: 2010-01-08 00:00:00