Viewing data from:

ENTYVIO

BLA

VEDOLIZUMAB | B761133 | TAKEDA PHARMS USA

2 products0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 14, 20456858 days remaining

Based on latest discovered patent 12391760(method of use) · relevance 92/100

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

Discovered Patents

View all 19 patents →

19 AI-discovered patents, sorted by relevance.

Composition

(3)

65/1008673298Grant: 2014-03-18 | Exp: 2034-03-13

50/10011598024Grant: 2023-03-07 | Exp: 2043-03-02

50/1006183971Grant: 2001-02-06 | Exp: 2021-02-01

Formulation

(5)

90/10012286479Grant: 2025-04-29 | Exp: 2045-04-24

88/10012053526Grant: 2024-08-06 | Exp: 2044-08-01

60/1009694057Grant: 2017-07-04 | Exp: 2037-06-29

55/1009180189Grant: 2015-11-10 | Exp: 2035-11-05

50/10010238720Grant: 2019-03-26 | Exp: 2039-03-21

Method of Use

(8)

95/10011884731Grant: 2024-01-30 | Exp: 2044-01-25

92/10012171832Grant: 2024-12-24 | Exp: 2044-12-19

92/10012391760Grant: 2025-08-19 | Exp: 2045-08-14

92/10010324088Grant: 2019-06-18 | Exp: 2039-06-13

89/10011596688Grant: 2023-03-07 | Exp: 2043-03-02

88/10011760803Grant: 2023-09-19 | Exp: 2043-09-14

85/10012246064Grant: 2025-03-11 | Exp: 2045-03-06

85/10011389533Grant: 2022-07-19 | Exp: 2042-07-14

Manufacturing

(2)

55/10010138461Grant: 2018-11-27 | Exp: 2038-11-22

55/10010655099Grant: 2020-05-19 | Exp: 2040-05-14

Diagnostic

(1)

72/10011180565Grant: 2021-11-23 | Exp: 2041-11-18

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 761133 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

vedolizumab

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Approval Date

September 27, 2023

First Licensure

Not Eligible

Presentations

108MG/0.68ML — Pre-Filled Syringe (Subcutaneous)

108MG/0.68ML — Autoinjector (Subcutaneous)

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 27, 2026	SUPPL -14	View Letter (PDF)
Apr 19, 2024	SUPPL -5	View Letter (PDF)
Apr 19, 2024	SUPPL -6	View Letter (PDF)
Mar 15, 2024	SUPPL -4	View Letter (PDF)
Feb 26, 2024	SUPPL -3	View Letter (PDF)
Sep 28, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 300MG

▴

INJECTABLE;INTRAVENOUS | Approved: 2023-09-27 00:00:00

No patent or exclusivity listings for this strength.

#002 — 108MG/0.68ML

▾

INJECTABLE;INJECTION | Approved: 2023-09-27 00:00:00