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BLA

SACITUZUMAB GOVITECAN-HZIY | B761115 | IMMUNOMEDICS INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

April 22, 2032(2120 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Apr. 22, 2032	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 21, 20456989 days remaining

Based on latest discovered patent 12397063(composition) · 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 132 patents →

Top 50 of 132 AI-discovered patents by relevance.

Composition

(30)

95/10010669338Grant: 2020-06-02 | Exp: 2040-05-28

95/10010954305Grant: 2021-03-23 | Exp: 2041-03-18

95/10011052156Grant: 2021-07-06 | Exp: 2041-07-01

95/10012310958Grant: 2025-05-27 | Exp: 2045-05-22

92/10010034950Grant: 2018-07-31 | Exp: 2038-07-26

92/1009475884Grant: 2016-10-25 | Exp: 2036-10-20

92/1009931417Grant: 2018-04-03 | Exp: 2038-03-29

92/10010653793Grant: 2020-05-19 | Exp: 2040-05-14

92/10011116846Grant: 2021-09-14 | Exp: 2041-09-09

92/10010143756Grant: 2018-12-04 | Exp: 2038-11-29

92/10010682347Grant: 2020-06-16 | Exp: 2040-06-11

92/10012397063Grant: 2025-08-26 | Exp: 2045-08-21

90/1008268317Grant: 2012-09-18 | Exp: 2032-09-13

90/10010751420Grant: 2020-08-25 | Exp: 2040-08-20

90/10010849986Grant: 2020-12-01 | Exp: 2040-11-26

88/1009375489Grant: 2016-06-28 | Exp: 2036-06-23

88/10012257281Grant: 2025-03-25 | Exp: 2045-03-20

88/10011944689Grant: 2024-04-02 | Exp: 2044-03-28

85/1009107960Grant: 2015-08-18 | Exp: 2035-08-13

85/1009388237Grant: 2016-07-12 | Exp: 2036-07-07

85/1009833511Grant: 2017-12-05 | Exp: 2037-11-30

85/1008617558Grant: 2013-12-31 | Exp: 2033-12-26

85/1009745380Grant: 2017-08-29 | Exp: 2037-08-24

85/1007829531Grant: 2010-11-09 | Exp: 2030-11-04

85/1007585491Grant: 2009-09-08 | Exp: 2029-09-03

85/1009522194Grant: 2016-12-20 | Exp: 2036-12-15

85/1009629926Grant: 2017-04-25 | Exp: 2037-04-20

85/1009458242Grant: 2016-10-04 | Exp: 2036-09-29

85/10011066468Grant: 2021-07-20 | Exp: 2041-07-15

78/10012371507Grant: 2025-07-29 | Exp: 2045-07-24

Method of Use

(19)

98/10012364761Grant: 2025-07-22 | Exp: 2045-07-17

98/10010130718Grant: 2018-11-20 | Exp: 2038-11-15

95/10010266605Grant: 2019-04-23 | Exp: 2039-04-18

95/10010799597Grant: 2020-10-13 | Exp: 2040-10-08

95/10011052081Grant: 2021-07-06 | Exp: 2041-07-01

95/10010918721Grant: 2021-02-16 | Exp: 2041-02-11

95/10011439620Grant: 2022-09-13 | Exp: 2042-09-08

95/10011192955Grant: 2021-12-07 | Exp: 2041-12-02

95/10010413539Grant: 2019-09-17 | Exp: 2039-09-12

94/10010137196Grant: 2018-11-27 | Exp: 2038-11-22

92/10010130626Grant: 2018-11-20 | Exp: 2038-11-15

92/10010918734Grant: 2021-02-16 | Exp: 2041-02-11

92/10010744129Grant: 2020-08-18 | Exp: 2040-08-13

92/10010195175Grant: 2019-02-05 | Exp: 2039-01-31

92/10012251441Grant: 2025-03-18 | Exp: 2045-03-13

90/10011541047Grant: 2023-01-03 | Exp: 2042-12-29

86/1009481732Grant: 2016-11-01 | Exp: 2036-10-27

85/1009707302Grant: 2017-07-18 | Exp: 2037-07-13

82/1009226973Grant: 2016-01-05 | Exp: 2035-12-31

Manufacturing

(1)

85/10011712480Grant: 2023-08-01 | Exp: 2043-07-27

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 761115

351(a) ReferenceLicensedCDERFor Injection

Proper Name

sacituzumab govitecan-hziy

Applicant

Gilead Sciences, Inc.

Approval Date

22-Apr-20

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jun 26, 2026	SUPPL -64	View Letter (PDF)
Jun 26, 2026	SUPPL -63	View Letter (PDF)
Mar 28, 2025	SUPPL -59	View Letter (PDF)
Nov 26, 2024	SUPPL -58	View Letter (PDF)
Mar 20, 2023	SUPPL -36	View Letter (PDF)
Feb 6, 2023	SUPPL -35	View Letter (PDF)
Dec 6, 2022	SUPPL -31	View Letter (PDF)
Jun 6, 2022	SUPPL -23	View Letter (PDF)
Apr 14, 2021	SUPPL -9	View Letter (PDF)
Apr 9, 2021	SUPPL -13	View Letter (PDF)
Apr 9, 2021	SUPPL -5	View Letter (PDF)
Apr 23, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 180MG

▴

INJECTABLE;INJECTION | Approved: 2020-04-22 00:00:00

No patent or exclusivity listings for this strength.