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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in twenty-nine 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.

Summary for MOZOBIL

International Patents:	72
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	78
Clinical Trials:	75
Patent Applications:	856
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOZOBIL
DailyMed Link:	MOZOBIL at DailyMed

Generic Entry Opportunity Date for MOZOBIL

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.

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-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 (TN)

NCGC00165722-01

NCGC00165722-02

Plerixafor

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 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
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 MOZOBIL

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

Paragraph IV (Patent) Challenges for MOZOBIL

Drugname	Dosage	Strength	RLD	Date
	Injection	24 mg/1.2 mL vials (20 mg/mL)

Non-Orange Book US Patents for MOZOBIL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,583,131	Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity
7,169,750	Methods to mobilize progenitor/stem cells
7,935,692	Methods to mobilize progenitor/stem cells

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International Patents for MOZOBIL

Country	Document Number	Estimated Expiration
Denmark	0619813
Hungary	T67544
World Intellectual Property Organization (WIPO)	2005000333
Russian Federation	2309741

Supplementary Protection Certificates for MOZOBIL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2009 00052	Denmark
C/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
2012011	Lithuania		PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2012 00026	Denmark