Viewing data from:

PROLEUKIN

BLA

ALDESLEUKIN | B103293 | CHIRON

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

January 9, 2005(7845 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Jan. 9, 2005	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 28, 20456996 days remaining

Based on latest discovered patent 12403181(method of use) · relevance 72/100

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

Discovered Patents

View all 37 patents →

37 AI-discovered patents, sorted by relevance.

Composition

(16)

90/10012006354Grant: 2024-06-11 | Exp: 2044-06-06

88/10011122825Grant: 2021-09-21 | Exp: 2041-09-16

85/1006383487Grant: 2002-05-07 | Exp: 2022-05-02

85/10010654905Grant: 2020-05-19 | Exp: 2040-05-14

85/1006521230Grant: 2003-02-18 | Exp: 2023-02-13

85/10011384131Grant: 2022-07-12 | Exp: 2042-07-07

82/10010960079Grant: 2021-03-30 | Exp: 2041-03-25

82/10011091525Grant: 2021-08-17 | Exp: 2041-08-12

80/1009861705Grant: 2018-01-09 | Exp: 2038-01-04

75/10010889643Grant: 2021-01-12 | Exp: 2041-01-07

72/10011110150Grant: 2021-09-07 | Exp: 2041-09-02

72/10010265382Grant: 2019-04-23 | Exp: 2039-04-18

55/10011919946Grant: 2024-03-05 | Exp: 2044-02-29

50/10011028177Grant: 2021-06-08 | Exp: 2041-06-03

50/1009676841Grant: 2017-06-13 | Exp: 2037-06-08

50/1008747848Grant: 2014-06-10 | Exp: 2034-06-05

Formulation

(4)

88/10012247059Grant: 2025-03-11 | Exp: 2045-03-06

88/1009289381Grant: 2016-03-22 | Exp: 2036-03-17

52/1006306432Grant: 2001-10-23 | Exp: 2021-10-18

50/1007399463Grant: 2008-07-15 | Exp: 2028-07-10

Method of Use

(7)

96/1008012465Grant: 2011-09-06 | Exp: 2031-09-01

85/10011930837Grant: 2024-03-19 | Exp: 2044-03-14

85/1007048924Grant: 2006-05-23 | Exp: 2026-05-18

85/1006579521Grant: 2003-06-17 | Exp: 2023-06-12

72/10012403181Grant: 2025-09-02 | Exp: 2045-08-28

65/10012240884Grant: 2025-03-04 | Exp: 2045-02-27

55/1007015205Grant: 2006-03-21 | Exp: 2026-03-16

Manufacturing

(9)

72/10010273300Grant: 2019-04-30 | Exp: 2039-04-25

55/1008986957Grant: 2015-03-24 | Exp: 2035-03-19

55/10011512335Grant: 2022-11-29 | Exp: 2042-11-24

55/1009505803Grant: 2016-11-29 | Exp: 2036-11-24

50/10010030063Grant: 2018-07-24 | Exp: 2038-07-19

50/10011524070Grant: 2022-12-13 | Exp: 2042-12-08

50/1008765413Grant: 2014-07-01 | Exp: 2034-06-26

50/1009243224Grant: 2016-01-26 | Exp: 2036-01-21

50/10011851666Grant: 2023-12-26 | Exp: 2043-12-21

Diagnostic

(1)

50/10010705088Grant: 2020-07-07 | Exp: 2040-07-02

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 103293

351(a) ReferenceLicensedCDERFor Injection

Proper Name

aldesleukin

Applicant

Iovance Biotherapeutics Manufacturing LLC

Approval Date

5-May-92

Orphan Exclusivity

9-Jan-05

Expired

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 3, 2023	SUPPL -5154	View Letter (PDF)
May 20, 2019	SUPPL -5146	View Letter (PDF)
Aug 1, 2012	SUPPL -5130	View Letter (PDF)
Jan 5, 2012	SUPPL -5123	View Letter (PDF)
Aug 2, 2011	SUPPL -5114	View Letter (PDF)
Mar 26, 2004	SUPPL -1021	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 22MIU/VIAL

▴

VIAL | Approved: 1992-05-05 00:00:00

No patent or exclusivity listings for this strength.