Viewing data from:

ZINBRYTA

BLA

DACLIZUMAB | B761029 | BIOGEN

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

May 27, 2028(694 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 27, 2028	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 19, 20446744 days remaining

Based on latest discovered patent 12173080(manufacturing) · relevance 71/100

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

Discovered Patents

View all 209 patents →

Top 50 of 209 AI-discovered patents by relevance.

Composition

(17)

85/10010323098Grant: 2019-06-18 | Exp: 2039-06-13

85/1009266938Grant: 2016-02-23 | Exp: 2036-02-18

82/10011384131Grant: 2022-07-12 | Exp: 2042-07-07

75/1007465705Grant: 2008-12-16 | Exp: 2028-12-11

75/1006194551Grant: 2001-02-27 | Exp: 2021-02-22

75/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

75/10012023368Grant: 2024-07-02 | Exp: 2044-06-27

72/1008734774Grant: 2014-05-27 | Exp: 2034-05-22

72/1006323027Grant: 2001-11-27 | Exp: 2021-11-22

70/1008021661Grant: 2011-09-20 | Exp: 2031-09-15

70/10010683368Grant: 2020-06-16 | Exp: 2040-06-11

70/10011440971Grant: 2022-09-13 | Exp: 2042-09-08

70/10010618965Grant: 2020-04-14 | Exp: 2040-04-09

70/1008519112Grant: 2013-08-27 | Exp: 2033-08-22

65/1006528624Grant: 2003-03-04 | Exp: 2023-02-27

65/1007364731Grant: 2008-04-29 | Exp: 2028-04-24

65/1006685939Grant: 2004-02-03 | Exp: 2024-01-29

Formulation

(4)

90/1009017671Grant: 2015-04-28 | Exp: 2035-04-23

82/1008372396Grant: 2013-02-12 | Exp: 2033-02-07

65/1008318161Grant: 2012-11-27 | Exp: 2032-11-22

65/1009180189Grant: 2015-11-10 | Exp: 2035-11-05

Method of Use

(7)

95/1009809652Grant: 2017-11-07 | Exp: 2037-11-02

90/1008636997Grant: 2014-01-28 | Exp: 2034-01-23

87/1008298525Grant: 2012-10-30 | Exp: 2032-10-25

85/10012098178Grant: 2024-09-24 | Exp: 2044-09-19

82/1006406695Grant: 2002-06-18 | Exp: 2022-06-13

80/1007575742Grant: 2009-08-18 | Exp: 2029-08-13

65/1007678371Grant: 2010-03-16 | Exp: 2030-03-11

Manufacturing

(13)

75/10011697670Grant: 2023-07-11 | Exp: 2043-07-06

75/10010501491Grant: 2019-12-10 | Exp: 2039-12-05

75/10011802165Grant: 2023-10-31 | Exp: 2043-10-26

75/10011680110Grant: 2023-06-20 | Exp: 2043-06-15

75/1007575893Grant: 2009-08-18 | Exp: 2029-08-13

72/10010723762Grant: 2020-07-28 | Exp: 2040-07-23

71/10012173080Grant: 2024-12-24 | Exp: 2044-12-19

70/10011028149Grant: 2021-06-08 | Exp: 2041-06-03

68/10010590454Grant: 2020-03-17 | Exp: 2040-03-12

68/10011976127Grant: 2024-05-07 | Exp: 2044-05-02

65/1008642292Grant: 2014-02-04 | Exp: 2034-01-30

65/1009068212Grant: 2015-06-30 | Exp: 2035-06-25

65/10010889802Grant: 2021-01-12 | Exp: 2041-01-07

Diagnostic

(9)

95/10011686734Grant: 2023-06-27 | Exp: 2043-06-22

92/10010705095Grant: 2020-07-07 | Exp: 2040-07-02

90/1008871449Grant: 2014-10-28 | Exp: 2034-10-23

88/1008124350Grant: 2012-02-28 | Exp: 2032-02-23

85/10010955422Grant: 2021-03-23 | Exp: 2041-03-18

82/1009709575Grant: 2017-07-18 | Exp: 2037-07-13

75/1008227195Grant: 2012-07-24 | Exp: 2032-07-19

75/10010961585Grant: 2021-03-30 | Exp: 2041-03-25

72/10011913074Grant: 2024-02-27 | Exp: 2044-02-22

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 761029 | 2 presentations

351(a) ReferenceVoluntarily RevokedCDERInjection

Proper Name

daclizumab

Applicant

Biogen Inc.

Approval Date

27-May-16

Presentations

150MG/ML — Pre-Filled Syringe (Subcutaneous)

150MG/ML — Autoinjector (Subcutaneous)

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 7, 2017	SUPPL -5	View Letter (PDF)
Aug 31, 2017	SUPPL -7	View Letter (PDF)
Aug 31, 2017	SUPPL -2	View Letter (PDF)
May 31, 2017	SUPPL -1	View Letter (PDF)
May 31, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG/ML

▴

INJECTABLE;INJECTION | Approved: 2016-05-27 00:00:00

No patent or exclusivity listings for this strength.