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Last Updated: May 28, 2020

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MOZOBIL Drug Profile


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Which patents cover Mozobil, and when can generic versions of Mozobil launch?

Mozobil is a drug marketed by Genzyme and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty patent family members in twenty-seven countries.

The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the plerixafor profile page.

US ANDA Litigation and Generic Entry Outlook for Mozobil

Mozobil was eligible for patent challenges on December 15, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 22, 2023. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for MOZOBIL
Drug Prices for MOZOBIL

See drug prices for MOZOBIL

Generic Entry Opportunity Date for MOZOBIL
Generic Entry Date for MOZOBIL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MOZOBIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stanford UniversityPhase 2
David LoebPhase 1
Jonsson Comprehensive Cancer CenterPhase 1

See all MOZOBIL clinical trials

Recent Litigation for MOZOBIL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Genzyme Corporation v. Fresenius Kabi USA, LLC2018-12-06
Genzyme Corporation v. Gland Pharma Limited2018-07-19
Genzyme Corporation v. Zydus Pharmaceuticals (USA) Inc.2016-06-29

See all MOZOBIL litigation

Pharmacology for MOZOBIL
Synonyms for MOZOBIL
078P461
1-({4-[(1,4,8,11-tetraazacyclotetradecan-1-yl)methyl]phenyl}methyl)-1,4,8,11-tetraazacyclotetradecane
1-[[4-(1,4,8,11-tetrazacyclotetradec-1-ylmethyl)phenyl]methyl]-1,4,8,11-tetrazacyclotetradecane
1-{[4-(1,4,8,11-tetraazacyclotetradecan-1-ylmethyl)phenyl]methyl}-1,4,8,11-tetraazacyclotetradecane
1,1'-(benzene-1,4-diyldimethanediyl)bis(1,4,8,11-tetraazacyclotetradecane)
1,1'-[1,4-Phenylenebis(methylene)]bis-1,4,8,11-tetraazacyclotetradecane
1,1'-[1,4-phenylenebis(methylene)]bis(1,4,8,11-tetraazacyclotetradecane)
1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane]
1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane] & Galanthus nivalis agglutinin (GNA)
1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane] & Hippeastrum hybrid agglutinin( HHA)
1,1'-{1,4-phenylenebis(methylene)}-bis{1,4,8,11-tetraaza-cyclotetradecane}
1,1''''-{1,4-phenylenebis(methylene)}-bis{1,4,8,11-tetraaza-cyclotetradecane}
1,1'[1,4-phenylene-bis-(methylene)]-bis-1,4,8,11-tetraazacyclotetradecane
1,4-Bis((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzene
1,4,8,11-tetraazacyclotetradecanyl[4-(1,4,8,11-tetraazacyclotetradecanylmethyl)phenyl]methane
1,4,8,11-tetraazacyclotetradecanyl[4-(1,4,8,11-tetraazacyclotetradecanylmethyl)phenyl]methane(8HBr.2H2O)
11-{4-[4,8, 11-1,4,8,11tetraaza-cyclotetradec-1-ylmethyl]-benzyl}-1,4,8,11tetraaza-cyclotetradecane-1,4,8-tricarboxylic acid tri-tert-butyl ester
11''''-xylyl bis-1,4,8,11-tetraazacyclotetradecane
110078-46-1
4CA-1029
A25446
A809618
AB0009909
AB01566900_01
AB1008451
AC-26837
AK-41732
AKOS005266706
Amd 3100
AMD-3100
AMD3100
ANW-73610
AOB5591
AS-42504
BCP02337
BCPP000104
BDBM50035696
bicyclam JM-2987
BRD-K33240821-367-01-8
C28H54N8
CHEBI:125354
CHEMBL18442
CS-0451
CTK8C4952
D08971
DB06809
DTXSID70869520
EX-A1762
FT-0660392
GNA & AMD-3100
GTPL844
HHA & AMD-3100
HY-10046
J-503718
JKL 169
JM 2987
JM 3100
JM-3100
JM3100
KS-00000OBY
L000104
LS-187299
Mozobil (TN)
NCGC00165722-01
NCGC00165722-02
Plerixafor
plerixafor (amd3100)
Plerixafor (JAN/USAN/INN)
Plerixafor [USAN:INN:BAN]
Plerixafor 8HCl
Plerixafor hydrochloride
Plerixafor-d4 (deuterated)
Plerixafor(AMD3100)
plerixaforum
Q905835
S-7677
s8030
S915P5499N
SC-21932
SCHEMBL19038
SDZ SID 791
SID791
SR-01000941593
SR-01000941593-1
ST2414835
TC-162355
UNII-S915P5499N
YIQPUIGJQJDJOS-UHFFFAOYSA-N
Z2196779619
ZINC22443609
Paragraph IV (Patent) Challenges for MOZOBIL
Tradename Dosage Ingredient NDA Submissiondate
MOZOBIL SOLUTION;SUBCUTANEOUS plerixafor 022311 2012-12-17

US Patents and Regulatory Information for MOZOBIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for MOZOBIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411918 27/2012 Austria   Start Trial PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS ALS PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
0619813 SPC038/2009 Ireland   Start Trial SPC038/2009: 20101001, EXPIRES: 20171215
1411918 PA2012011 Lithuania   Start Trial PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361 PA2019018 Lithuania   Start Trial PRODUCT NAME: PLERIKSAFORAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA METALO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361 2019C/544 Belgium   Start Trial PRODUCT NAME: MOZOBIL - PLERIXAFOR; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Dow
Merck
Medtronic
Express Scripts
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.