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SAPHNELO

BLA

ANIFROLUMAB-FNIA | B761123 | ASTRAZENECA AB

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

July 30, 2033(2584 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jul. 30, 2033	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 26, 20446751 days remaining

Based on latest discovered patent 12178876(composition) · relevance 50/100

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

Discovered Patents

View all 21 patents →

21 AI-discovered patents, sorted by relevance.

Composition

(13)

95/10010301390Grant: 2019-05-28 | Exp: 2039-05-23

93/1009988459Grant: 2018-06-05 | Exp: 2038-05-31

70/10010011660Grant: 2018-07-03 | Exp: 2038-06-28

65/1008697396Grant: 2014-04-15 | Exp: 2034-04-10

55/1007393648Grant: 2008-07-01 | Exp: 2028-06-26

50/1009526798Grant: 2016-12-27 | Exp: 2036-12-22

50/10012178876Grant: 2024-12-31 | Exp: 2044-12-26

50/10011795225Grant: 2023-10-24 | Exp: 2043-10-19

50/1007482434Grant: 2009-01-27 | Exp: 2029-01-22

50/10010428131Grant: 2019-10-01 | Exp: 2039-09-26

50/10011701430Grant: 2023-07-18 | Exp: 2043-07-13

50/1008008443Grant: 2011-08-30 | Exp: 2031-08-25

50/10010576164Grant: 2020-03-03 | Exp: 2040-02-27

Manufacturing

(7)

60/10010259842Grant: 2019-04-16 | Exp: 2039-04-11

55/1008309690Grant: 2012-11-13 | Exp: 2032-11-08

50/10011414477Grant: 2022-08-16 | Exp: 2042-08-11

50/1007723270Grant: 2010-05-25 | Exp: 2030-05-20

50/1006492160Grant: 2002-12-10 | Exp: 2022-12-05

50/1007662557Grant: 2010-02-16 | Exp: 2030-02-11

50/1008822214Grant: 2014-09-02 | Exp: 2034-08-28

Device

(1)

50/1009248240Grant: 2016-02-02 | Exp: 2036-01-28

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 761123

351(a) ReferenceLicensedCDERInjection

Proper Name

anifrolumab-fnia

Applicant

AstraZeneca AB

Approval Date

30-Jul-21

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 9, 2024	SUPPL -5	View Letter (PDF)
Dec 5, 2023	SUPPL -3	View Letter (PDF)
Aug 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG/2ML(150MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2021-07-30 00:00:00

No patent or exclusivity listings for this strength.