Viewing data from:

POTELIGEO

BLA

MOGAMULIZUMAB-KPKC | B761051 | KYOWA KIRIN

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 8, 2030(1497 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 8, 2030	Active	Computed
7-Year Orphan	Aug. 8, 2025	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Apr. 25, 20446506 days remaining

Based on latest discovered patent 11970535(method of use) · relevance 50/100

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

Discovered Patents

View all 27 patents →

27 AI-discovered patents, sorted by relevance.

Composition

(11)

98/10010590203Grant: 2020-03-17 | Exp: 2040-03-12

95/1006989145Grant: 2006-01-24 | Exp: 2026-01-19

95/1008962806Grant: 2015-02-24 | Exp: 2035-02-19

92/1009441045Grant: 2016-09-13 | Exp: 2036-09-08

92/1009587028Grant: 2017-03-07 | Exp: 2037-03-02

92/1008039595Grant: 2011-10-18 | Exp: 2031-10-13

92/10010131711Grant: 2018-11-20 | Exp: 2038-11-15

90/10010584172Grant: 2020-03-10 | Exp: 2040-03-05

90/1009416169Grant: 2016-08-16 | Exp: 2036-08-11

88/1008197814Grant: 2012-06-12 | Exp: 2032-06-07

55/10010448622Grant: 2019-10-22 | Exp: 2039-10-17

Formulation

(1)

65/10010994011Grant: 2021-05-04 | Exp: 2041-04-29

Method of Use

(5)

92/1009642910Grant: 2017-05-09 | Exp: 2037-05-04

90/10010023649Grant: 2018-07-17 | Exp: 2038-07-12

89/10010294302Grant: 2019-05-21 | Exp: 2039-05-16

75/1009675625Grant: 2017-06-13 | Exp: 2037-06-08

50/10011970535Grant: 2024-04-30 | Exp: 2044-04-25

Manufacturing

(10)

60/1007064191Grant: 2006-06-20 | Exp: 2026-06-15

55/1009650411Grant: 2017-05-16 | Exp: 2037-05-11

55/1008835712Grant: 2014-09-16 | Exp: 2034-09-11

52/1009976163Grant: 2018-05-22 | Exp: 2038-05-17

50/1009725750Grant: 2017-08-08 | Exp: 2037-08-03

50/1009102971Grant: 2015-08-11 | Exp: 2035-08-06

50/10010076103Grant: 2018-09-18 | Exp: 2038-09-13

50/10011286459Grant: 2022-03-29 | Exp: 2042-03-24

50/1007816578Grant: 2010-10-19 | Exp: 2030-10-14

50/10010358671Grant: 2019-07-23 | Exp: 2039-07-18

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 761051

351(a) ReferenceLicensedCDERInjection

Proper Name

mogamulizumab-kpkc

Applicant

Kyowa Kirin, Inc.

Approval Date

8-Aug-18

Orphan Exclusivity

8-Aug-25

Expired

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Feb 23, 2026	SUPPL -25	View Letter (PDF)
Feb 4, 2025	SUPPL -18	View Letter (PDF)
Mar 31, 2022	SUPPL -15	View Letter (PDF)
Jul 12, 2021	SUPPL -11	View Letter (PDF)
Aug 8, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/5ML

▴

INJECTABLE;INJECTION | Approved: 2018-08-08 00:00:00

No patent or exclusivity listings for this strength.