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BLA

ANAKINRA | B103950 | BIOVITRUM AB

3 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

December 18, 2027(533 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Dec. 18, 2027	Active	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 31, 20456968 days remaining

Based on latest discovered patent 12377070(composition) · relevance 88/100

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

Discovered Patents

View all 170 patents →

Top 50 of 170 AI-discovered patents by relevance.

Composition

(29)

92/1007619066Grant: 2009-11-17 | Exp: 2029-11-12

92/1009409986Grant: 2016-08-09 | Exp: 2036-08-04

92/10010301647Grant: 2019-05-28 | Exp: 2039-05-23

92/10011155600Grant: 2021-10-26 | Exp: 2041-10-21

92/1008303945Grant: 2012-11-06 | Exp: 2032-11-01

92/1009200074Grant: 2015-12-01 | Exp: 2035-11-26

90/1006294170Grant: 2001-09-25 | Exp: 2021-09-20

90/1006399573Grant: 2002-06-04 | Exp: 2022-05-30

90/1007674464Grant: 2010-03-09 | Exp: 2030-03-04

90/10010167335Grant: 2019-01-01 | Exp: 2038-12-27

90/1007144988Grant: 2006-12-05 | Exp: 2026-11-30

90/1009163072Grant: 2015-10-20 | Exp: 2035-10-15

90/1006858409Grant: 2005-02-22 | Exp: 2025-02-17

90/1006733753Grant: 2004-05-11 | Exp: 2024-05-06

90/10011958886Grant: 2024-04-16 | Exp: 2044-04-11

88/1009447183Grant: 2016-09-20 | Exp: 2036-09-15

88/1008618054Grant: 2013-12-31 | Exp: 2033-12-26

88/1009085621Grant: 2015-07-21 | Exp: 2035-07-16

88/1008298533Grant: 2012-10-30 | Exp: 2032-10-25

88/1009534053Grant: 2017-01-03 | Exp: 2036-12-29

88/10011912761Grant: 2024-02-27 | Exp: 2044-02-22

88/10012377070Grant: 2025-08-05 | Exp: 2045-07-31

88/1008236559Grant: 2012-08-07 | Exp: 2032-08-02

88/1008518407Grant: 2013-08-27 | Exp: 2033-08-22

88/1007438910Grant: 2008-10-21 | Exp: 2028-10-16

88/1006437216Grant: 2002-08-20 | Exp: 2022-08-15

85/1007005413Grant: 2006-02-28 | Exp: 2026-02-23

85/1007482323Grant: 2009-01-27 | Exp: 2029-01-22

85/1008084426Grant: 2011-12-27 | Exp: 2031-12-22

Formulation

(5)

92/10011324807Grant: 2022-05-10 | Exp: 2042-05-05

92/1009198954Grant: 2015-12-01 | Exp: 2035-11-26

90/10010179162Grant: 2019-01-15 | Exp: 2039-01-10

90/10010765747Grant: 2020-09-08 | Exp: 2040-09-03

90/10010478394Grant: 2019-11-19 | Exp: 2039-11-14

Method of Use

(13)

95/10011091763Grant: 2021-08-17 | Exp: 2041-08-12

92/10011013786Grant: 2021-05-25 | Exp: 2041-05-20

92/1009919048Grant: 2018-03-20 | Exp: 2038-03-15

90/10011795217Grant: 2023-10-24 | Exp: 2043-10-19

90/1007087224Grant: 2006-08-08 | Exp: 2026-08-03

90/1007928074Grant: 2011-04-19 | Exp: 2031-04-14

90/1009683038Grant: 2017-06-20 | Exp: 2037-06-15

88/1009701728Grant: 2017-07-11 | Exp: 2037-07-06

88/1007572770Grant: 2009-08-11 | Exp: 2029-08-06

88/1008323635Grant: 2012-12-04 | Exp: 2032-11-29

88/1006497870Grant: 2002-12-24 | Exp: 2022-12-19

87/10011155614Grant: 2021-10-26 | Exp: 2041-10-21

85/1007867481Grant: 2011-01-11 | Exp: 2031-01-06

Manufacturing

(2)

88/10010208095Grant: 2019-02-19 | Exp: 2039-02-14

88/1006808902Grant: 2004-10-26 | Exp: 2024-10-21

Device

(1)

88/1009763875Grant: 2017-09-19 | Exp: 2037-09-14

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 103950

351(a) ReferenceLicensedCDERInjection

Proper Name

anakinra

Applicant

Swedish Orphan Biovitrum AB (publ)

Approval Date

14-Nov-01

Orphan Exclusivity

18-Dec-27

1y 5mo remaining

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Oct 28, 2025	SUPPL -5197	View Letter (PDF)
Sep 20, 2024	SUPPL -5198	View Letter (PDF)
Dec 22, 2020	SUPPL -5189	View Letter (PDF)
Jun 14, 2018	SUPPL -5182	View Letter (PDF)
May 20, 2016	SUPPL -5175	View Letter (PDF)
Oct 25, 2013	SUPPL -5150	View Letter (PDF)
Dec 28, 2012	SUPPL -5136	View Letter (PDF)
Oct 26, 2004	SUPPL -5039	View Letter (PDF)
Mar 17, 2004	SUPPL -5013	View Letter (PDF)
Mar 17, 2004	ORIG -1	View Letter (PDF)
Nov 6, 2003	SUPPL -5019	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MIU/VIAL

▴

VIAL; SUBCUTANEOUS | Approved: 2001-11-14 00:00:00

No patent or exclusivity listings for this strength.

#002 — 18MIU/VIAL

▾

VIAL; SUBCUTANEOUS | Approved: 2001-11-14 00:00:00

#003 — 25MIU/VIAL

▾

VIAL; SUBCUTANEOUS | Approved: 2001-11-14 00:00:00