Viewing data from:

ILUMYA

BLA

TILDRAKIZUMAB-ASMN | B761067 | SUN PHARMA GLOBAL

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

March 20, 2030(1356 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 20, 2030	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 18, 20457017 days remaining

Based on latest discovered patent 12421524(manufacturing) · 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 33 patents →

33 AI-discovered patents, sorted by relevance.

Composition

(12)

95/1008293883Grant: 2012-10-23 | Exp: 2032-10-18

92/1008513389Grant: 2013-08-20 | Exp: 2033-08-15

92/1008362212Grant: 2013-01-29 | Exp: 2033-01-24

92/1008404813Grant: 2013-03-26 | Exp: 2033-03-21

88/1009809648Grant: 2017-11-07 | Exp: 2037-11-02

85/10011014986Grant: 2021-05-25 | Exp: 2041-05-20

70/10011332544Grant: 2022-05-17 | Exp: 2042-05-12

68/10010640559Grant: 2020-05-05 | Exp: 2040-04-30

65/10011999789Grant: 2024-06-04 | Exp: 2044-05-30

55/10011959118Grant: 2024-04-16 | Exp: 2044-04-11

52/1007670595Grant: 2010-03-02 | Exp: 2030-02-25

50/1008372402Grant: 2013-02-12 | Exp: 2033-02-07

Formulation

(2)

55/10011207412Grant: 2021-12-28 | Exp: 2041-12-23

55/10012350340Grant: 2025-07-08 | Exp: 2045-07-03

Method of Use

(6)

92/1008795666Grant: 2014-08-05 | Exp: 2034-07-31

90/10011168134Grant: 2021-11-09 | Exp: 2041-11-04

85/10011352421Grant: 2022-06-07 | Exp: 2042-06-02

85/1007740848Grant: 2010-06-22 | Exp: 2030-06-17

70/1008178095Grant: 2012-05-15 | Exp: 2032-05-10

55/1007422742Grant: 2008-09-09 | Exp: 2028-09-04

Manufacturing

(12)

55/10010793592Grant: 2020-10-06 | Exp: 2040-10-01

55/10011220668Grant: 2022-01-11 | Exp: 2042-01-06

55/1009975920Grant: 2018-05-22 | Exp: 2038-05-17

55/10010519194Grant: 2019-12-31 | Exp: 2039-12-26

50/10012421524Grant: 2025-09-23 | Exp: 2045-09-18

50/10011554361Grant: 2023-01-17 | Exp: 2043-01-12

50/10010138477Grant: 2018-11-27 | Exp: 2038-11-22

50/1008470593Grant: 2013-06-25 | Exp: 2033-06-20

50/1008137933Grant: 2012-03-20 | Exp: 2032-03-15

50/10012162938Grant: 2024-12-10 | Exp: 2044-12-05

50/1009428784Grant: 2016-08-30 | Exp: 2036-08-25

50/1009175284Grant: 2015-11-03 | Exp: 2035-10-29

Diagnostic

(1)

75/1007427402Grant: 2008-09-23 | Exp: 2028-09-18

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 761067

351(a) ReferenceLicensedCDERInjection

Proper Name

tildrakizumab-asmn

Applicant

Sun Pharmaceutical Industries Limited

Approval Date

20-Mar-18

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Dec 15, 2025	SUPPL -24	View Letter (PDF)
Apr 4, 2024	SUPPL -18	View Letter (PDF)
Dec 21, 2022	SUPPL -14	View Letter (PDF)
Mar 22, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/1ML

▴

INJECTABLE;INJECTION | Approved: 2018-03-20 00:00:00

No patent or exclusivity listings for this strength.