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BLA

PALIVIZUMAB | B103770 | SWEDISH ORPHAN

2 products0 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

Dec. 19, 20446744 days remaining

Based on latest discovered patent 12173050(composition) · relevance 95/100

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

Discovered Patents

View all 109 patents →

Top 50 of 109 AI-discovered patents by relevance.

Composition

(34)

95/1008568726Grant: 2013-10-29 | Exp: 2033-10-24

95/10012173050Grant: 2024-12-24 | Exp: 2044-12-19

95/1007700735Grant: 2010-04-20 | Exp: 2030-04-15

95/1007229618Grant: 2007-06-12 | Exp: 2027-06-07

95/10010723786Grant: 2020-07-28 | Exp: 2040-07-23

92/10010689437Grant: 2020-06-23 | Exp: 2040-06-18

92/1007364742Grant: 2008-04-29 | Exp: 2028-04-24

92/10011084850Grant: 2021-08-10 | Exp: 2041-08-05

92/1009283274Grant: 2016-03-15 | Exp: 2036-03-10

92/1008153133Grant: 2012-04-10 | Exp: 2032-04-05

92/1009321831Grant: 2016-04-26 | Exp: 2036-04-21

92/10010035843Grant: 2018-07-31 | Exp: 2038-07-26

90/10011661449Grant: 2023-05-30 | Exp: 2043-05-25

90/10010059757Grant: 2018-08-28 | Exp: 2038-08-23

90/1006955717Grant: 2005-10-18 | Exp: 2025-10-13

89/1008562994Grant: 2013-10-22 | Exp: 2033-10-17

89/1008562996Grant: 2013-10-22 | Exp: 2033-10-17

89/1009913894Grant: 2018-03-13 | Exp: 2038-03-08

89/10012116401Grant: 2024-10-15 | Exp: 2044-10-10

88/10011186628Grant: 2021-11-30 | Exp: 2041-11-25

88/1009096658Grant: 2015-08-04 | Exp: 2035-07-30

88/1008852608Grant: 2014-10-07 | Exp: 2034-10-02

88/1007786273Grant: 2010-08-31 | Exp: 2030-08-26

87/10011248039Grant: 2022-02-15 | Exp: 2042-02-10

86/10010730931Grant: 2020-08-04 | Exp: 2040-07-30

86/10010758607Grant: 2020-09-01 | Exp: 2040-08-27

85/1007704505Grant: 2010-04-27 | Exp: 2030-04-22

85/1007700720Grant: 2010-04-20 | Exp: 2030-04-15

85/10010501528Grant: 2019-12-10 | Exp: 2039-12-05

85/10011229692Grant: 2022-01-25 | Exp: 2042-01-20

85/10010016496Grant: 2018-07-10 | Exp: 2038-07-05

85/1009499590Grant: 2016-11-22 | Exp: 2036-11-17

80/1007670600Grant: 2010-03-02 | Exp: 2030-02-25

75/1007704720Grant: 2010-04-27 | Exp: 2030-04-22

Formulation

(12)

98/1009879067Grant: 2018-01-30 | Exp: 2038-01-25

96/10011286294Grant: 2022-03-29 | Exp: 2042-03-24

95/1007132100Grant: 2006-11-07 | Exp: 2026-11-02

95/1008460663Grant: 2013-06-11 | Exp: 2033-06-06

95/1008206951Grant: 2012-06-26 | Exp: 2032-06-21

95/1009272032Grant: 2016-03-01 | Exp: 2036-02-25

95/1007294336Grant: 2007-11-13 | Exp: 2027-11-08

95/10010774133Grant: 2020-09-15 | Exp: 2040-09-10

92/1008007793Grant: 2011-08-30 | Exp: 2031-08-25

92/1007785592Grant: 2010-08-31 | Exp: 2030-08-26

92/1008986686Grant: 2015-03-24 | Exp: 2035-03-19

90/10011667698Grant: 2023-06-06 | Exp: 2043-06-01

Method of Use

(3)

95/10012024553Grant: 2024-07-02 | Exp: 2044-06-27

88/1007208162Grant: 2007-04-24 | Exp: 2027-04-19

75/1009476049Grant: 2016-10-25 | Exp: 2036-10-20

Diagnostic

(1)

80/10010100372Grant: 2018-10-16 | Exp: 2038-10-11

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 103770 | 4 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

palivizumab

Applicant

Swedish Orphan Biovitrum AB (publ)

Approval Date

19-Jun-98

Presentations

50MG — Single-Dose Vial (Intramuscular)

100MG — Single-Dose Vial (Intramuscular)

50MG/0.5ML — Single-Dose Vial (Intramuscular)

100MG/1ML — Single-Dose Vial (Intramuscular)

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
May 17, 2017	SUPPL -5200	View Letter (PDF)
Mar 24, 2014	SUPPL -5185	View Letter (PDF)
Apr 6, 2012	SUPPL -5161	View Letter (PDF)
May 17, 2011	SUPPL -5153	View Letter (PDF)
Mar 24, 2009	SUPPL -5116	View Letter (PDF)
Aug 5, 2008	SUPPL -5113	View Letter (PDF)
Mar 6, 2007	SUPPL -5096	View Letter (PDF)
Mar 3, 2005	SUPPL -5059	View Letter (PDF)
Mar 29, 2004	SUPPL -5022	View Letter (PDF)
Mar 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/VIAL

▴

VIAL | Approved: 1998-06-19 00:00:00

No patent or exclusivity listings for this strength.

#002 — 50MG/VIAL

▾

VIAL | Approved: 1998-06-19 00:00:00