Viewing data from:

KEPIVANCE

BLA

PALIFERMIN | B125103 | BIOVITRUM AB

1 product0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 22, 20456898 days remaining

Based on latest discovered patent 12312381(manufacturing) · relevance 65/100

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

Discovered Patents

View all 29 patents →

29 AI-discovered patents, sorted by relevance.

Composition

(8)

85/1007667008Grant: 2010-02-23 | Exp: 2030-02-18

75/10010011642Grant: 2018-07-03 | Exp: 2038-06-28

70/1008030275Grant: 2011-10-04 | Exp: 2031-09-29

65/1009273106Grant: 2016-03-01 | Exp: 2036-02-25

50/1008361963Grant: 2013-01-29 | Exp: 2033-01-24

50/1007112659Grant: 2006-09-26 | Exp: 2026-09-21

50/1007186810Grant: 2007-03-06 | Exp: 2027-03-01

50/1007189827Grant: 2007-03-13 | Exp: 2027-03-08

Formulation

(3)

55/10012178873Grant: 2024-12-31 | Exp: 2044-12-26

50/10010166189Grant: 2019-01-01 | Exp: 2038-12-27

50/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

Manufacturing

(17)

65/10012312381Grant: 2025-05-27 | Exp: 2045-05-22

60/10012269843Grant: 2025-04-08 | Exp: 2045-04-03

55/1009359435Grant: 2016-06-07 | Exp: 2036-06-02

55/10012195779Grant: 2025-01-14 | Exp: 2045-01-09

55/10011254963Grant: 2022-02-22 | Exp: 2042-02-17

55/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

52/10011384378Grant: 2022-07-12 | Exp: 2042-07-07

50/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

50/1008354105Grant: 2013-01-15 | Exp: 2033-01-10

50/10011130980Grant: 2021-09-28 | Exp: 2041-09-23

50/1008952138Grant: 2015-02-10 | Exp: 2035-02-05

50/1007223742Grant: 2007-05-29 | Exp: 2027-05-24

50/10010513723Grant: 2019-12-24 | Exp: 2039-12-19

50/10011384140Grant: 2022-07-12 | Exp: 2042-07-07

50/1006210924Grant: 2001-04-03 | Exp: 2021-03-29

50/1009012178Grant: 2015-04-21 | Exp: 2035-04-16

50/10011486883Grant: 2022-11-01 | Exp: 2042-10-27

Diagnostic

(1)

75/10010400271Grant: 2019-09-03 | Exp: 2039-08-29

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 125103

351(a) ReferenceLicensedCDERFor Injection

Proper Name

palifermin

Applicant

Swedish Orphan Biovitrum AB (publ)

Approval Date

15-Dec-04

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 23, 2019	SUPPL -176	View Letter (PDF)
Jul 5, 2016	SUPPL -171	View Letter (PDF)
Mar 16, 2015	SUPPL -167	View Letter (PDF)
May 31, 2013	SUPPL -146	View Letter (PDF)
Nov 22, 2011	SUPPL -120	View Letter (PDF)
Dec 16, 2005	SUPPL -10	View Letter (PDF)
Dec 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MCG/KG/DAY

▴

INJECTABLE; INJECTION | Approved: 2004-12-15 00:00:00

No patent or exclusivity listings for this strength.