Viewing data from:

NULOJIX

BLA

BELATACEPT | B125288 | BRISTOL MYERS SQUIBB

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

June 15, 2023(1114 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 15, 2023	Expired	Computed
7-Year Orphan	Jun. 15, 2018	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 9, 20457038 days remaining

Based on latest discovered patent 12441780(method of use) · relevance 90/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 78 patents →

Top 50 of 78 AI-discovered patents by relevance.

Composition

(33)

95/10012030923Grant: 2024-07-09 | Exp: 2044-07-04

92/10010808021Grant: 2020-10-20 | Exp: 2040-10-15

92/1007311910Grant: 2007-12-25 | Exp: 2027-12-20

88/10010590183Grant: 2020-03-17 | Exp: 2040-03-12

85/1007671022Grant: 2010-03-02 | Exp: 2030-02-25

85/1007605238Grant: 2009-10-20 | Exp: 2029-10-15

85/1007807786Grant: 2010-10-05 | Exp: 2030-09-30

82/1009926365Grant: 2018-03-27 | Exp: 2038-03-22

82/1007923539Grant: 2011-04-12 | Exp: 2031-04-07

80/1008969531Grant: 2015-03-03 | Exp: 2035-02-26

78/10012012452Grant: 2024-06-18 | Exp: 2044-06-13

75/1009469676Grant: 2016-10-18 | Exp: 2036-10-13

75/1008674076Grant: 2014-03-18 | Exp: 2034-03-13

75/10012419953Grant: 2025-09-23 | Exp: 2045-09-18

75/1007723479Grant: 2010-05-25 | Exp: 2030-05-20

75/10010400023Grant: 2019-09-03 | Exp: 2039-08-29

75/10011261233Grant: 2022-03-01 | Exp: 2042-02-24

75/10010538555Grant: 2020-01-21 | Exp: 2040-01-16

75/1009228018Grant: 2016-01-05 | Exp: 2035-12-31

75/1006830937Grant: 2004-12-14 | Exp: 2024-12-09

72/1008354513Grant: 2013-01-15 | Exp: 2033-01-10

72/1008664360Grant: 2014-03-04 | Exp: 2034-02-27

72/10011939367Grant: 2024-03-26 | Exp: 2044-03-21

70/10010961297Grant: 2021-03-30 | Exp: 2041-03-25

70/1009399052Grant: 2016-07-26 | Exp: 2036-07-21

70/1009850283Grant: 2017-12-26 | Exp: 2037-12-21

68/1008524232Grant: 2013-09-03 | Exp: 2033-08-29

65/1008815238Grant: 2014-08-26 | Exp: 2034-08-21

65/1009944678Grant: 2018-04-17 | Exp: 2038-04-12

65/1009695238Grant: 2017-07-04 | Exp: 2037-06-29

65/1007964711Grant: 2011-06-21 | Exp: 2031-06-16

65/1006984720Grant: 2006-01-10 | Exp: 2026-01-05

60/10011203630Grant: 2021-12-21 | Exp: 2041-12-16

Formulation

(1)

68/1007758860Grant: 2010-07-20 | Exp: 2030-07-15

Method of Use

(9)

92/10010488413Grant: 2019-11-26 | Exp: 2039-11-21

90/10011385228Grant: 2022-07-12 | Exp: 2042-07-07

90/10012441780Grant: 2025-10-14 | Exp: 2045-10-09

85/10010570204Grant: 2020-02-25 | Exp: 2040-02-20

85/1007070776Grant: 2006-07-04 | Exp: 2026-06-29

82/1007482327Grant: 2009-01-27 | Exp: 2029-01-22

78/10011708412Grant: 2023-07-25 | Exp: 2043-07-20

70/1006183734Grant: 2001-02-06 | Exp: 2021-02-01

70/1007105328Grant: 2006-09-12 | Exp: 2026-09-07

Manufacturing

(6)

88/1006800457Grant: 2004-10-05 | Exp: 2024-09-30

85/1009426970Grant: 2016-08-30 | Exp: 2036-08-25

72/10012234483Grant: 2025-02-25 | Exp: 2045-02-20

72/1008163551Grant: 2012-04-24 | Exp: 2032-04-19

65/1007122350Grant: 2006-10-17 | Exp: 2026-10-12

65/10010183967Grant: 2019-01-22 | Exp: 2039-01-17

Diagnostic

(1)

75/1007510844Grant: 2009-03-31 | Exp: 2029-03-26

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 125288

351(a) ReferenceLicensedCDERFor Injection

Proper Name

belatacept

Applicant

Bristol-Myers Squibb Company

Approval Date

15-Jun-11

Orphan Exclusivity

15-Jun-18

Expired

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jul 29, 2021	SUPPL -101	View Letter (PDF)
Apr 16, 2018	SUPPL -75	View Letter (PDF)
Nov 13, 2017	SUPPL -74	View Letter (PDF)
May 12, 2017	SUPPL -72	View Letter (PDF)
Feb 1, 2017	SUPPL -70	View Letter (PDF)
Oct 2, 2014	SUPPL -62	View Letter (PDF)
Apr 16, 2014	SUPPL -59	View Letter (PDF)
Apr 10, 2013	SUPPL -30	View Letter (PDF)
Jun 24, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG

▴

INJECTABLE; INJECTION | Approved: 2011-06-15 00:00:00

No patent or exclusivity listings for this strength.