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nogapendekin alfa inbakicept-pmln | B761336 | ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

April 22, 2036(3581 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Apr. 22, 2036	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 8, 20456884 days remaining

Based on latest discovered patent 12297229(manufacturing) · relevance 82/100

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

Discovered Patents

View all 67 patents →

Top 50 of 67 AI-discovered patents by relevance.

Composition

(9)

75/10010450359Grant: 2019-10-22 | Exp: 2039-10-17

75/1009464127Grant: 2016-10-11 | Exp: 2036-10-06

72/1008163879Grant: 2012-04-24 | Exp: 2032-04-19

70/1007884198Grant: 2011-02-08 | Exp: 2031-02-03

60/1008492118Grant: 2013-07-23 | Exp: 2033-07-18

60/1008420087Grant: 2013-04-16 | Exp: 2033-04-11

60/1008105830Grant: 2012-01-31 | Exp: 2032-01-26

60/1007511122Grant: 2009-03-31 | Exp: 2029-03-26

55/1007456263Grant: 2008-11-25 | Exp: 2028-11-20

Manufacturing

(40)

82/10012297229Grant: 2025-05-13 | Exp: 2045-05-08

75/10011975293Grant: 2024-05-07 | Exp: 2044-05-02

75/10011679340Grant: 2023-06-20 | Exp: 2043-06-15

72/1008557113Grant: 2013-10-15 | Exp: 2033-10-10

70/10010865224Grant: 2020-12-15 | Exp: 2040-12-10

70/1008999702Grant: 2015-04-07 | Exp: 2035-04-02

70/1009951101Grant: 2018-04-24 | Exp: 2038-04-19

68/10011634457Grant: 2023-04-25 | Exp: 2043-04-20

68/1008916045Grant: 2014-12-23 | Exp: 2034-12-18

65/1008506798Grant: 2013-08-13 | Exp: 2033-08-08

65/1008652330Grant: 2014-02-18 | Exp: 2034-02-13

65/1009587009Grant: 2017-03-07 | Exp: 2037-03-02

65/1009376474Grant: 2016-06-28 | Exp: 2036-06-23

65/10011236125Grant: 2022-02-01 | Exp: 2042-01-27

65/10011472836Grant: 2022-10-18 | Exp: 2042-10-13

65/10010287314Grant: 2019-05-14 | Exp: 2039-05-09

65/1008754196Grant: 2014-06-17 | Exp: 2034-06-12

65/1008163886Grant: 2012-04-24 | Exp: 2032-04-19

65/10012076666Grant: 2024-09-03 | Exp: 2044-08-29

65/1008536316Grant: 2013-09-17 | Exp: 2033-09-12

60/1009096648Grant: 2015-08-04 | Exp: 2035-07-30

60/10010472389Grant: 2019-11-12 | Exp: 2039-11-07

60/10010233211Grant: 2019-03-19 | Exp: 2039-03-14

60/1008900454Grant: 2014-12-02 | Exp: 2034-11-27

60/1009067976Grant: 2015-06-30 | Exp: 2035-06-25

60/1009029517Grant: 2015-05-12 | Exp: 2035-05-07

60/1008733556Grant: 2014-05-27 | Exp: 2034-05-22

60/1009057079Grant: 2015-06-16 | Exp: 2035-06-11

60/1009234010Grant: 2016-01-12 | Exp: 2036-01-07

58/10010550148Grant: 2020-02-04 | Exp: 2040-01-30

58/1008343356Grant: 2013-01-01 | Exp: 2032-12-27

55/10010793593Grant: 2020-10-06 | Exp: 2040-10-01

55/1009803165Grant: 2017-10-31 | Exp: 2037-10-26

55/10011617988Grant: 2023-04-04 | Exp: 2043-03-30

55/1009731288Grant: 2017-08-15 | Exp: 2037-08-10

55/10012281297Grant: 2025-04-22 | Exp: 2045-04-17

55/10011110373Grant: 2021-09-07 | Exp: 2041-09-02

55/1008338577Grant: 2012-12-25 | Exp: 2032-12-20

55/1009809799Grant: 2017-11-07 | Exp: 2037-11-02

55/10010072050Grant: 2018-09-11 | Exp: 2038-09-06

Device

(1)

60/1009174145Grant: 2015-11-03 | Exp: 2035-10-29

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 761336

351(a) ReferenceLicensedCDERSolution

Proper Name

nogapendekin alfa inbakicept-pmln

Applicant

Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.

Approval Date

22-Apr-24

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 23, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 400mcg/0.4 mL

▴

SOLUTION;INTRAVESICAL | Approved: 2024-04-22 00:00:00

No patent or exclusivity listings for this strength.