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.

The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the plerixafor profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mozobil

A generic version of MOZOBIL was approved as plerixafor by AMNEAL on July 24^th, 2023.

Summary for MOZOBIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	85
Patent Applications:	3,881
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

Recent Clinical Trials for MOZOBIL

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 2
Albert Einstein College of Medicine	Phase 1
Doris Duke Charitable Foundation	Phase 2

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

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

EU/EMA Drug Approvals for MOZOBIL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi B.V.	Mozobil	plerixafor	EMEA/H/C/001030 Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.,	Authorised	no	no	no	2009-07-30
Accord Healthcare S.L.U.	Plerixafor Accord	plerixafor	EMEA/H/C/005943 Adult patientsPlerixafor Accord is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2).Paediatric patients (1 to less than 18 years)Plerixafor Accord is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).	Authorised	yes	no	no	2022-12-16

International Patents for MOZOBIL

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

Country	Patent Number	Title	Estimated Expiration
Norway	305984
Portugal	619813
Brazil	0211570
Denmark	0619813
European Patent Office	0619813	POLYAMINES CYCLIQUES LIEES PRESENTANT UNE ACTIVITE CONTRE LE VIH (LINKED CYCLIC POLYAMINES WITH ACTIVITY AGAINST HIV)
Hungary	9401786

Supplementary Protection Certificates for MOZOBIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2371361	C02371361/01	Switzerland		PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63139 15.08.2014
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
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
1411918	C 2012 019	Romania		PRODUCT NAME: PLERIXAFOR SAU O SARE SAU UN COMPLEX METALIC ACCEPTABIL FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/537/001; DATE OF NATIONAL AUTHORISATION: 20090731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/537/001; DATE OF FIRST AUTHORISATION IN EEA: 20090731
1411918	300537	Netherlands		PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
1411918	92033	Luxembourg		92033, EXPIRES: 20240731