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MOZOBIL Drug Profile

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 forty-four 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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Summary for MOZOBIL

International Patents:	44
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	89
Clinical Trials:	78
Patent Applications:	1,211
Drug Prices:	Drug price information for MOZOBIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOZOBIL
DailyMed Link:	MOZOBIL at DailyMed

Drug patent expirations by year for MOZOBIL

Generic Entry Opportunity Date for MOZOBIL

Generic Entry Date for MOZOBIL^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 022311 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

Sponsor	Phase
Stanford University	Phase 2
David Loeb	Phase 1
California Institute for Regenerative Medicine	Phase 1

See all MOZOBIL clinical trials

Recent Litigation for MOZOBIL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Genzyme Corporation v. Fresenius Kabi USA, LLC	2018-12-06
Genzyme Corporation v. Gland Pharma Limited	2018-07-19
Genzyme Corporation v. Zydus Pharmaceuticals (USA) Inc.	2016-06-29

See all MOZOBIL litigation

Pharmacology for MOZOBIL

Drug Class	Hematopoietic Stem Cell Mobilizer
Physiological Effect	Increased Hematopoietic Stem Cell Mobilization

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'-[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
AC1L22ET
AJ-81365
AK-41732
AKOS005266706
Amd 3100
AMD-3100
AMD3100
AMD3100 octahydrochloride
AN-436
ANW-73610
AOB5591
AS-42504
BC623053
BCP02337
BCPP000104
BDBM50035696
bicyclam JM-2987
BRD-K33240821-367-01-8
C28H54N8
CHEBI:125354
CHEMBL18442
CS-0451
CTK8C4952
D08971
DB06809
EX-A1762
FT-0660392
GNA & AMD-3100
GTPL844
HHA & AMD-3100
HY-10046
I14-9461
J-503718
JKL 169
JM 2987
JM 3100
JM 3100, AMD3100
JM-3100
JM3100
KS-00000OBY
L000104
LS-187299
MolPort-009-019-417
Mozobil (TN)
NCGC00165722-01
NCGC00165722-02
Plerixafor
plerixafor (amd3100)
Plerixafor (JAN/USAN/INN)
Plerixafor [USAN:INN:BAN]
Plerixafor-d4 (deuterated)
Plerixafor(AMD3100)
RL00426
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

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Glossary

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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

Expired US Patents for MOZOBIL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	Start Trial	Start Trial
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MOZOBIL

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Country	Patent Number	Estimated Expiration
Slovenia	1411918	Start Trial
Japan	2008195730	Start Trial
Lithuania	2371361	Start Trial
Poland	364673	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for MOZOBIL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2371361	CA 2019 00044	Denmark	Start Trial	PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/527/001 20090731
1411918	122012000044	Germany	Start Trial	PRODUCT NAME: PLERIXAFOR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER EIN METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	PA2012011	Lithuania	Start Trial	PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	1290023-9	Sweden	Start Trial	PRODUCT NAME: PLERIXAFOR, VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/09/534/001 20090804
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description