MOZOBIL Drug Patent 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 fifty-two 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.

DrugPatentWatch^® 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.

There is one tentative approval for the generic drug (plerixafor), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for MOZOBIL

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	84
Patent Applications:	3,873
Drug Prices:	Drug price information for MOZOBIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOZOBIL
What excipients (inactive ingredients) are in MOZOBIL?	MOZOBIL excipients list
DailyMed Link:	MOZOBIL at DailyMed

See drug prices for MOZOBIL

DrugPatentWatch^® Estimated 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.

Recent Clinical Trials for MOZOBIL

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

Sponsor	Phase
Albert Einstein College of Medicine	Phase 1
Doris Duke Charitable Foundation	Phase 2
David Loeb	Phase 1

See all MOZOBIL clinical trials

Pharmacology for MOZOBIL

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

Anatomical Therapeutic Chemical (ATC) Classes for MOZOBIL

L03AX	Other immunostimulants
L03A	IMMUNOSTIMULANTS
L03	IMMUNOSTIMULANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for MOZOBIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOZOBIL	Injection	plerixafor	24 mg/1.2 mL vials (20 mg/mL)	022311	3	2012-12-17

US Patents and Regulatory Information for MOZOBIL

MOZOBIL is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting 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

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

International Patents for MOZOBIL

See the table below for patents covering MOZOBIL around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	9401188
New Zealand	246179	LINKED CYCLIC POLYAMINES WITH ACTIVITY AGAINST HIV; PHARMACEUTICAL COMPOSITIONS
Portugal	619813
Norway	344632
European Patent Office	1223166

Supplementary Protection Certificates for MOZOBIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411918	C20120014 00064	Estonia		PRODUCT NAME: MOZOBIL - PLERIXAFOR;REG NO/DATE: C(2009)6238 31.07.2009
2371361	2019/055	Ireland		PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; NAT REGISTRATION NO/DATE: EU/1/09/537/001 20090804; FIRST REGISTRATION NO/DATE: EU/1/09/537/001 04/08/2009 (14/10/2020)
1411918	215 5011-2012	Slovakia		PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
2371361	CA 2019 00044	Denmark		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	PA2012011,C1411918	Lithuania		PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731