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BLA

DATOPOTAMAB DERUXTECAN-DLNK | B761394 | DAIICHI SANKYO INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

January 17, 2037(3851 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jan. 17, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jan. 23, 20456779 days remaining

Based on latest discovered patent 12209099(composition) · relevance 75/100

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

Discovered Patents

View all 156 patents →

Top 50 of 156 AI-discovered patents by relevance.

Composition

(35)

95/1009919056Grant: 2018-03-20 | Exp: 2038-03-15

95/10010662239Grant: 2020-05-26 | Exp: 2040-05-21

92/10010722594Grant: 2020-07-28 | Exp: 2040-07-23

90/1009956299Grant: 2018-05-01 | Exp: 2038-04-26

90/10011690918Grant: 2023-07-04 | Exp: 2043-06-29

88/1009579366Grant: 2017-02-28 | Exp: 2037-02-23

85/1006982323Grant: 2006-01-03 | Exp: 2025-12-29

85/10010744204Grant: 2020-08-18 | Exp: 2040-08-13

85/1008940874Grant: 2015-01-27 | Exp: 2035-01-22

85/1009266939Grant: 2016-02-23 | Exp: 2036-02-18

85/10011286297Grant: 2022-03-29 | Exp: 2042-03-24

85/1008697396Grant: 2014-04-15 | Exp: 2034-04-10

85/10011053307Grant: 2021-07-06 | Exp: 2041-07-01

85/10010799596Grant: 2020-10-13 | Exp: 2040-10-08

85/1007354584Grant: 2008-04-08 | Exp: 2028-04-03

82/1009315571Grant: 2016-04-19 | Exp: 2036-04-14

82/1009745303Grant: 2017-08-29 | Exp: 2037-08-24

75/10010994023Grant: 2021-05-04 | Exp: 2041-04-29

75/1008119130Grant: 2012-02-21 | Exp: 2032-02-16

75/1009676854Grant: 2017-06-13 | Exp: 2037-06-08

75/1009527927Grant: 2016-12-27 | Exp: 2036-12-22

75/10011198725Grant: 2021-12-14 | Exp: 2041-12-09

75/10011912782Grant: 2024-02-27 | Exp: 2044-02-22

75/1009206255Grant: 2015-12-08 | Exp: 2035-12-03

75/10012209099Grant: 2025-01-28 | Exp: 2045-01-23

75/10010188746Grant: 2019-01-29 | Exp: 2039-01-24

75/10011779650Grant: 2023-10-10 | Exp: 2043-10-05

75/10010420777Grant: 2019-09-24 | Exp: 2039-09-19

75/1009593154Grant: 2017-03-14 | Exp: 2037-03-09

75/10010557161Grant: 2020-02-11 | Exp: 2040-02-06

75/1007399594Grant: 2008-07-15 | Exp: 2028-07-10

75/10012178876Grant: 2024-12-31 | Exp: 2044-12-26

75/10010160800Grant: 2018-12-25 | Exp: 2038-12-20

75/1009011852Grant: 2015-04-21 | Exp: 2035-04-16

75/10010117889Grant: 2018-11-06 | Exp: 2038-11-01

Method of Use

(3)

85/10011400140Grant: 2022-08-02 | Exp: 2042-07-28

85/10011938192Grant: 2024-03-26 | Exp: 2044-03-21

78/1006846801Grant: 2005-01-25 | Exp: 2025-01-20

Manufacturing

(12)

92/10010072083Grant: 2018-09-11 | Exp: 2038-09-06

92/10011136396Grant: 2021-10-05 | Exp: 2041-09-30

85/1006962777Grant: 2005-11-08 | Exp: 2025-11-03

85/1007723270Grant: 2010-05-25 | Exp: 2030-05-20

80/10010683340Grant: 2020-06-16 | Exp: 2040-06-11

75/10010556955Grant: 2020-02-11 | Exp: 2040-02-06

75/1006261765Grant: 2001-07-17 | Exp: 2021-07-12

75/1006916605Grant: 2005-07-12 | Exp: 2025-07-07

75/10010259842Grant: 2019-04-16 | Exp: 2039-04-11

75/10011845966Grant: 2023-12-19 | Exp: 2043-12-14

75/1007414111Grant: 2008-08-19 | Exp: 2028-08-14

75/1009068198Grant: 2015-06-30 | Exp: 2035-06-25

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 761394

351(a) ReferenceLicensedCDERInjection

Proper Name

datopotamab deruxtecan-dlnk

Applicant

Daiichi Sankyo, Inc

Approval Date

17-Jan-25

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 27, 2026	SUPPL -3	View Letter (PDF)
Feb 4, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

▴

INJECTABLE; IV (INFUSION) | Approved: 2025-01-17 00:00:00

No patent or exclusivity listings for this strength.