Viewing data from:

ZINPLAVA

BLA

BEZLOTOXUMAB | B761046 | MERCK SHARP DOHME

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

October 21, 2028(841 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Oct. 21, 2028	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 7, 20456975 days remaining

Based on latest discovered patent 12385913(diagnostic) · relevance 55/100

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

Discovered Patents

View all 60 patents →

Top 50 of 60 AI-discovered patents by relevance.

Composition

(23)

94/1009181632Grant: 2015-11-10 | Exp: 2035-11-05

72/10011666611Grant: 2023-06-06 | Exp: 2043-06-01

72/10011919954Grant: 2024-03-05 | Exp: 2044-02-29

70/10011312777Grant: 2022-04-26 | Exp: 2042-04-21

70/10011866505Grant: 2024-01-09 | Exp: 2044-01-04

70/1008163286Grant: 2012-04-24 | Exp: 2032-04-19

65/1008232449Grant: 2012-07-31 | Exp: 2032-07-26

65/10012042524Grant: 2024-07-23 | Exp: 2044-07-18

65/1008361470Grant: 2013-01-29 | Exp: 2033-01-24

65/1009878038Grant: 2018-01-30 | Exp: 2038-01-25

62/1008557544Grant: 2013-10-15 | Exp: 2033-10-10

60/10012030923Grant: 2024-07-09 | Exp: 2044-07-04

55/10011020490Grant: 2021-06-01 | Exp: 2041-05-27

55/10010077306Grant: 2018-09-18 | Exp: 2038-09-13

55/1008481683Grant: 2013-07-09 | Exp: 2033-07-04

55/1008557232Grant: 2013-10-15 | Exp: 2033-10-10

55/1008124088Grant: 2012-02-28 | Exp: 2032-02-23

55/1007422743Grant: 2008-09-09 | Exp: 2028-09-04

55/10011952420Grant: 2024-04-09 | Exp: 2044-04-04

52/1008815238Grant: 2014-08-26 | Exp: 2034-08-21

50/1006759509Grant: 2004-07-06 | Exp: 2024-07-01

50/10011952421Grant: 2024-04-09 | Exp: 2044-04-04

50/1007858759Grant: 2010-12-28 | Exp: 2030-12-23

Method of Use

(4)

65/1007422742Grant: 2008-09-09 | Exp: 2028-09-04

55/1008377438Grant: 2013-02-19 | Exp: 2033-02-14

50/1008974783Grant: 2015-03-10 | Exp: 2035-03-05

50/1007939295Grant: 2011-05-10 | Exp: 2031-05-05

Manufacturing

(12)

65/1006410270Grant: 2002-06-25 | Exp: 2022-06-20

55/10012234483Grant: 2025-02-25 | Exp: 2045-02-20

55/10012103949Grant: 2024-10-01 | Exp: 2044-09-26

55/1008158419Grant: 2012-04-17 | Exp: 2032-04-12

55/10010065987Grant: 2018-09-04 | Exp: 2038-08-30

55/10010590457Grant: 2020-03-17 | Exp: 2040-03-12

55/10012325875Grant: 2025-06-10 | Exp: 2045-06-05

55/1008835712Grant: 2014-09-16 | Exp: 2034-09-11

50/1009693539Grant: 2017-07-04 | Exp: 2037-06-29

50/1008129508Grant: 2012-03-06 | Exp: 2032-03-01

50/10010030225Grant: 2018-07-24 | Exp: 2038-07-19

50/10012157073Grant: 2024-12-03 | Exp: 2044-11-28

Diagnostic

(1)

55/10012385913Grant: 2025-08-12 | Exp: 2045-08-07

other

(10)

92/10012071666Grant: 2024-08-27 | Exp: 2044-08-22

75/1009388394Grant: 2016-07-12 | Exp: 2036-07-07

70/10011104721Grant: 2021-08-31 | Exp: 2041-08-26

65/10012350340Grant: 2025-07-08 | Exp: 2045-07-03

65/10011207412Grant: 2021-12-28 | Exp: 2041-12-23

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

52/10012358944Grant: 2025-07-15 | Exp: 2045-07-10

50/10011130818Grant: 2021-09-28 | Exp: 2041-09-23

50/1009624299Grant: 2017-04-18 | Exp: 2037-04-13

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

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 761046

351(a) ReferenceLicensedCDERInjection

Proper Name

bezlotoxumab

Applicant

Merck Sharp & Dohme LLC

Approval Date

21-Oct-16

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 30, 2023	SUPPL -12	View Letter (PDF)
Oct 25, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1000ML/40ML

▴

INJECTABLE;INJECTION | Approved: 2016-10-21 00:00:00

No patent or exclusivity listings for this strength.