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BLA

TELISOTUZUMAB VEDOTIN-TLLV | B761384 | ABBVIE INC

2 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

May 14, 2037(3968 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 14, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 2, 20457031 days remaining

Based on latest discovered patent 12433951(method of use) · relevance 95/100

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

Discovered Patents

View all 136 patents →

Top 50 of 136 AI-discovered patents by relevance.

Composition

(27)

95/1009803009Grant: 2017-10-31 | Exp: 2037-10-26

88/1008206723Grant: 2012-06-26 | Exp: 2032-06-21

85/1007501120Grant: 2009-03-10 | Exp: 2029-03-05

85/1009951125Grant: 2018-04-24 | Exp: 2038-04-19

85/1009381256Grant: 2016-07-05 | Exp: 2036-06-30

85/1008426402Grant: 2013-04-23 | Exp: 2033-04-18

85/1009777071Grant: 2017-10-03 | Exp: 2037-09-28

85/1009796776Grant: 2017-10-24 | Exp: 2037-10-19

82/10011135308Grant: 2021-10-05 | Exp: 2041-09-30

82/10012365729Grant: 2025-07-22 | Exp: 2045-07-17

82/1007514080Grant: 2009-04-07 | Exp: 2029-04-02

78/1009867887Grant: 2018-01-16 | Exp: 2038-01-11

75/1008012485Grant: 2011-09-06 | Exp: 2031-09-01

75/10011033634Grant: 2021-06-15 | Exp: 2041-06-10

75/1009764042Grant: 2017-09-19 | Exp: 2037-09-14

75/10012157776Grant: 2024-12-03 | Exp: 2044-11-28

75/1009856319Grant: 2018-01-02 | Exp: 2037-12-28

75/1009447181Grant: 2016-09-20 | Exp: 2036-09-15

75/1009770518Grant: 2017-09-26 | Exp: 2037-09-21

75/1009944720Grant: 2018-04-17 | Exp: 2038-04-12

75/1009872922Grant: 2018-01-23 | Exp: 2038-01-18

72/1009434748Grant: 2016-09-06 | Exp: 2036-09-01

72/1009901647Grant: 2018-02-27 | Exp: 2038-02-22

72/10011116845Grant: 2021-09-14 | Exp: 2041-09-09

72/10010752683Grant: 2020-08-25 | Exp: 2040-08-20

72/1009624240Grant: 2017-04-18 | Exp: 2037-04-13

72/10011505617Grant: 2022-11-22 | Exp: 2042-11-17

Formulation

(4)

82/10010603388Grant: 2020-03-31 | Exp: 2040-03-26

75/1009943576Grant: 2018-04-17 | Exp: 2038-04-12

72/1008946170Grant: 2015-02-03 | Exp: 2035-01-29

72/1009579385Grant: 2017-02-28 | Exp: 2037-02-23

Method of Use

(8)

95/10012433951Grant: 2025-10-07 | Exp: 2045-10-02

85/1007211262Grant: 2007-05-01 | Exp: 2027-04-26

85/1009550986Grant: 2017-01-24 | Exp: 2037-01-19

75/1007140371Grant: 2006-11-28 | Exp: 2026-11-23

75/1008071550Grant: 2011-12-06 | Exp: 2031-12-01

75/1007291344Grant: 2007-11-06 | Exp: 2027-11-01

72/1007964191Grant: 2011-06-21 | Exp: 2031-06-16

72/1009321745Grant: 2016-04-26 | Exp: 2036-04-21

Manufacturing

(9)

78/10010370389Grant: 2019-08-06 | Exp: 2039-08-01

75/1008491904Grant: 2013-07-23 | Exp: 2033-07-18

75/1009873708Grant: 2018-01-23 | Exp: 2038-01-18

75/1008633139Grant: 2014-01-21 | Exp: 2034-01-16

75/10010385071Grant: 2019-08-20 | Exp: 2039-08-15

72/1009266950Grant: 2016-02-23 | Exp: 2036-02-18

72/10010287256Grant: 2019-05-14 | Exp: 2039-05-09

72/10012157767Grant: 2024-12-03 | Exp: 2044-11-28

72/10010035817Grant: 2018-07-31 | Exp: 2038-07-26

Device

(1)

75/10010780218Grant: 2020-09-22 | Exp: 2040-09-17

Diagnostic

(1)

72/1009170262Grant: 2015-10-27 | Exp: 2035-10-22

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 761384 | 2 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

telisotuzumab vedotin-tllv

Applicant

AbbVie Inc.

Approval Date

14-May-25

Presentations

20MG — Single-Dose Vial (Intravenous)

100MG — Single-Dose Vial (Intravenous)

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 23, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG

▴

VIAL;SINGLE-DOSE | Approved: 2025-05-14 00:00:00

No patent or exclusivity listings for this strength.

#002 — 100MG

▾

VIAL;SINGLE-DOSE | Approved: 2025-05-14 00:00:00