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Plerixafor - Generic Drug Details

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What are the generic sources for plerixafor and what is the scope of patent protection?

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

Plerixafor has forty-one patent family members in twenty-six countries.

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

Summary for plerixafor

International Patents:	41
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	88
Clinical Trials:	129
Patent Applications:	2,185
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for plerixafor
DailyMed Link:	plerixafor at DailyMed

Recent Clinical Trials for plerixafor

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

Sponsor	Phase
Reproductive Medicine Associates of New Jersey	N/A
European Myeloma Network	Phase 2
EMN Research Italy	Phase 2

See all plerixafor clinical trials

Recent Litigation for plerixafor

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 plerixafor litigation

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-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

Mozobil (TN)

NCGC00165722-01

NCGC00165722-02

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 PLERIXAFOR

Tradename	Dosage	Ingredient	NDA	Submissiondate
MOZOBIL	SOLUTION;SUBCUTANEOUS	plerixafor	022311	2012-12-17

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

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

International Patents for plerixafor

Country	Patent Number	Estimated Expiration
South Korea	20040020075
Japan	2004538303
Cyprus	1112633
Germany	122012000044
Japan	2006526646
China	1561208

Supplementary Protection Certificates for plerixafor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411918	SPC/GB12/031	United Kingdom		PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTERED: UK EU/1/09/537/001 20090804
1411918	215 5011-2012	Slovakia		PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
0619813	SPC/GB10/004	United Kingdom		PRODUCT NAME: PLERIXAFOR IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTERED: UK EU/1/09/537/001 20090731; REASON FOR LAPSE: SURRENDERED
0619813	10C0002	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
1411918	C300537	Netherlands		PRODUCT NAME: PLERIXAFOR IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918	2012C/027	Belgium		PRODUCT NAME: PLERIXAFOR SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804