Viewing data from:

RITUXAN

BLA

RITUXIMAB | B103705 | GENENTECH

2 products15 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	Dec. 2, 2028	Active	Purple Book

Purple Book Patents (15)

Patent	Expiration	Status
10017732	Mar. 14, 2034	Active
10336983	Jul. 31, 2035	Active
10450379	Nov. 14, 2026	Active
10654940	Nov. 14, 2026	Active
10662237	Aug. 7, 2031	Active
10676710	Mar. 14, 2034	Active
10759866	Jul. 8, 2028	Active
10829732	Mar. 14, 2034	Active
10982003	Aug. 6, 2030	Active
7485704	Mar. 8, 2025	Expired
7976838	Jun. 30, 2025	Expired
8460895	Aug. 8, 2029	Active
8512983	Jan. 4, 2031	Active
8574869	Jul. 8, 2028	Active
9714293	Aug. 6, 2030	Active

Discovered Patents

View all 384 patents →

Top 50 of 384 AI-discovered patents by relevance.

Composition

(17)

95/10012275797Grant: 2025-04-15 | Exp: 2045-04-10

95/1008057793Grant: 2011-11-15 | Exp: 2031-11-10

95/10012252549Grant: 2025-03-18 | Exp: 2045-03-13

94/1007435803Grant: 2008-10-14 | Exp: 2028-10-09

93/1008562992Grant: 2013-10-22 | Exp: 2033-10-17

92/1009045543Grant: 2015-06-02 | Exp: 2035-05-28

92/1009289470Grant: 2016-03-22 | Exp: 2036-03-17

90/1008287864Grant: 2012-10-16 | Exp: 2032-10-11

90/10011407841Grant: 2022-08-09 | Exp: 2042-08-04

90/10011168143Grant: 2021-11-09 | Exp: 2041-11-04

90/1008883980Grant: 2014-11-11 | Exp: 2034-11-06

90/1009873745Grant: 2018-01-23 | Exp: 2038-01-18

90/1008759503Grant: 2014-06-24 | Exp: 2034-06-19

89/10011155621Grant: 2021-10-26 | Exp: 2041-10-21

89/1008999324Grant: 2015-04-07 | Exp: 2035-04-02

88/10012195548Grant: 2025-01-14 | Exp: 2045-01-09

88/10010544220Grant: 2020-01-28 | Exp: 2040-01-23

Method of Use

(26)

96/1007976838Grant: 2011-07-12 | Exp: 2031-07-07

95/1009539263Grant: 2017-01-10 | Exp: 2037-01-05

95/1007820161Grant: 2010-10-26 | Exp: 2030-10-21

95/10010400043Grant: 2019-09-03 | Exp: 2039-08-29

95/1008557244Grant: 2013-10-15 | Exp: 2033-10-10

95/1008580264Grant: 2013-11-12 | Exp: 2033-11-07

94/10011000510Grant: 2021-05-11 | Exp: 2041-05-06

92/1008206711Grant: 2012-06-26 | Exp: 2032-06-21

92/10011840576Grant: 2023-12-12 | Exp: 2043-12-07

92/1006896885Grant: 2005-05-24 | Exp: 2025-05-19

92/10010113000Grant: 2018-10-30 | Exp: 2038-10-25

92/1009750752Grant: 2017-09-05 | Exp: 2037-08-31

92/1007837995Grant: 2010-11-23 | Exp: 2030-11-18

92/10010654940Grant: 2020-05-19 | Exp: 2040-05-14

92/100OB11413282Grant: 2022-08-16 | Exp: 2042-08-11

90/1008821873Grant: 2014-09-02 | Exp: 2034-08-28

90/1007708994Grant: 2010-05-04 | Exp: 2030-04-29

90/1009993550Grant: 2018-06-12 | Exp: 2038-06-07

90/100OB11590128Grant: 2023-02-28 | Exp: 2043-02-23

90/1007534772Grant: 2009-05-19 | Exp: 2029-05-14

89/10010450379Grant: 2019-10-22 | Exp: 2039-10-17

88/1009845504Grant: 2017-12-19 | Exp: 2037-12-14

88/10012195547Grant: 2025-01-14 | Exp: 2045-01-09

88/10012144859Grant: 2024-11-19 | Exp: 2044-11-14

88/1008329172Grant: 2012-12-11 | Exp: 2032-12-06

88/1008883155Grant: 2014-11-11 | Exp: 2034-11-06

Manufacturing

(1)

92/1009896478Grant: 2018-02-20 | Exp: 2038-02-15

Diagnostic

(6)

95/1007858300Grant: 2010-12-28 | Exp: 2030-12-23

95/10011686734Grant: 2023-06-27 | Exp: 2043-06-22

92/10010705095Grant: 2020-07-07 | Exp: 2040-07-02

90/1008871449Grant: 2014-10-28 | Exp: 2034-10-23

90/1009879325Grant: 2018-01-30 | Exp: 2038-01-25

88/1008124350Grant: 2012-02-28 | Exp: 2032-02-23

PTAB Proceedings

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

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2018-01019	7976838	IPR	Celltrion, Inc. et al.	Terminated	2018-05-04	—
IPR2017-02042	7976838	IPR	Sandoz Inc.	Institution Denied	2017-08-31	—
IPR2017-02036	7976838	IPR	Sandoz, Inc.	Institution Denied	2017-08-31	—
IPR2017-01923	7976838	IPR	Pfizer, Inc.	Final Written Decision	2017-08-29	—
IPR2016-01667	7976838	IPR	Celltrion Inc.	Institution Denied	2016-08-24	—
IPR2015-01733	7976838	IPR	Celltrion, Inc.	Institution Denied	2015-08-14	—
IPR2015-00417	7976838	IPR	Boehringer Ingelheim Pharmaceuticals, Inc.	Terminated-Settled	2014-12-15	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
GENENTECH, INC. et al v. CELLTRION, INC. et al 1:2018cv00574 40 patentsrituximab	D.N.J.	2018-01-12	Terminated 2018-11-01	—
Celltrion, Inc. et al v. Genentech, Inc. et al 4:2018cv00276 37 patentsrituximab	CAND	2018-01-11	Terminated 2018-06-11	—
GENENTECH, INC. et al v. SANDOZ, INC. et al 1:2017cv13507 24 patentsrituximab	D.N.J.	2017-12-21	Terminated 2018-12-07	—

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Korein Tillery LLC FDA-2006-P-0001 Korein Tillery LLC filed this citizen petition on February 24, 2006, requesting that the FDA stay approval of all pending supplements to biologics license applications for Rituxan (rituximab) submitted by Genentech and Biogen, particularly their application to market the drug for rheumatoid arthriti	505(q) Stay Request	2008-08-08	Denied	Korein Tillery LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 103705 | 2 presentations | 15 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

rituximab

Applicant

Genentech, Inc.

Approval Date

November 26, 1997

Orphan Exclusivity

December 2, 2028

2y remaining

Listed Patents

Patent Number	Expiration
10017732	March 14, 2034
10336983	July 31, 2035
10450379	November 14, 2026
10654940	November 14, 2026
10662237	August 7, 2031
10676710	March 14, 2034
10759866	July 8, 2028
10829732	March 14, 2034
10982003	August 6, 2030
7485704	March 8, 2025
7976838	June 30, 2025
8460895	August 8, 2029
8512983	January 4, 2031
8574869	July 8, 2028
9714293	August 6, 2030

Presentations

100MG/10ML (10MG/ML) — Single-Dose Vial (Intravenous)

500MG/50ML (10MG/ML) — Single-Dose Vial (Intravenous)

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

Approval Letters

35 letters from Drugs@FDA

Date	Submission	Document
Dec 21, 2021	SUPPL -5467	View Letter (PDF)
Dec 6, 2021	SUPPL -5465	View Letter (PDF)
Jul 1, 2021	SUPPL -5464	View Letter (PDF)
Sep 1, 2020	SUPPL -5460	View Letter (PDF)
Mar 17, 2020	SUPPL -5458	View Letter (PDF)
Jan 24, 2020	SUPPL -5461	View Letter (PDF)
Dec 3, 2019	SUPPL -5459	View Letter (PDF)
Oct 1, 2019	SUPPL -5457	View Letter (PDF)
Feb 13, 2019	SUPPL -5454	View Letter (PDF)
Oct 23, 2018	SUPPL -5451	View Letter (PDF)
Jun 14, 2018	SUPPL -5450	View Letter (PDF)
Apr 5, 2018	SUPPL -5453	View Letter (PDF)
Aug 14, 2014	SUPPL -5432	View Letter (PDF)
Sep 26, 2013	SUPPL -5414	View Letter (PDF)
May 13, 2013	SUPPL -5409	View Letter (PDF)
Oct 22, 2012	SUPPL -5367	View Letter (PDF)
Oct 22, 2012	SUPPL -5388	View Letter (PDF)
Jul 17, 2012	SUPPL -5373	View Letter (PDF)
Apr 19, 2012	SUPPL -5370	View Letter (PDF)
Feb 23, 2012	SUPPL -5362	View Letter (PDF)
Apr 22, 2011	SUPPL -5344	View Letter (PDF)
Feb 4, 2011	SUPPL -5332	View Letter (PDF)
Jan 14, 2011	SUPPL -5343	View Letter (PDF)
Feb 25, 2010	SUPPL -5311	View Letter (PDF)
Feb 25, 2010	SUPPL -5312	View Letter (PDF)
Oct 26, 2009	SUPPL -5299	View Letter (PDF)
Sep 16, 2008	SUPPL -5285	View Letter (PDF)
Sep 16, 2008	SUPPL -5291	View Letter (PDF)
Jan 30, 2008	SUPPL -5256	View Letter (PDF)
Oct 4, 2007	SUPPL -5262	View Letter (PDF)
Aug 30, 2007	SUPPL -5259	View Letter (PDF)
Mar 6, 2007	SUPPL -5247	View Letter (PDF)
Oct 5, 2006	SUPPL -5230	View Letter (PDF)
Mar 14, 2006	SUPPL -5211	View Letter (PDF)
Sep 22, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/10ML (10MG/ML)

▴

SOLUTION;INTRAVENOUS | Approved: 1997-11-26 00:00:00

No patent or exclusivity listings for this strength.

#002 — 500MG/50ML (10MG/ML)

▾

SOLUTION;INTRAVENOUS | Approved: 1997-11-26 00:00:00