Viewing data from:

TYSABRI

BLA

NATALIZUMAB | B125104 | BIOGEN IDEC

1 product32 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 1, 2036(3621 days remaining)

Purple Book Patents (32)

Patent	Expiration	Status
10119976	May. 27, 2034	Active
11292845	Feb. 28, 2027	Active
10233245	Feb. 28, 2027	Active
9493567	Mar. 5, 2027	Active
9994968	Aug. 19, 2034	Active
10676772	Aug. 19, 2034	Active
11268119	Feb. 21, 2036	Active
11124760	Aug. 27, 2035	Active
9096879	Jan. 7, 2031	Active
7759117	Jun. 21, 2024	Expired
7157276	Jun. 21, 2024	Expired
9109015	Aug. 13, 2031	Active
9212379	Nov. 28, 2030	Active
8318416	Jan. 20, 2031	Active
10308706	Feb. 5, 2031	Active
9005926	Oct. 1, 2030	Active
10590454	May. 11, 2032	Active
9562252	May. 11, 2033	Active
10023831	Mar. 17, 2035	Active
10844416	Jun. 1, 2036	Active
9709575	Apr. 4, 2026	Expired
8809049	May. 22, 2031	Active
9696307	Feb. 5, 2030	Active
10705095	Apr. 4, 2026	Expired
8871449	Apr. 12, 2026	Expired
8124350	Aug. 2, 2027	Active
11287423	Jan. 11, 2031	Active
10444234	Jan. 11, 2031	Active
9316641	Jan. 9, 2032	Active
11280794	May. 27, 2034	Active
10677803	May. 27, 2034	Active
9790533	May. 11, 2032	Active

Discovered Patents

View all 90 patents →

Top 50 of 90 AI-discovered patents by relevance.

Composition

(7)

88/1007776891Grant: 2010-08-17 | Exp: 2030-08-12

88/1007514409Grant: 2009-04-07 | Exp: 2029-04-02

85/1007655417Grant: 2010-02-02 | Exp: 2030-01-28

85/10011939369Grant: 2024-03-26 | Exp: 2044-03-21

75/1009902774Grant: 2018-02-27 | Exp: 2038-02-22

75/1007196112Grant: 2007-03-27 | Exp: 2027-03-22

75/1006307025Grant: 2001-10-23 | Exp: 2021-10-18

Formulation

(4)

92/1008900577Grant: 2014-12-02 | Exp: 2034-11-27

92/1009533044Grant: 2017-01-03 | Exp: 2036-12-29

90/1008815236Grant: 2014-08-26 | Exp: 2034-08-21

88/10010954303Grant: 2021-03-23 | Exp: 2041-03-18

Method of Use

(15)

96/10011248051Grant: 2022-02-15 | Exp: 2042-02-10

95/10011280794Grant: 2022-03-22 | Exp: 2042-03-17

95/10010233245Grant: 2019-03-19 | Exp: 2039-03-14

95/1009493567Grant: 2016-11-15 | Exp: 2036-11-10

93/10011333670Grant: 2022-05-17 | Exp: 2042-05-12

90/10010240205Grant: 2019-03-26 | Exp: 2039-03-21

90/1007807167Grant: 2010-10-05 | Exp: 2030-09-30

90/1007176184Grant: 2007-02-13 | Exp: 2027-02-08

89/10012105090Grant: 2024-10-01 | Exp: 2044-09-26

88/1009441041Grant: 2016-09-13 | Exp: 2036-09-08

88/1009193790Grant: 2015-11-24 | Exp: 2035-11-19

88/10010466251Grant: 2019-11-05 | Exp: 2039-10-31

85/10010677803Grant: 2020-06-09 | Exp: 2040-06-04

85/10011292845Grant: 2022-04-05 | Exp: 2042-03-31

80/1009896509Grant: 2018-02-20 | Exp: 2038-02-15

Manufacturing

(3)

85/10011753668Grant: 2023-09-12 | Exp: 2043-09-07

85/10010844416Grant: 2020-11-24 | Exp: 2040-11-19

75/10011697670Grant: 2023-07-11 | Exp: 2043-07-06

Diagnostic

(21)

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

92/10012392784Grant: 2025-08-19 | Exp: 2045-08-14

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

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

90/10012031990Grant: 2024-07-09 | Exp: 2044-07-04

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

88/10011079393Grant: 2021-08-03 | Exp: 2041-07-29

85/10011280793Grant: 2022-03-22 | Exp: 2042-03-17

85/10010955422Grant: 2021-03-23 | Exp: 2041-03-18

85/10012066442Grant: 2024-08-20 | Exp: 2044-08-15

85/10010302654Grant: 2019-05-28 | Exp: 2039-05-23

85/1009726672Grant: 2017-08-08 | Exp: 2037-08-03

85/10010119976Grant: 2018-11-06 | Exp: 2038-11-01

82/1009709575Grant: 2017-07-18 | Exp: 2037-07-13

80/10012345703Grant: 2025-07-01 | Exp: 2045-06-26

78/10012385925Grant: 2025-08-12 | Exp: 2045-08-07

78/1009377458Grant: 2016-06-28 | Exp: 2036-06-23

75/1009717453Grant: 2017-08-01 | Exp: 2037-07-27

75/10010563264Grant: 2020-02-18 | Exp: 2040-02-13

75/10010961585Grant: 2021-03-30 | Exp: 2041-03-25

75/10012054778Grant: 2024-08-06 | Exp: 2044-08-01

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
PGR2022-00054	11292845	PGR	Sandoz Inc.	Institution Denied	2022-07-29	2023-02-02

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 125104 | 32 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

natalizumab

Applicant

Biogen Inc.

Approval Date

23-Nov-04

Listed Patents

Patent Number	Expiration
10119976	May 27, 2034
11292845	February 28, 2027
10233245	February 28, 2027
9493567	March 5, 2027
9994968	August 19, 2034
10676772	August 19, 2034
11268119	February 21, 2036
11124760	August 27, 2035
9096879	January 7, 2031
7759117	June 21, 2024
7157276	June 21, 2024
9109015	August 13, 2031
9212379	November 28, 2030
8318416	January 20, 2031
10308706	February 5, 2031
9005926	October 1, 2030
10590454	May 11, 2032
9562252	May 11, 2033
10023831	March 17, 2035
10844416	June 1, 2036
9709575	April 4, 2026
8809049	May 22, 2031
9696307	February 5, 2030
10705095	April 4, 2026
8871449	April 12, 2026
8124350	August 2, 2027
11287423	January 11, 2031
10444234	January 11, 2031
9316641	January 9, 2032
11280794	May 27, 2034
10677803	May 27, 2034
9790533	May 11, 2032

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

Approval Letters

29 letters from Drugs@FDA

Date	Submission	Document
Mar 19, 2025	SUPPL -984	View Letter (PDF)
Oct 27, 2023	SUPPL -980	View Letter (PDF)
Aug 28, 2023	SUPPL -977	View Letter (PDF)
Apr 12, 2023	SUPPL -979	View Letter (PDF)
Apr 12, 2023	SUPPL -976	View Letter (PDF)
Dec 14, 2021	SUPPL -975	View Letter (PDF)
Dec 14, 2021	SUPPL -973	View Letter (PDF)
Oct 9, 2020	SUPPL -971	View Letter (PDF)
Jun 19, 2020	SUPPL -968	View Letter (PDF)
Jun 18, 2020	SUPPL -969	View Letter (PDF)
Aug 7, 2019	SUPPL -966	View Letter (PDF)
Apr 23, 2018	SUPPL -960	View Letter (PDF)
Apr 23, 2018	SUPPL -963	View Letter (PDF)
Aug 21, 2017	SUPPL -959	View Letter (PDF)
Oct 12, 2016	SUPPL -958	View Letter (PDF)
May 20, 2016	SUPPL -955	View Letter (PDF)
May 20, 2016	SUPPL -953	View Letter (PDF)
May 13, 2015	SUPPL -950	View Letter (PDF)
Dec 17, 2013	SUPPL -889	View Letter (PDF)
Dec 17, 2013	SUPPL -840	View Letter (PDF)
Dec 17, 2013	SUPPL -847	View Letter (PDF)
May 28, 2013	SUPPL -813	View Letter (PDF)
Jan 31, 2012	SUPPL -570	View Letter (PDF)
Jan 31, 2012	SUPPL -576	View Letter (PDF)
Nov 3, 2008	SUPPL -67	View Letter (PDF)
Nov 3, 2008	SUPPL -106	View Letter (PDF)
Jan 23, 2008	SUPPL -33	View Letter (PDF)
Jun 6, 2006	SUPPL -15	View Letter (PDF)
Nov 24, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

▴

VIAL; SINGLE-USE | Approved: 2004-11-23 00:00:00

No patent or exclusivity listings for this strength.