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Plerixafor - Generic Drug Details

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What are the generic drug sources for plerixafor and what is the scope of plerixafor freedom to operate?

Plerixafor is the generic ingredient in one branded drug marketed by Genzyme and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for plerixafor. One supplier is listed for this compound.

Summary for plerixafor

US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	77
Clinical Trials:	122
Patent Applications:	1,696
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for plerixafor
DailyMed Link:	plerixafor at DailyMed

Pharmacology for plerixafor

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

Synonyms for plerixafor

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-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

155148-31-5

3B1-000393

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

BC623053

BCPP000104

BDBM50035696

bicyclam JM-2987

BRD-K33240821-367-01-8

C28H54N8

CHEBI:125354

CHEMBL18442

CS-0451

CTK8C4952

D08971

D0L5RW

DB06809

FT-0660392

GNA & AMD-3100

GTPL844

HE070541

HE295036

HHA & AMD-3100

HY-10046

I14-9461

J-503718

JM 2987

JM 3100

JM 3100, AMD3100

JM-3100

JM3100

KS-00000OBY

L000104

LS-187299

MFCD05662218

MolPort-009-019-417

Mozobil

Mozobil (TN)

NCGC00165722-01

NCGC00165722-02

plerixafor (amd3100)

Plerixafor (INN/USAN)

Plerixafor (JAN/USAN/INN)

Plerixafor 8HCl

Plerixafor hcl

Plerixafor hydrochloride

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

US Patents and Regulatory Information for plerixafor

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
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008		RX	Yes	Yes
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008		RX	Yes	Yes			Y

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Expired US Patents for plerixafor

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

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International Patents for plerixafor

Country	Document Number	Estimated Expiration
Norway	20150674
European Patent Office	1223166
Cyprus	1112633
Norway	336989
Russian Federation	94031208

Supplementary Protection Certificates for plerixafor

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0002	France		PRODUCT NAME: PLERIXAFOR SOUS TOUTES SES FORMES, EN PARTICULIER SES SELS D'ADDITION AVEC UN ACIDE NON TOXIQUE OU SES COMPLEXES AVEC UN METAL; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
12/028	Ireland		PRODUCT NAME: PLERIXAFOR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2012 00026	Denmark
/2012	Austria		PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS ALS PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
5 5011-2012	Slovakia		PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: EU/1/09/537/001 20090804